Dermatology

WASHINGTON – Eczema is an independent risk factor for mental health impairment among American children, according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.

Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.

Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.

Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.

The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.

Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.

About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.

When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.

When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.

In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.

Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.

The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.

It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”

Dr. Wan reported receiving research fellowship funding from Pfizer.

egreb@mdedge.com

WASHINGTON – Eczema is an independent risk factor for mental health impairment among American children, according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.

Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.

Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.

Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.

The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.

Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.

About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.

When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.

When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.

In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.

Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.

The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.

It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”

Dr. Wan reported receiving research fellowship funding from Pfizer.

egreb@mdedge.com

WASHINGTON – Eczema is an independent risk factor for mental health impairment among American children, according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.

Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.

Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.

Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.

The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.

Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.

About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.

When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.

When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.

In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.

Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.

The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.

It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”

Dr. Wan reported receiving research fellowship funding from Pfizer.

egreb@mdedge.com

DIAGNOSIS, TREATMENT, CONTROL

The differential diagnosis of Norwegian scabies includes psoriasis, eczema, contact dermatitis, insect bites, seborrheic dermatitis, lichen planus, systemic infection, palmoplantar keratoderma, and cutaneous lymphoma.²

Treatment involves eradicating the infestation with a topical ointment consisting of permethrin, crotamiton, lindane, benzyl benzoate, and sulfur, applied directly to the skin. However, topical treatments often cannot penetrate the crusted and thickened skin, leading to treatment failure. A dose of oral ivermectin 200 µg/kg on days 1, 2, and 8 is a safe, effective, first-line treatment for Norwegian scabies, rapidly reducing scabies symptoms.³ Adverse effects of oral ivermectin are rare and usually minor.

Norwegian scabies is extremely contagious, spread by close physical contact and sharing of contaminated items such as clothing, bedding, towels, and furniture. Scabies mites can survive off the skin for 48 to 72 hours at room temperature.⁴ Potentially contaminated items should be decontaminated by washing in hot water and drying in a drying machine or by dry cleaning. Body contact with other contaminated items should be avoided for at least 72 hours.

Outbreaks can spread among patients, visitors, and medical staff in institutions such as nursing homes, day care centers, long-term-care facilities, and hospitals.⁵ Early identification facilitates appropriate management and treatment, thereby preventing infection and community-wide scabies outbreaks.          

Acknowledgment: The authors would like to sincerely thank Paul Williams for his editing of the article.

DIAGNOSIS, TREATMENT, CONTROL

The differential diagnosis of Norwegian scabies includes psoriasis, eczema, contact dermatitis, insect bites, seborrheic dermatitis, lichen planus, systemic infection, palmoplantar keratoderma, and cutaneous lymphoma.²

Treatment involves eradicating the infestation with a topical ointment consisting of permethrin, crotamiton, lindane, benzyl benzoate, and sulfur, applied directly to the skin. However, topical treatments often cannot penetrate the crusted and thickened skin, leading to treatment failure. A dose of oral ivermectin 200 µg/kg on days 1, 2, and 8 is a safe, effective, first-line treatment for Norwegian scabies, rapidly reducing scabies symptoms.³ Adverse effects of oral ivermectin are rare and usually minor.

Norwegian scabies is extremely contagious, spread by close physical contact and sharing of contaminated items such as clothing, bedding, towels, and furniture. Scabies mites can survive off the skin for 48 to 72 hours at room temperature.⁴ Potentially contaminated items should be decontaminated by washing in hot water and drying in a drying machine or by dry cleaning. Body contact with other contaminated items should be avoided for at least 72 hours.

Outbreaks can spread among patients, visitors, and medical staff in institutions such as nursing homes, day care centers, long-term-care facilities, and hospitals.⁵ Early identification facilitates appropriate management and treatment, thereby preventing infection and community-wide scabies outbreaks.          

Acknowledgment: The authors would like to sincerely thank Paul Williams for his editing of the article.

DIAGNOSIS, TREATMENT, CONTROL

The differential diagnosis of Norwegian scabies includes psoriasis, eczema, contact dermatitis, insect bites, seborrheic dermatitis, lichen planus, systemic infection, palmoplantar keratoderma, and cutaneous lymphoma.²

Treatment involves eradicating the infestation with a topical ointment consisting of permethrin, crotamiton, lindane, benzyl benzoate, and sulfur, applied directly to the skin. However, topical treatments often cannot penetrate the crusted and thickened skin, leading to treatment failure. A dose of oral ivermectin 200 µg/kg on days 1, 2, and 8 is a safe, effective, first-line treatment for Norwegian scabies, rapidly reducing scabies symptoms.³ Adverse effects of oral ivermectin are rare and usually minor.

Norwegian scabies is extremely contagious, spread by close physical contact and sharing of contaminated items such as clothing, bedding, towels, and furniture. Scabies mites can survive off the skin for 48 to 72 hours at room temperature.⁴ Potentially contaminated items should be decontaminated by washing in hot water and drying in a drying machine or by dry cleaning. Body contact with other contaminated items should be avoided for at least 72 hours.

Outbreaks can spread among patients, visitors, and medical staff in institutions such as nursing homes, day care centers, long-term-care facilities, and hospitals.⁵ Early identification facilitates appropriate management and treatment, thereby preventing infection and community-wide scabies outbreaks.          

Acknowledgment: The authors would like to sincerely thank Paul Williams for his editing of the article.

When this 45-year-old man was in third grade, he began to notice areas of hair loss in his scalp. The affected area was always round and the hair loss complete—but it would grow back entirely within weeks to months. There was never any rash or discomfort associated with these changes.

Since then, he has experienced numerous similar episodes of focal hair loss, sometimes in the beard, sometimes on the arms or legs, and most recently, in his eyebrows. Again, no symptoms accompany the process.

Although his personal health history is relatively uneventful, his family has not been as fortunate. There are numerous cases of lupus, rheumatoid arthritis, diabetes, and thyroid disease.

EXAMINATION
There are sharply defined, crescent-shaped, 2.5-cm divots at the superior borders of both eyebrows in which every hair is gone. No redness, swelling, or scaling are seen or felt, and there is no detectable adenopathy in the region.

Examination of hair-bearing regions reveals no other areas of hair loss.

What’s the diagnosis?

DISCUSSION
This case illustrates several variants of an extremely common condition: alopecia areata (AA), literally translated as “hair loss confined to a particular localized area or areas.” Although AA is more common in adults, it often affects children. And though the scalp is by far the most commonly affected area, AA can cause hair loss anywhere on the body.

In general, the earlier the onset, the more likely the problem is to become recurrent or even progressive. In rare instances, a patient can develop alopecia totalis, in which there is permanent and total scalp hair loss, or even alopecia universalis, the permanent loss of every hair on the entire body. Other predictors of a poor prognosis include extensive involvement of the scalp, especially the periphery (termed ophiasis), and a history of atopy.

Much research has been done on the underlying pathology of AA, as well as potential remedies. This has proven, beyond any doubt, that the problem is autoimmune and tends to run in families (as with other autoimmune diseases), suggesting a hereditary basis. We also know that medications that dampen this autoimmune process, such as steroids and biologics, are useful but not always safe or practical.

What we don’t really know is what triggers an actual attack. My observation, based on 35 years of dermatology practice, is that stress often plays a part—but I’d be hard pressed to prove that, and it wouldn’t be very useful even if I could. This patient adamantly agreed that stress was the trigger for his AA.

The differential for AA includes tinea capitis, discoid lupus, and lichen planopilaris. This patient’s multiple episodes over decades made the correct diagnosis clear. However, when the diagnosis is in doubt—other items in the differential commonly affect the scalp, although they may also manifest with redness, scaling, or swelling—a punch biopsy may be necessary to sort through the possibilities. Care must be taken to enter the skin parallel to hair follicles when the sample is removed.

Many treatments have been tried for AA, but none are reliably effective. In the vast majority of patients, the problem resolves itself. Treatments to try when needed include topical steroids, intralesional steroids, and topical immune stimulators (eg, squaric acid or dinitrochlorobenzene)—all of which have their limitations.

TAKE-HOME LEARNING POINTS

• Alopecia areata (AA) is more common in adults but can affect children as well.
• In rare cases, the patient can experience permanent total hair loss on the scalp (alopecia totalis) or the entire body (alopecia universalis).
• Because AA is an autoimmune disease, steroids and biologics may be useful treatments—but they are not always safe or practical.
• In a majority of patients with AA, the problem will resolve on its own.

When this 45-year-old man was in third grade, he began to notice areas of hair loss in his scalp. The affected area was always round and the hair loss complete—but it would grow back entirely within weeks to months. There was never any rash or discomfort associated with these changes.

Since then, he has experienced numerous similar episodes of focal hair loss, sometimes in the beard, sometimes on the arms or legs, and most recently, in his eyebrows. Again, no symptoms accompany the process.

Although his personal health history is relatively uneventful, his family has not been as fortunate. There are numerous cases of lupus, rheumatoid arthritis, diabetes, and thyroid disease.

EXAMINATION
There are sharply defined, crescent-shaped, 2.5-cm divots at the superior borders of both eyebrows in which every hair is gone. No redness, swelling, or scaling are seen or felt, and there is no detectable adenopathy in the region.

Examination of hair-bearing regions reveals no other areas of hair loss.

What’s the diagnosis?

DISCUSSION
This case illustrates several variants of an extremely common condition: alopecia areata (AA), literally translated as “hair loss confined to a particular localized area or areas.” Although AA is more common in adults, it often affects children. And though the scalp is by far the most commonly affected area, AA can cause hair loss anywhere on the body.

In general, the earlier the onset, the more likely the problem is to become recurrent or even progressive. In rare instances, a patient can develop alopecia totalis, in which there is permanent and total scalp hair loss, or even alopecia universalis, the permanent loss of every hair on the entire body. Other predictors of a poor prognosis include extensive involvement of the scalp, especially the periphery (termed ophiasis), and a history of atopy.

Much research has been done on the underlying pathology of AA, as well as potential remedies. This has proven, beyond any doubt, that the problem is autoimmune and tends to run in families (as with other autoimmune diseases), suggesting a hereditary basis. We also know that medications that dampen this autoimmune process, such as steroids and biologics, are useful but not always safe or practical.

What we don’t really know is what triggers an actual attack. My observation, based on 35 years of dermatology practice, is that stress often plays a part—but I’d be hard pressed to prove that, and it wouldn’t be very useful even if I could. This patient adamantly agreed that stress was the trigger for his AA.

The differential for AA includes tinea capitis, discoid lupus, and lichen planopilaris. This patient’s multiple episodes over decades made the correct diagnosis clear. However, when the diagnosis is in doubt—other items in the differential commonly affect the scalp, although they may also manifest with redness, scaling, or swelling—a punch biopsy may be necessary to sort through the possibilities. Care must be taken to enter the skin parallel to hair follicles when the sample is removed.

Many treatments have been tried for AA, but none are reliably effective. In the vast majority of patients, the problem resolves itself. Treatments to try when needed include topical steroids, intralesional steroids, and topical immune stimulators (eg, squaric acid or dinitrochlorobenzene)—all of which have their limitations.

TAKE-HOME LEARNING POINTS

• Alopecia areata (AA) is more common in adults but can affect children as well.
• In rare cases, the patient can experience permanent total hair loss on the scalp (alopecia totalis) or the entire body (alopecia universalis).
• Because AA is an autoimmune disease, steroids and biologics may be useful treatments—but they are not always safe or practical.
• In a majority of patients with AA, the problem will resolve on its own.

When this 45-year-old man was in third grade, he began to notice areas of hair loss in his scalp. The affected area was always round and the hair loss complete—but it would grow back entirely within weeks to months. There was never any rash or discomfort associated with these changes.

Since then, he has experienced numerous similar episodes of focal hair loss, sometimes in the beard, sometimes on the arms or legs, and most recently, in his eyebrows. Again, no symptoms accompany the process.

Although his personal health history is relatively uneventful, his family has not been as fortunate. There are numerous cases of lupus, rheumatoid arthritis, diabetes, and thyroid disease.

EXAMINATION
There are sharply defined, crescent-shaped, 2.5-cm divots at the superior borders of both eyebrows in which every hair is gone. No redness, swelling, or scaling are seen or felt, and there is no detectable adenopathy in the region.

Examination of hair-bearing regions reveals no other areas of hair loss.

What’s the diagnosis?

DISCUSSION
This case illustrates several variants of an extremely common condition: alopecia areata (AA), literally translated as “hair loss confined to a particular localized area or areas.” Although AA is more common in adults, it often affects children. And though the scalp is by far the most commonly affected area, AA can cause hair loss anywhere on the body.

In general, the earlier the onset, the more likely the problem is to become recurrent or even progressive. In rare instances, a patient can develop alopecia totalis, in which there is permanent and total scalp hair loss, or even alopecia universalis, the permanent loss of every hair on the entire body. Other predictors of a poor prognosis include extensive involvement of the scalp, especially the periphery (termed ophiasis), and a history of atopy.

Much research has been done on the underlying pathology of AA, as well as potential remedies. This has proven, beyond any doubt, that the problem is autoimmune and tends to run in families (as with other autoimmune diseases), suggesting a hereditary basis. We also know that medications that dampen this autoimmune process, such as steroids and biologics, are useful but not always safe or practical.

What we don’t really know is what triggers an actual attack. My observation, based on 35 years of dermatology practice, is that stress often plays a part—but I’d be hard pressed to prove that, and it wouldn’t be very useful even if I could. This patient adamantly agreed that stress was the trigger for his AA.

The differential for AA includes tinea capitis, discoid lupus, and lichen planopilaris. This patient’s multiple episodes over decades made the correct diagnosis clear. However, when the diagnosis is in doubt—other items in the differential commonly affect the scalp, although they may also manifest with redness, scaling, or swelling—a punch biopsy may be necessary to sort through the possibilities. Care must be taken to enter the skin parallel to hair follicles when the sample is removed.

Many treatments have been tried for AA, but none are reliably effective. In the vast majority of patients, the problem resolves itself. Treatments to try when needed include topical steroids, intralesional steroids, and topical immune stimulators (eg, squaric acid or dinitrochlorobenzene)—all of which have their limitations.

TAKE-HOME LEARNING POINTS

• Alopecia areata (AA) is more common in adults but can affect children as well.
• In rare cases, the patient can experience permanent total hair loss on the scalp (alopecia totalis) or the entire body (alopecia universalis).
• Because AA is an autoimmune disease, steroids and biologics may be useful treatments—but they are not always safe or practical.
• In a majority of patients with AA, the problem will resolve on its own.

The FP was concerned that this could be melanoma.

He used his dermatoscope and saw suspicious patterns that included polygonal lines and circle-within-circle patterns. He informed the patient about his concerns for melanoma and discussed the need for a biopsy. After obtaining informed consent, the FP injected the patient’s nose with 1% lidocaine and epinephrine for anesthesia and to prevent bleeding. Remember, it is safe to use injectable epinephrine along with lidocaine when doing surgery on the nose. (See “Biopsies for skin cancer detection: Dispelling the myths”). The FP used a Dermablade to perform a broad shave biopsy, which revealed a lentigo maligna melanoma in situ (also known as lentigo maligna). (See the Watch & Learn video on “Shave biopsy”)

During the follow-up visit, the FP presented the patient with 2 options for treatment: topical imiquimod for 3 months or Mohs surgery. The FP recommended Mohs surgery because the data for topical imiquimod in the treatment of lentigo maligna indicate that it is less effective on the nose than other areas of the face. The patient agreed to surgery, and the FP sent the referral and the photo of the original lesion to the Mohs surgeon. The outcome was good, and the need for ongoing sun safety and regular skin surveillance was explained to the patient.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine, 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP was concerned that this could be melanoma.

He used his dermatoscope and saw suspicious patterns that included polygonal lines and circle-within-circle patterns. He informed the patient about his concerns for melanoma and discussed the need for a biopsy. After obtaining informed consent, the FP injected the patient’s nose with 1% lidocaine and epinephrine for anesthesia and to prevent bleeding. Remember, it is safe to use injectable epinephrine along with lidocaine when doing surgery on the nose. (See “Biopsies for skin cancer detection: Dispelling the myths”). The FP used a Dermablade to perform a broad shave biopsy, which revealed a lentigo maligna melanoma in situ (also known as lentigo maligna). (See the Watch & Learn video on “Shave biopsy”)

During the follow-up visit, the FP presented the patient with 2 options for treatment: topical imiquimod for 3 months or Mohs surgery. The FP recommended Mohs surgery because the data for topical imiquimod in the treatment of lentigo maligna indicate that it is less effective on the nose than other areas of the face. The patient agreed to surgery, and the FP sent the referral and the photo of the original lesion to the Mohs surgeon. The outcome was good, and the need for ongoing sun safety and regular skin surveillance was explained to the patient.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine, 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP was concerned that this could be melanoma.

He used his dermatoscope and saw suspicious patterns that included polygonal lines and circle-within-circle patterns. He informed the patient about his concerns for melanoma and discussed the need for a biopsy. After obtaining informed consent, the FP injected the patient’s nose with 1% lidocaine and epinephrine for anesthesia and to prevent bleeding. Remember, it is safe to use injectable epinephrine along with lidocaine when doing surgery on the nose. (See “Biopsies for skin cancer detection: Dispelling the myths”). The FP used a Dermablade to perform a broad shave biopsy, which revealed a lentigo maligna melanoma in situ (also known as lentigo maligna). (See the Watch & Learn video on “Shave biopsy”)

During the follow-up visit, the FP presented the patient with 2 options for treatment: topical imiquimod for 3 months or Mohs surgery. The FP recommended Mohs surgery because the data for topical imiquimod in the treatment of lentigo maligna indicate that it is less effective on the nose than other areas of the face. The patient agreed to surgery, and the FP sent the referral and the photo of the original lesion to the Mohs surgeon. The outcome was good, and the need for ongoing sun safety and regular skin surveillance was explained to the patient.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine, 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

WAIKOLOA, HAWAII – Pediatric dermatologist Andrea L. Zaenglein, MD, has composed a whimsical couplet to help physicians broaden their differential diagnosis for acneiform rashes in children.

Pustules on noses: Think demodicosis!

The classic teaching has been that Demodex carriage and its pathologic clinical expression, demodicosis, are rare in children. Not so, Dr. Zaenglein asserted at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

“One of the things that we never used to see in kids but now I see all the time, probably because I’m looking for it, is Demodex. You’re not born with Demodex. Your carriage rate will increase over the years and by the time you’re elderly, 95% of us will have it – but not me. I just decided I’m not having these. I’m not looking for them, and I don’t want to know if they’re there,” she quipped, referring to the creepiness factor surrounding these facial parasitic mites invisible to the naked eye.

The mites live in pilosebaceous units. In animals, the disease is called mange. In humans, demodicosis is caused by two species of mites: Demodex folliculorum and D. brevis. The diagnosis is made by microscopic examination of mineral oil skin scrapings.

Primary demodicosis can take the form of pityriasis folliculorum, also known as spinulate demodicosis, papulopustular perioral, periauricular, or periorbital demodicosis, or a nodulocystic/conglobate version.

More commonly, however, Demodex is a secondary player in pediatric acneiform rashes, including periorbital dermatitis, steroid dermatitis, midchildhood acne, and rosacea.

Courtesy Gary White, MD

“Demodicosis can be associated with immunosuppression. Kids with Langerhans cell histiocytosis seem to be prone to it. But you can see it in kids who don’t have any underlying immunosuppression, and I think there are more and more cases of that as we go looking for it,” said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey, and immediate past president of the Society for Pediatric Dermatology.

Look for Demodex in children with somewhat atypical versions of common acneiform eruptions: for example, the ‘pustules on noses’ variant.

“Finding Demodex can alter your treatment and make it easier in these cases,” she said.

Metronidazole and ivermectin are the systemic treatment options for pediatric demodicosis.

“I tend to use topical permethrin, just because it’s easy to get. I’ll treat them once a week for 3 weeks in a row. But also make sure to treat the underlying primary inflammatory disorder,” the pediatric dermatologist advised.

Other topical options include ivermectin cream, crotamiton cream, metronidazole gel, and salicylic acid cream.

Dr. Zaenglein reported having financial relationships with Sun Pharmaceuticals, Allergan, and Ortho Dermatologics.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@mdedge.com

WAIKOLOA, HAWAII – Pediatric dermatologist Andrea L. Zaenglein, MD, has composed a whimsical couplet to help physicians broaden their differential diagnosis for acneiform rashes in children.

Pustules on noses: Think demodicosis!

The classic teaching has been that Demodex carriage and its pathologic clinical expression, demodicosis, are rare in children. Not so, Dr. Zaenglein asserted at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

“One of the things that we never used to see in kids but now I see all the time, probably because I’m looking for it, is Demodex. You’re not born with Demodex. Your carriage rate will increase over the years and by the time you’re elderly, 95% of us will have it – but not me. I just decided I’m not having these. I’m not looking for them, and I don’t want to know if they’re there,” she quipped, referring to the creepiness factor surrounding these facial parasitic mites invisible to the naked eye.

The mites live in pilosebaceous units. In animals, the disease is called mange. In humans, demodicosis is caused by two species of mites: Demodex folliculorum and D. brevis. The diagnosis is made by microscopic examination of mineral oil skin scrapings.

Primary demodicosis can take the form of pityriasis folliculorum, also known as spinulate demodicosis, papulopustular perioral, periauricular, or periorbital demodicosis, or a nodulocystic/conglobate version.

More commonly, however, Demodex is a secondary player in pediatric acneiform rashes, including periorbital dermatitis, steroid dermatitis, midchildhood acne, and rosacea.

Courtesy Gary White, MD

“Demodicosis can be associated with immunosuppression. Kids with Langerhans cell histiocytosis seem to be prone to it. But you can see it in kids who don’t have any underlying immunosuppression, and I think there are more and more cases of that as we go looking for it,” said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey, and immediate past president of the Society for Pediatric Dermatology.

Look for Demodex in children with somewhat atypical versions of common acneiform eruptions: for example, the ‘pustules on noses’ variant.

“Finding Demodex can alter your treatment and make it easier in these cases,” she said.

Metronidazole and ivermectin are the systemic treatment options for pediatric demodicosis.

“I tend to use topical permethrin, just because it’s easy to get. I’ll treat them once a week for 3 weeks in a row. But also make sure to treat the underlying primary inflammatory disorder,” the pediatric dermatologist advised.

Other topical options include ivermectin cream, crotamiton cream, metronidazole gel, and salicylic acid cream.

Dr. Zaenglein reported having financial relationships with Sun Pharmaceuticals, Allergan, and Ortho Dermatologics.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@mdedge.com

WAIKOLOA, HAWAII – Pediatric dermatologist Andrea L. Zaenglein, MD, has composed a whimsical couplet to help physicians broaden their differential diagnosis for acneiform rashes in children.

Pustules on noses: Think demodicosis!

The classic teaching has been that Demodex carriage and its pathologic clinical expression, demodicosis, are rare in children. Not so, Dr. Zaenglein asserted at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

“One of the things that we never used to see in kids but now I see all the time, probably because I’m looking for it, is Demodex. You’re not born with Demodex. Your carriage rate will increase over the years and by the time you’re elderly, 95% of us will have it – but not me. I just decided I’m not having these. I’m not looking for them, and I don’t want to know if they’re there,” she quipped, referring to the creepiness factor surrounding these facial parasitic mites invisible to the naked eye.

The mites live in pilosebaceous units. In animals, the disease is called mange. In humans, demodicosis is caused by two species of mites: Demodex folliculorum and D. brevis. The diagnosis is made by microscopic examination of mineral oil skin scrapings.

Primary demodicosis can take the form of pityriasis folliculorum, also known as spinulate demodicosis, papulopustular perioral, periauricular, or periorbital demodicosis, or a nodulocystic/conglobate version.

More commonly, however, Demodex is a secondary player in pediatric acneiform rashes, including periorbital dermatitis, steroid dermatitis, midchildhood acne, and rosacea.

Courtesy Gary White, MD

“Demodicosis can be associated with immunosuppression. Kids with Langerhans cell histiocytosis seem to be prone to it. But you can see it in kids who don’t have any underlying immunosuppression, and I think there are more and more cases of that as we go looking for it,” said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey, and immediate past president of the Society for Pediatric Dermatology.

Look for Demodex in children with somewhat atypical versions of common acneiform eruptions: for example, the ‘pustules on noses’ variant.

“Finding Demodex can alter your treatment and make it easier in these cases,” she said.

Metronidazole and ivermectin are the systemic treatment options for pediatric demodicosis.

“I tend to use topical permethrin, just because it’s easy to get. I’ll treat them once a week for 3 weeks in a row. But also make sure to treat the underlying primary inflammatory disorder,” the pediatric dermatologist advised.

Other topical options include ivermectin cream, crotamiton cream, metronidazole gel, and salicylic acid cream.

Dr. Zaenglein reported having financial relationships with Sun Pharmaceuticals, Allergan, and Ortho Dermatologics.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@mdedge.com

A safety signal of pulmonary embolism and increased mortality has emerged in a postmarketing trial of tofacitinib (Xeljanz) in patients with rheumatoid arthritis, the Food and Drug Administration reported.

The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.

Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.

The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.

Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.

The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.

“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.

Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.

“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.

While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.

A safety signal of pulmonary embolism and increased mortality has emerged in a postmarketing trial of tofacitinib (Xeljanz) in patients with rheumatoid arthritis, the Food and Drug Administration reported.

The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.

Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.

The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.

Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.

The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.

“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.

Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.

“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.

While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.

A safety signal of pulmonary embolism and increased mortality has emerged in a postmarketing trial of tofacitinib (Xeljanz) in patients with rheumatoid arthritis, the Food and Drug Administration reported.

The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.

Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.

The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.

Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.

The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.

“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.

Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.

“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.

While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.

The Food and Drug Administration will seek more safety and efficacy data on 12 active sunscreen ingredients, including some of those frequently used in over-the-counter products.

Wavebreakmedia Ltd/Thinkstock

The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.

There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.

OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).

“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”

Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information

Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.

However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said

“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.

In addition to seeking these additional data, the rule also proposes the following:

• Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
• The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
• Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
• New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
• Products that combine sunscreens with insect repellents are not GRASE.

In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”

To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.

msullivan@mdedge.com

The Food and Drug Administration will seek more safety and efficacy data on 12 active sunscreen ingredients, including some of those frequently used in over-the-counter products.

Wavebreakmedia Ltd/Thinkstock

The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.

There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.

OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).

“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”

Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information

Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.

However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said

“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.

In addition to seeking these additional data, the rule also proposes the following:

• Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
• The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
• Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
• New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
• Products that combine sunscreens with insect repellents are not GRASE.

In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”

To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.

msullivan@mdedge.com

The Food and Drug Administration will seek more safety and efficacy data on 12 active sunscreen ingredients, including some of those frequently used in over-the-counter products.

Wavebreakmedia Ltd/Thinkstock

The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.

There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.

OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).

“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”

Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information

Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.

However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said

“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.

In addition to seeking these additional data, the rule also proposes the following:

• Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
• The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
• Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
• New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
• Products that combine sunscreens with insect repellents are not GRASE.

In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”

To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.

msullivan@mdedge.com

The American Academy of Dermatology and the National Psoriasis Foundation have jointly released two new guidelines on the management and treatment of psoriasis with a focus on biologics and comorbidities.

Courtesy National Psoriasis Foundation

These guidelines are the first of two papers to be published in the Journal of the American Academy of Dermatology (JAAD), with four more guidelines on psoriasis to be published later this year in JAAD on phototherapy, topical therapy, nonbiologic systemic medications, and treatment of pediatric patients.

The guideline on biologics updates the 2008 AAD guidelines on psoriasis. In an interview, Alan Menter, MD, cochair of the guidelines work group and lead author of the biologics paper, said the guidelines for biologics were needed because of major advances with the availability of new biologics over the last decade. For example, three tumor necrosis factor–alpha (TNF-alpha) inhibitors were available in 2008, but that number has increased to 10 biologics and now includes agents such as those targeting interleukin (IL)-12/IL-23, IL-17 and IL-23.

In addition, the new guidelines from AAD were developed to represent improvements in the management of patients with moderate to severe psoriasis as well as the relationship between psoriasis and related comorbidities.

“Major advances in new biologic drugs [are] now available to patients, plus [there have been] significant advances in our understanding of comorbid conditions,” such as cardiovascular comorbidities, said Dr. Menter, chairman of the division of dermatology, Baylor University Medical Center, and clinical professor of dermatology, University of Texas, both in Dallas.

The working group for each set of guidelines consisted of dermatologists, patient representatives, a cardiologist, and a rheumatologist. The biologic guidelines working group analyzed studies published between January 2008 and December 2018 and issued a series of recommendations based on published evidence for the effectiveness, adverse events, and switching for Food and Drug Administration–approved TNF-alpha inhibitors (etanercept, infliximab, adalimumab, certolizumab, and TNF-alpha biosimilars); IL-12/IL-23 inhibitors (ustekinumab); IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab); and IL-23 inhibitors (guselkumab and tildrakizumab, and risankizumab, which is still under FDA review) for monotherapy or combination therapy in patients with moderate to severe psoriasis.

“Both the comorbidities guidelines and the biologic guidelines will help educate the psoriasis population with input from dermatologists in clinical practices,” Dr. Menter said.

However, both working groups noted there are still significant gaps in research, such as the effects of treatment combinations for new biologics and the lack of biomarkers that would identify which biologics are best suited for individual psoriasis patients.

There is also little known about the complex relationship between psoriasis and its comorbidities, and how psoriasis treatment can potentially prevent future disease. To ensure treatment of psoriasis-related comorbidities, dermatologists should consider psoriasis as a systemic disease with multiple comorbidities and interact with primary care doctors, cardiologists, and other providers involved in the care of the patients, Dr. Menter said.

There were no specific funding sources reported for the guidelines. Several authors reported relationships with industry, including pharmaceutical companies with drugs and products involving psoriasis, during the development of the guidelines. If a potential conflict was noted, the working group member recused himself or herself from discussion and drafting of recommendations, according to the paper. Dr. Menter’s disclosure includes serving as a consultant, speaker, investigator, and adviser, and receiving honoraria, from multiple pharmaceutical companies.

SOURCE: Menter A et al. J Am Acad Dermatol. 2019 Feb 13. doi: 10.1016/j.jaad.2018.11.057. Elmets CA et al. J Am Acad Dermatol. 2019 Feb 13. doi: 10.1016/j.jaad.2018.11.058.

The American Academy of Dermatology and the National Psoriasis Foundation have jointly released two new guidelines on the management and treatment of psoriasis with a focus on biologics and comorbidities.

Courtesy National Psoriasis Foundation

These guidelines are the first of two papers to be published in the Journal of the American Academy of Dermatology (JAAD), with four more guidelines on psoriasis to be published later this year in JAAD on phototherapy, topical therapy, nonbiologic systemic medications, and treatment of pediatric patients.

The guideline on biologics updates the 2008 AAD guidelines on psoriasis. In an interview, Alan Menter, MD, cochair of the guidelines work group and lead author of the biologics paper, said the guidelines for biologics were needed because of major advances with the availability of new biologics over the last decade. For example, three tumor necrosis factor–alpha (TNF-alpha) inhibitors were available in 2008, but that number has increased to 10 biologics and now includes agents such as those targeting interleukin (IL)-12/IL-23, IL-17 and IL-23.

In addition, the new guidelines from AAD were developed to represent improvements in the management of patients with moderate to severe psoriasis as well as the relationship between psoriasis and related comorbidities.

“Major advances in new biologic drugs [are] now available to patients, plus [there have been] significant advances in our understanding of comorbid conditions,” such as cardiovascular comorbidities, said Dr. Menter, chairman of the division of dermatology, Baylor University Medical Center, and clinical professor of dermatology, University of Texas, both in Dallas.

The working group for each set of guidelines consisted of dermatologists, patient representatives, a cardiologist, and a rheumatologist. The biologic guidelines working group analyzed studies published between January 2008 and December 2018 and issued a series of recommendations based on published evidence for the effectiveness, adverse events, and switching for Food and Drug Administration–approved TNF-alpha inhibitors (etanercept, infliximab, adalimumab, certolizumab, and TNF-alpha biosimilars); IL-12/IL-23 inhibitors (ustekinumab); IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab); and IL-23 inhibitors (guselkumab and tildrakizumab, and risankizumab, which is still under FDA review) for monotherapy or combination therapy in patients with moderate to severe psoriasis.

“Both the comorbidities guidelines and the biologic guidelines will help educate the psoriasis population with input from dermatologists in clinical practices,” Dr. Menter said.

However, both working groups noted there are still significant gaps in research, such as the effects of treatment combinations for new biologics and the lack of biomarkers that would identify which biologics are best suited for individual psoriasis patients.

There is also little known about the complex relationship between psoriasis and its comorbidities, and how psoriasis treatment can potentially prevent future disease. To ensure treatment of psoriasis-related comorbidities, dermatologists should consider psoriasis as a systemic disease with multiple comorbidities and interact with primary care doctors, cardiologists, and other providers involved in the care of the patients, Dr. Menter said.

There were no specific funding sources reported for the guidelines. Several authors reported relationships with industry, including pharmaceutical companies with drugs and products involving psoriasis, during the development of the guidelines. If a potential conflict was noted, the working group member recused himself or herself from discussion and drafting of recommendations, according to the paper. Dr. Menter’s disclosure includes serving as a consultant, speaker, investigator, and adviser, and receiving honoraria, from multiple pharmaceutical companies.

SOURCE: Menter A et al. J Am Acad Dermatol. 2019 Feb 13. doi: 10.1016/j.jaad.2018.11.057. Elmets CA et al. J Am Acad Dermatol. 2019 Feb 13. doi: 10.1016/j.jaad.2018.11.058.

The American Academy of Dermatology and the National Psoriasis Foundation have jointly released two new guidelines on the management and treatment of psoriasis with a focus on biologics and comorbidities.

Courtesy National Psoriasis Foundation

These guidelines are the first of two papers to be published in the Journal of the American Academy of Dermatology (JAAD), with four more guidelines on psoriasis to be published later this year in JAAD on phototherapy, topical therapy, nonbiologic systemic medications, and treatment of pediatric patients.

The guideline on biologics updates the 2008 AAD guidelines on psoriasis. In an interview, Alan Menter, MD, cochair of the guidelines work group and lead author of the biologics paper, said the guidelines for biologics were needed because of major advances with the availability of new biologics over the last decade. For example, three tumor necrosis factor–alpha (TNF-alpha) inhibitors were available in 2008, but that number has increased to 10 biologics and now includes agents such as those targeting interleukin (IL)-12/IL-23, IL-17 and IL-23.

In addition, the new guidelines from AAD were developed to represent improvements in the management of patients with moderate to severe psoriasis as well as the relationship between psoriasis and related comorbidities.

“Major advances in new biologic drugs [are] now available to patients, plus [there have been] significant advances in our understanding of comorbid conditions,” such as cardiovascular comorbidities, said Dr. Menter, chairman of the division of dermatology, Baylor University Medical Center, and clinical professor of dermatology, University of Texas, both in Dallas.

The working group for each set of guidelines consisted of dermatologists, patient representatives, a cardiologist, and a rheumatologist. The biologic guidelines working group analyzed studies published between January 2008 and December 2018 and issued a series of recommendations based on published evidence for the effectiveness, adverse events, and switching for Food and Drug Administration–approved TNF-alpha inhibitors (etanercept, infliximab, adalimumab, certolizumab, and TNF-alpha biosimilars); IL-12/IL-23 inhibitors (ustekinumab); IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab); and IL-23 inhibitors (guselkumab and tildrakizumab, and risankizumab, which is still under FDA review) for monotherapy or combination therapy in patients with moderate to severe psoriasis.

“Both the comorbidities guidelines and the biologic guidelines will help educate the psoriasis population with input from dermatologists in clinical practices,” Dr. Menter said.

However, both working groups noted there are still significant gaps in research, such as the effects of treatment combinations for new biologics and the lack of biomarkers that would identify which biologics are best suited for individual psoriasis patients.

There is also little known about the complex relationship between psoriasis and its comorbidities, and how psoriasis treatment can potentially prevent future disease. To ensure treatment of psoriasis-related comorbidities, dermatologists should consider psoriasis as a systemic disease with multiple comorbidities and interact with primary care doctors, cardiologists, and other providers involved in the care of the patients, Dr. Menter said.

There were no specific funding sources reported for the guidelines. Several authors reported relationships with industry, including pharmaceutical companies with drugs and products involving psoriasis, during the development of the guidelines. If a potential conflict was noted, the working group member recused himself or herself from discussion and drafting of recommendations, according to the paper. Dr. Menter’s disclosure includes serving as a consultant, speaker, investigator, and adviser, and receiving honoraria, from multiple pharmaceutical companies.

SOURCE: Menter A et al. J Am Acad Dermatol. 2019 Feb 13. doi: 10.1016/j.jaad.2018.11.057. Elmets CA et al. J Am Acad Dermatol. 2019 Feb 13. doi: 10.1016/j.jaad.2018.11.058.

A 7-year-old girl’s giant congenital melanocytic nevus (GCMN) was effectively treated with the MEK inhibitor trametinib, according to a case report presented in Pediatrics.

Her nevus covered most of her back and much of her torso and had thickened significantly over the years since initial presentation to the point of disfigurement, even invading the fascia and musculature of the trunk and pelvis, reported Adnan Mir, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, and his coauthors. Furthermore, she presented with intractable pruritus and pain that interfered with sleep and responded minimally to treatments. Although initial immunohistochemical staining and gene sequencing did not reveal any mutations, such as BRAF V600E, further testing uncovered an AKAP9-BRAF fusion.

There are few if any effective ways of treating GCMNs. With that knowledge, as well as general theories of the mechanism GCMNs in mind, the patient’s health care team decided to try a 0.5-mg daily dose of trametinib when she was 7 years old. Her pruritus and pain resolved completely, and after 6 months of treatment with trametinib, repeat MRI “revealed decreased thickening of the dermis and near resolutions of muscular invasion.” According to the patient’s family, her quality of life improved dramatically.

cpalmer@mdedge.com

SOURCE: Mir A et al. Pediatrics. 2019;143(3):e20182469.

A 7-year-old girl’s giant congenital melanocytic nevus (GCMN) was effectively treated with the MEK inhibitor trametinib, according to a case report presented in Pediatrics.

Her nevus covered most of her back and much of her torso and had thickened significantly over the years since initial presentation to the point of disfigurement, even invading the fascia and musculature of the trunk and pelvis, reported Adnan Mir, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, and his coauthors. Furthermore, she presented with intractable pruritus and pain that interfered with sleep and responded minimally to treatments. Although initial immunohistochemical staining and gene sequencing did not reveal any mutations, such as BRAF V600E, further testing uncovered an AKAP9-BRAF fusion.

There are few if any effective ways of treating GCMNs. With that knowledge, as well as general theories of the mechanism GCMNs in mind, the patient’s health care team decided to try a 0.5-mg daily dose of trametinib when she was 7 years old. Her pruritus and pain resolved completely, and after 6 months of treatment with trametinib, repeat MRI “revealed decreased thickening of the dermis and near resolutions of muscular invasion.” According to the patient’s family, her quality of life improved dramatically.

cpalmer@mdedge.com

SOURCE: Mir A et al. Pediatrics. 2019;143(3):e20182469.

A 7-year-old girl’s giant congenital melanocytic nevus (GCMN) was effectively treated with the MEK inhibitor trametinib, according to a case report presented in Pediatrics.

Her nevus covered most of her back and much of her torso and had thickened significantly over the years since initial presentation to the point of disfigurement, even invading the fascia and musculature of the trunk and pelvis, reported Adnan Mir, MD, PhD, of the University of Texas Southwestern Medical Center, Dallas, and his coauthors. Furthermore, she presented with intractable pruritus and pain that interfered with sleep and responded minimally to treatments. Although initial immunohistochemical staining and gene sequencing did not reveal any mutations, such as BRAF V600E, further testing uncovered an AKAP9-BRAF fusion.

There are few if any effective ways of treating GCMNs. With that knowledge, as well as general theories of the mechanism GCMNs in mind, the patient’s health care team decided to try a 0.5-mg daily dose of trametinib when she was 7 years old. Her pruritus and pain resolved completely, and after 6 months of treatment with trametinib, repeat MRI “revealed decreased thickening of the dermis and near resolutions of muscular invasion.” According to the patient’s family, her quality of life improved dramatically.

cpalmer@mdedge.com

SOURCE: Mir A et al. Pediatrics. 2019;143(3):e20182469.

The FP suspected that this was a melanoma or a pigmented basal cell carcinoma.

Going through the ABCDE criteria, the FP noted that the spot was Asymmetric, the Border was irregular, the Colors were varied, the Diameter was >6 mm, and the history was positive for an Enlarging lesion. With 5 out of the 5 criteria positive, it was likely that this was a melanoma. The FP performed a deep shave biopsy (saucerization) with 1- to 2-mm margins to provide full sampling for the pathologist. (See the Watch & Learn video on “Shave biopsy.”) The depth of the tissue biopsy was approximately 1 to 1.5 mm (a dime is 1.4 mm in depth), which was adequate for a lesion of this type. The pathology report came back as invasive melanoma with a 0.25 mm Breslow depth.

The FP referred the patient to a local dermatologist, who agreed to see the patient within the next 2 weeks rather than the standard 3- to 4-month wait time for a new patient. The dermatologist performed a wide local excision with a 1-cm margin down to the fascia. While this melanoma was invasive, this depth did not require sentinel lymph node biopsy for staging. On a follow-up visit, the FP counseled the patient about sun protection and the need for regular skin exams. Note that while brown skin and regular sun exposure may be less risky for melanoma than fair skin with multiple sunburns, anyone can get a melanoma.

‌

Photo courtesy of Eric Kraus, MD and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP suspected that this was a melanoma or a pigmented basal cell carcinoma.

Going through the ABCDE criteria, the FP noted that the spot was Asymmetric, the Border was irregular, the Colors were varied, the Diameter was >6 mm, and the history was positive for an Enlarging lesion. With 5 out of the 5 criteria positive, it was likely that this was a melanoma. The FP performed a deep shave biopsy (saucerization) with 1- to 2-mm margins to provide full sampling for the pathologist. (See the Watch & Learn video on “Shave biopsy.”) The depth of the tissue biopsy was approximately 1 to 1.5 mm (a dime is 1.4 mm in depth), which was adequate for a lesion of this type. The pathology report came back as invasive melanoma with a 0.25 mm Breslow depth.

The FP referred the patient to a local dermatologist, who agreed to see the patient within the next 2 weeks rather than the standard 3- to 4-month wait time for a new patient. The dermatologist performed a wide local excision with a 1-cm margin down to the fascia. While this melanoma was invasive, this depth did not require sentinel lymph node biopsy for staging. On a follow-up visit, the FP counseled the patient about sun protection and the need for regular skin exams. Note that while brown skin and regular sun exposure may be less risky for melanoma than fair skin with multiple sunburns, anyone can get a melanoma.

‌

Photo courtesy of Eric Kraus, MD and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP suspected that this was a melanoma or a pigmented basal cell carcinoma.

Going through the ABCDE criteria, the FP noted that the spot was Asymmetric, the Border was irregular, the Colors were varied, the Diameter was >6 mm, and the history was positive for an Enlarging lesion. With 5 out of the 5 criteria positive, it was likely that this was a melanoma. The FP performed a deep shave biopsy (saucerization) with 1- to 2-mm margins to provide full sampling for the pathologist. (See the Watch & Learn video on “Shave biopsy.”) The depth of the tissue biopsy was approximately 1 to 1.5 mm (a dime is 1.4 mm in depth), which was adequate for a lesion of this type. The pathology report came back as invasive melanoma with a 0.25 mm Breslow depth.

The FP referred the patient to a local dermatologist, who agreed to see the patient within the next 2 weeks rather than the standard 3- to 4-month wait time for a new patient. The dermatologist performed a wide local excision with a 1-cm margin down to the fascia. While this melanoma was invasive, this depth did not require sentinel lymph node biopsy for staging. On a follow-up visit, the FP counseled the patient about sun protection and the need for regular skin exams. Note that while brown skin and regular sun exposure may be less risky for melanoma than fair skin with multiple sunburns, anyone can get a melanoma.

‌

Photo courtesy of Eric Kraus, MD and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com