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Systematic review of radiofrequency microneedling studies unveiled
Of the according to results from a new systematic review.
“Most devices for aesthetic purposes induce denaturation and remodeling of collagen, elastin, and other dermal structures through tissue injury and stimulating the body’s wound-healing response,” lead study author Marcus G. Tan, MD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “Radiofrequency microneedling is no exception in this regard. RFMN creates perforations in the skin and delivers radiofrequency-generated thermal energy into the underlying tissue. However, RFMN is unique in that thermal energy is delivered in a fashion that produces a reverse temperature gradient to most ablative lasers.”
When using ablative lasers, which target water as its chromophore through selective photothermolysis, the temperature gradient is highest at the epidermis and papillary dermis, and decreases as it penetrates the deeper structures of the skin. In RFMN, radiofrequency energy is delivered directly to the target depth through the microneedle electrodes, thus creating a temperature gradient that is highest in the deep, target structures and cooler at the superficial structures. “This results in less unwanted epidermal heating and reduces the risk of postinflammatory hyperpigmentation,” explained Dr. Tan, a resident in the division of dermatology at the University of Ottawa.
“Because RFMN is unaffected by skin chromophores, it is essentially a ‘color-blind’ technology and safe for use in patients of all skin phototypes. In comparison to lasers, radiofrequency energy can also be delivered to deeper structures of the skin by increasing the length of microneedle electrodes. Despite these advantages of RFMN, this technology remains utilized less frequently compared to ablative lasers for its skin rejuvenating effects.”
To review high-quality medical literature related to RFMN, Dr. Tan and colleagues searched EMBASE and MEDLINE from inception to May 13, 2020, by using the terms “radiofrequency microneedling,” “fractional radiofrequency,” “radiofrequency needling,” or “radiofrequency percutaneous collagen induction.” They limited the analysis to dermatology-related randomized, split-body, or blinded studies with original data in humans. Of the 42 studies included in the final analysis, there were 14 studies of skin rejuvenation, 7 of acne scars, 6 of acne vulgaris, 5 each of striae and axillary hyperhidrosis, 2 of melasma, and 1 each of rosacea, cellulite, and androgenetic alopecia.
After reviewing the 42 studies, the study authors proposed that a strong recommendation for RFMN be made for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis, and a weak recommendation for the technology to be used for papulopustular rosacea, striae, and male-pattern androgenetic alopecia when used in conjunction with topical 5% minoxidil. There was insufficient evidence to make recommendations for its use in cellulite and melasma.
One finding that Dr. Tan described as “interesting” was the observation that RFMN was superior to Er:YAG fractional ablative lasers for treatment of rhytides on the lower face (i.e., the nasolabial, perioral, jawline and neck regions). “Secondly, we observed that one session of RFMN was able to achieve 37% efficacy of a surgical face-lift, but without any adverse effects,” Dr. Tan said. “Two-thirds of the patients who received surgical face-lift developed hypertrophic scarring requiring further scar management, compared to none of the patients receiving RFMN.”
Based on their review, Dr. Tan and colleagues recommend that RFMN be offered as one of the therapeutic options for patients seeking treatment for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis. “It is usually tolerable with just topical anesthesia applied 30-60 minutes before treatment, and its side effects are transient and usually resolve after 5 days,” he said. “Patients should be counseled that the benefits of RFMN may have a slower onset, compared to other treatments, but it is progressive, durable, and can be used repeatedly and safely in all skin types including darker-skin phenotypes with minimal risk of adverse events.”
One of the abstract section chairs, Fernanda H. Sakamoto, MD, PhD, said that RFMN devices have become increasingly popular in recent years. “The paper presented by Tan et al. is very relevant, as it compares clinical indications, parameters, and results in search for evidence of efficacy and appropriate settings,” said Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, told this news organization. “The paper provides long-needed guidelines to clinicians and helps manage patients’ expectations.”
Dr. Tan acknowledged certain limitations of the study, including the lack of head-to-head studies comparing specific RFMN devices. “There are many RFMN devices available commercially, each with different capabilities and degrees of effectiveness,” he said. “With more research and technological advancements since the first radiofrequency device was approved in 2002, RFMN has made significant improvements. In general, the newer generation devices produce markedly better results.”
Dr. Tan reported having no financial disclosures. Dr. Sakamoto disclosed that she holds intellectual property rights with Accure Acne, Massachusetts General Hospital, and Lightwater Biosciences.
Of the according to results from a new systematic review.
“Most devices for aesthetic purposes induce denaturation and remodeling of collagen, elastin, and other dermal structures through tissue injury and stimulating the body’s wound-healing response,” lead study author Marcus G. Tan, MD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “Radiofrequency microneedling is no exception in this regard. RFMN creates perforations in the skin and delivers radiofrequency-generated thermal energy into the underlying tissue. However, RFMN is unique in that thermal energy is delivered in a fashion that produces a reverse temperature gradient to most ablative lasers.”
When using ablative lasers, which target water as its chromophore through selective photothermolysis, the temperature gradient is highest at the epidermis and papillary dermis, and decreases as it penetrates the deeper structures of the skin. In RFMN, radiofrequency energy is delivered directly to the target depth through the microneedle electrodes, thus creating a temperature gradient that is highest in the deep, target structures and cooler at the superficial structures. “This results in less unwanted epidermal heating and reduces the risk of postinflammatory hyperpigmentation,” explained Dr. Tan, a resident in the division of dermatology at the University of Ottawa.
“Because RFMN is unaffected by skin chromophores, it is essentially a ‘color-blind’ technology and safe for use in patients of all skin phototypes. In comparison to lasers, radiofrequency energy can also be delivered to deeper structures of the skin by increasing the length of microneedle electrodes. Despite these advantages of RFMN, this technology remains utilized less frequently compared to ablative lasers for its skin rejuvenating effects.”
To review high-quality medical literature related to RFMN, Dr. Tan and colleagues searched EMBASE and MEDLINE from inception to May 13, 2020, by using the terms “radiofrequency microneedling,” “fractional radiofrequency,” “radiofrequency needling,” or “radiofrequency percutaneous collagen induction.” They limited the analysis to dermatology-related randomized, split-body, or blinded studies with original data in humans. Of the 42 studies included in the final analysis, there were 14 studies of skin rejuvenation, 7 of acne scars, 6 of acne vulgaris, 5 each of striae and axillary hyperhidrosis, 2 of melasma, and 1 each of rosacea, cellulite, and androgenetic alopecia.
After reviewing the 42 studies, the study authors proposed that a strong recommendation for RFMN be made for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis, and a weak recommendation for the technology to be used for papulopustular rosacea, striae, and male-pattern androgenetic alopecia when used in conjunction with topical 5% minoxidil. There was insufficient evidence to make recommendations for its use in cellulite and melasma.
One finding that Dr. Tan described as “interesting” was the observation that RFMN was superior to Er:YAG fractional ablative lasers for treatment of rhytides on the lower face (i.e., the nasolabial, perioral, jawline and neck regions). “Secondly, we observed that one session of RFMN was able to achieve 37% efficacy of a surgical face-lift, but without any adverse effects,” Dr. Tan said. “Two-thirds of the patients who received surgical face-lift developed hypertrophic scarring requiring further scar management, compared to none of the patients receiving RFMN.”
Based on their review, Dr. Tan and colleagues recommend that RFMN be offered as one of the therapeutic options for patients seeking treatment for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis. “It is usually tolerable with just topical anesthesia applied 30-60 minutes before treatment, and its side effects are transient and usually resolve after 5 days,” he said. “Patients should be counseled that the benefits of RFMN may have a slower onset, compared to other treatments, but it is progressive, durable, and can be used repeatedly and safely in all skin types including darker-skin phenotypes with minimal risk of adverse events.”
One of the abstract section chairs, Fernanda H. Sakamoto, MD, PhD, said that RFMN devices have become increasingly popular in recent years. “The paper presented by Tan et al. is very relevant, as it compares clinical indications, parameters, and results in search for evidence of efficacy and appropriate settings,” said Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, told this news organization. “The paper provides long-needed guidelines to clinicians and helps manage patients’ expectations.”
Dr. Tan acknowledged certain limitations of the study, including the lack of head-to-head studies comparing specific RFMN devices. “There are many RFMN devices available commercially, each with different capabilities and degrees of effectiveness,” he said. “With more research and technological advancements since the first radiofrequency device was approved in 2002, RFMN has made significant improvements. In general, the newer generation devices produce markedly better results.”
Dr. Tan reported having no financial disclosures. Dr. Sakamoto disclosed that she holds intellectual property rights with Accure Acne, Massachusetts General Hospital, and Lightwater Biosciences.
Of the according to results from a new systematic review.
“Most devices for aesthetic purposes induce denaturation and remodeling of collagen, elastin, and other dermal structures through tissue injury and stimulating the body’s wound-healing response,” lead study author Marcus G. Tan, MD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “Radiofrequency microneedling is no exception in this regard. RFMN creates perforations in the skin and delivers radiofrequency-generated thermal energy into the underlying tissue. However, RFMN is unique in that thermal energy is delivered in a fashion that produces a reverse temperature gradient to most ablative lasers.”
When using ablative lasers, which target water as its chromophore through selective photothermolysis, the temperature gradient is highest at the epidermis and papillary dermis, and decreases as it penetrates the deeper structures of the skin. In RFMN, radiofrequency energy is delivered directly to the target depth through the microneedle electrodes, thus creating a temperature gradient that is highest in the deep, target structures and cooler at the superficial structures. “This results in less unwanted epidermal heating and reduces the risk of postinflammatory hyperpigmentation,” explained Dr. Tan, a resident in the division of dermatology at the University of Ottawa.
“Because RFMN is unaffected by skin chromophores, it is essentially a ‘color-blind’ technology and safe for use in patients of all skin phototypes. In comparison to lasers, radiofrequency energy can also be delivered to deeper structures of the skin by increasing the length of microneedle electrodes. Despite these advantages of RFMN, this technology remains utilized less frequently compared to ablative lasers for its skin rejuvenating effects.”
To review high-quality medical literature related to RFMN, Dr. Tan and colleagues searched EMBASE and MEDLINE from inception to May 13, 2020, by using the terms “radiofrequency microneedling,” “fractional radiofrequency,” “radiofrequency needling,” or “radiofrequency percutaneous collagen induction.” They limited the analysis to dermatology-related randomized, split-body, or blinded studies with original data in humans. Of the 42 studies included in the final analysis, there were 14 studies of skin rejuvenation, 7 of acne scars, 6 of acne vulgaris, 5 each of striae and axillary hyperhidrosis, 2 of melasma, and 1 each of rosacea, cellulite, and androgenetic alopecia.
After reviewing the 42 studies, the study authors proposed that a strong recommendation for RFMN be made for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis, and a weak recommendation for the technology to be used for papulopustular rosacea, striae, and male-pattern androgenetic alopecia when used in conjunction with topical 5% minoxidil. There was insufficient evidence to make recommendations for its use in cellulite and melasma.
One finding that Dr. Tan described as “interesting” was the observation that RFMN was superior to Er:YAG fractional ablative lasers for treatment of rhytides on the lower face (i.e., the nasolabial, perioral, jawline and neck regions). “Secondly, we observed that one session of RFMN was able to achieve 37% efficacy of a surgical face-lift, but without any adverse effects,” Dr. Tan said. “Two-thirds of the patients who received surgical face-lift developed hypertrophic scarring requiring further scar management, compared to none of the patients receiving RFMN.”
Based on their review, Dr. Tan and colleagues recommend that RFMN be offered as one of the therapeutic options for patients seeking treatment for skin rejuvenation, acne vulgaris, acne scars, and axillary hyperhidrosis. “It is usually tolerable with just topical anesthesia applied 30-60 minutes before treatment, and its side effects are transient and usually resolve after 5 days,” he said. “Patients should be counseled that the benefits of RFMN may have a slower onset, compared to other treatments, but it is progressive, durable, and can be used repeatedly and safely in all skin types including darker-skin phenotypes with minimal risk of adverse events.”
One of the abstract section chairs, Fernanda H. Sakamoto, MD, PhD, said that RFMN devices have become increasingly popular in recent years. “The paper presented by Tan et al. is very relevant, as it compares clinical indications, parameters, and results in search for evidence of efficacy and appropriate settings,” said Dr. Sakamoto, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, told this news organization. “The paper provides long-needed guidelines to clinicians and helps manage patients’ expectations.”
Dr. Tan acknowledged certain limitations of the study, including the lack of head-to-head studies comparing specific RFMN devices. “There are many RFMN devices available commercially, each with different capabilities and degrees of effectiveness,” he said. “With more research and technological advancements since the first radiofrequency device was approved in 2002, RFMN has made significant improvements. In general, the newer generation devices produce markedly better results.”
Dr. Tan reported having no financial disclosures. Dr. Sakamoto disclosed that she holds intellectual property rights with Accure Acne, Massachusetts General Hospital, and Lightwater Biosciences.
FROM ASLMS 2021
Photobiomodulation reduced acute radiodermatitis severity in head and neck cancer patients
The delivery of , according to results from the first randomized study of its kind.
“The use of light therapy-based applications for cancer therapy-related adverse events has steadily increased in the past 40 years,” lead study author Jolien Robijns, MSc, PhD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “The most well-known and studied indication of photobiomodulation therapy in supportive cancer care is oral mucositis,” she said, referring to a recent systematic review, which found that based on the available evidence, PBMT is an effective therapy for the prevention of oral mucositis, using well-defined PBM parameters in specific patient populations. “Various internationally well-recognized health organizations in oncology recommend PBMT to prevent and manage oral mucositis,” she added.
Based on the wound-healing and anti-inflammatory properties of PBMT, several studies have investigated its use for the prevention and management of acute radiodermatitis (ARD) since the 1990s, said Dr. Robijns, a postdoctoral researcher at Limburg Clinical Research Center in Hasselt, Belgium. Under the supervision of Jeroen Mebis, MD, PhD, at the Limburg Oncologic Laser Institute, she and her colleagues have been conducting clinical research on PBMT and ARD since 2014, with successful results. In 2020 they published a narrative review, which showed that based on nine clinical trials, PBMT could effectively reduce the incidence of severe ARD, decrease accompanying pain, and improve patients’ quality of life.
For the current study, known as the DERMISHEAD trial and published online March 9, 2021, in Radiotherapy and Oncology, investigators at Limburg Oncology Center at Jessa Hospital in Hasselt, and Hasselt University, recruited head and neck cancer patients who underwent bilateral radiotherapy with or without chemotherapy, for a total dose of 30-35 x 2 Gy . All patients received standard skin care combined with two PBMT or sham sessions twice per week during the complete course of RT, which resulted in 14 total sessions.
As described in the Radiotherapy and Oncology study, the commercially available device used for PBMT “consists of two laser diodes with different wavelengths (808-905 nm), peak powers (1.1-25 W), and emission modes (continuous and pulsed). Both diodes work simultaneously and synchronously with coincident propagation axes (average radiant power 3.3 W). The energy density (fluence) was set at 4 J/cm2 based on earlier recommendations and on our clinical experience.” A blinded study nurse used Radiation Therapy Oncology Group criteria to evaluate the skin reactions.
After 303 patients were initially assessed for eligibility, 46 patients were enrolled in DERMISHEAD (18 in the placebo group and 28 in the PBMT group). At the end of radiotherapy, 77.8% of patients in the placebo group had a grade 2 or 3 skin reaction, compared with 28.6% of patients in the PBMT group (P = .001).
“The DERMISHEAD trial proved that PBMT significantly reduces the severity of ARD,” Dr. Robijns said. “Thereby, it improves the patients’ quality of life during their radiotherapy course. The trial supports the further implementation of PBM in the supportive care of cancer patients undergoing radiotherapy.”
The results are similar to those in the TRANSDERMIS trial, in which Dr. Robijns and her colleagues used PMBT to treat breast cancer patients.
“However, an interesting difference is that the percentage decrease in severe ARD was higher in the DERMISHEAD trial than in the TRANSDERMIS trial: 49% vs. 23%, respectively,” she noted. “This difference can be rationalized because in total, more control head and neck cancer patients developed grade 3 ARD than did control breast cancer patients (17% vs. 5%). A possible explanation of this finding can be related to the difference in treatment regimens and radiotherapy parameters between the two trials.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was asked to comment on the study, said that acute radiation dermatitis “can be very painful and distressing to patients, and over time, the skin changes can create long-term problems. Prevention of acute and chronic radiation dermatitis is worthwhile, particularly for patients at risk.”
This study, she added, “shows a benefit of photobiomodulation therapy as a potential preventative treatment. Notably, patients did not always follow up appropriately for the therapy, and the authors said that it is yet another thing that patients need to keep track of, in addition to their cancer therapy visits. Thus, optimally, it would be useful to have a biomarker of which patients would most benefit from treatments that prevent/potentiate radiation dermatitis.”
Dr. Robijns acknowledged certain limitations of the trial, including its small sample size and the scarcity of clinical trials on PBM and acute radiation dermatitis. “More studies are needed,” she said. “Future studies should focus on randomized controlled study designs with well-described and complete PBMT parameters in a larger and more diverse patient population. This would enable the implementation of PBM in the field of ARD and supportive cancer care, which would enhance wound care management and improve the patient’s quality of life.”
This work won a “best of clinical applications” abstract award from the ASLMS.
The research is part of the Limburg Clinical Research Center UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish Government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. The research is also funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society, Limburgs Kankerfonds, and ASA Srl. Dr. Robijns reported having no financial disclosures.
The delivery of , according to results from the first randomized study of its kind.
“The use of light therapy-based applications for cancer therapy-related adverse events has steadily increased in the past 40 years,” lead study author Jolien Robijns, MSc, PhD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “The most well-known and studied indication of photobiomodulation therapy in supportive cancer care is oral mucositis,” she said, referring to a recent systematic review, which found that based on the available evidence, PBMT is an effective therapy for the prevention of oral mucositis, using well-defined PBM parameters in specific patient populations. “Various internationally well-recognized health organizations in oncology recommend PBMT to prevent and manage oral mucositis,” she added.
Based on the wound-healing and anti-inflammatory properties of PBMT, several studies have investigated its use for the prevention and management of acute radiodermatitis (ARD) since the 1990s, said Dr. Robijns, a postdoctoral researcher at Limburg Clinical Research Center in Hasselt, Belgium. Under the supervision of Jeroen Mebis, MD, PhD, at the Limburg Oncologic Laser Institute, she and her colleagues have been conducting clinical research on PBMT and ARD since 2014, with successful results. In 2020 they published a narrative review, which showed that based on nine clinical trials, PBMT could effectively reduce the incidence of severe ARD, decrease accompanying pain, and improve patients’ quality of life.
For the current study, known as the DERMISHEAD trial and published online March 9, 2021, in Radiotherapy and Oncology, investigators at Limburg Oncology Center at Jessa Hospital in Hasselt, and Hasselt University, recruited head and neck cancer patients who underwent bilateral radiotherapy with or without chemotherapy, for a total dose of 30-35 x 2 Gy . All patients received standard skin care combined with two PBMT or sham sessions twice per week during the complete course of RT, which resulted in 14 total sessions.
As described in the Radiotherapy and Oncology study, the commercially available device used for PBMT “consists of two laser diodes with different wavelengths (808-905 nm), peak powers (1.1-25 W), and emission modes (continuous and pulsed). Both diodes work simultaneously and synchronously with coincident propagation axes (average radiant power 3.3 W). The energy density (fluence) was set at 4 J/cm2 based on earlier recommendations and on our clinical experience.” A blinded study nurse used Radiation Therapy Oncology Group criteria to evaluate the skin reactions.
After 303 patients were initially assessed for eligibility, 46 patients were enrolled in DERMISHEAD (18 in the placebo group and 28 in the PBMT group). At the end of radiotherapy, 77.8% of patients in the placebo group had a grade 2 or 3 skin reaction, compared with 28.6% of patients in the PBMT group (P = .001).
“The DERMISHEAD trial proved that PBMT significantly reduces the severity of ARD,” Dr. Robijns said. “Thereby, it improves the patients’ quality of life during their radiotherapy course. The trial supports the further implementation of PBM in the supportive care of cancer patients undergoing radiotherapy.”
The results are similar to those in the TRANSDERMIS trial, in which Dr. Robijns and her colleagues used PMBT to treat breast cancer patients.
“However, an interesting difference is that the percentage decrease in severe ARD was higher in the DERMISHEAD trial than in the TRANSDERMIS trial: 49% vs. 23%, respectively,” she noted. “This difference can be rationalized because in total, more control head and neck cancer patients developed grade 3 ARD than did control breast cancer patients (17% vs. 5%). A possible explanation of this finding can be related to the difference in treatment regimens and radiotherapy parameters between the two trials.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was asked to comment on the study, said that acute radiation dermatitis “can be very painful and distressing to patients, and over time, the skin changes can create long-term problems. Prevention of acute and chronic radiation dermatitis is worthwhile, particularly for patients at risk.”
This study, she added, “shows a benefit of photobiomodulation therapy as a potential preventative treatment. Notably, patients did not always follow up appropriately for the therapy, and the authors said that it is yet another thing that patients need to keep track of, in addition to their cancer therapy visits. Thus, optimally, it would be useful to have a biomarker of which patients would most benefit from treatments that prevent/potentiate radiation dermatitis.”
Dr. Robijns acknowledged certain limitations of the trial, including its small sample size and the scarcity of clinical trials on PBM and acute radiation dermatitis. “More studies are needed,” she said. “Future studies should focus on randomized controlled study designs with well-described and complete PBMT parameters in a larger and more diverse patient population. This would enable the implementation of PBM in the field of ARD and supportive cancer care, which would enhance wound care management and improve the patient’s quality of life.”
This work won a “best of clinical applications” abstract award from the ASLMS.
The research is part of the Limburg Clinical Research Center UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish Government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. The research is also funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society, Limburgs Kankerfonds, and ASA Srl. Dr. Robijns reported having no financial disclosures.
The delivery of , according to results from the first randomized study of its kind.
“The use of light therapy-based applications for cancer therapy-related adverse events has steadily increased in the past 40 years,” lead study author Jolien Robijns, MSc, PhD, told this news organization during the annual conference of the American Society for Laser Medicine and Surgery. “The most well-known and studied indication of photobiomodulation therapy in supportive cancer care is oral mucositis,” she said, referring to a recent systematic review, which found that based on the available evidence, PBMT is an effective therapy for the prevention of oral mucositis, using well-defined PBM parameters in specific patient populations. “Various internationally well-recognized health organizations in oncology recommend PBMT to prevent and manage oral mucositis,” she added.
Based on the wound-healing and anti-inflammatory properties of PBMT, several studies have investigated its use for the prevention and management of acute radiodermatitis (ARD) since the 1990s, said Dr. Robijns, a postdoctoral researcher at Limburg Clinical Research Center in Hasselt, Belgium. Under the supervision of Jeroen Mebis, MD, PhD, at the Limburg Oncologic Laser Institute, she and her colleagues have been conducting clinical research on PBMT and ARD since 2014, with successful results. In 2020 they published a narrative review, which showed that based on nine clinical trials, PBMT could effectively reduce the incidence of severe ARD, decrease accompanying pain, and improve patients’ quality of life.
For the current study, known as the DERMISHEAD trial and published online March 9, 2021, in Radiotherapy and Oncology, investigators at Limburg Oncology Center at Jessa Hospital in Hasselt, and Hasselt University, recruited head and neck cancer patients who underwent bilateral radiotherapy with or without chemotherapy, for a total dose of 30-35 x 2 Gy . All patients received standard skin care combined with two PBMT or sham sessions twice per week during the complete course of RT, which resulted in 14 total sessions.
As described in the Radiotherapy and Oncology study, the commercially available device used for PBMT “consists of two laser diodes with different wavelengths (808-905 nm), peak powers (1.1-25 W), and emission modes (continuous and pulsed). Both diodes work simultaneously and synchronously with coincident propagation axes (average radiant power 3.3 W). The energy density (fluence) was set at 4 J/cm2 based on earlier recommendations and on our clinical experience.” A blinded study nurse used Radiation Therapy Oncology Group criteria to evaluate the skin reactions.
After 303 patients were initially assessed for eligibility, 46 patients were enrolled in DERMISHEAD (18 in the placebo group and 28 in the PBMT group). At the end of radiotherapy, 77.8% of patients in the placebo group had a grade 2 or 3 skin reaction, compared with 28.6% of patients in the PBMT group (P = .001).
“The DERMISHEAD trial proved that PBMT significantly reduces the severity of ARD,” Dr. Robijns said. “Thereby, it improves the patients’ quality of life during their radiotherapy course. The trial supports the further implementation of PBM in the supportive care of cancer patients undergoing radiotherapy.”
The results are similar to those in the TRANSDERMIS trial, in which Dr. Robijns and her colleagues used PMBT to treat breast cancer patients.
“However, an interesting difference is that the percentage decrease in severe ARD was higher in the DERMISHEAD trial than in the TRANSDERMIS trial: 49% vs. 23%, respectively,” she noted. “This difference can be rationalized because in total, more control head and neck cancer patients developed grade 3 ARD than did control breast cancer patients (17% vs. 5%). A possible explanation of this finding can be related to the difference in treatment regimens and radiotherapy parameters between the two trials.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was asked to comment on the study, said that acute radiation dermatitis “can be very painful and distressing to patients, and over time, the skin changes can create long-term problems. Prevention of acute and chronic radiation dermatitis is worthwhile, particularly for patients at risk.”
This study, she added, “shows a benefit of photobiomodulation therapy as a potential preventative treatment. Notably, patients did not always follow up appropriately for the therapy, and the authors said that it is yet another thing that patients need to keep track of, in addition to their cancer therapy visits. Thus, optimally, it would be useful to have a biomarker of which patients would most benefit from treatments that prevent/potentiate radiation dermatitis.”
Dr. Robijns acknowledged certain limitations of the trial, including its small sample size and the scarcity of clinical trials on PBM and acute radiation dermatitis. “More studies are needed,” she said. “Future studies should focus on randomized controlled study designs with well-described and complete PBMT parameters in a larger and more diverse patient population. This would enable the implementation of PBM in the field of ARD and supportive cancer care, which would enhance wound care management and improve the patient’s quality of life.”
This work won a “best of clinical applications” abstract award from the ASLMS.
The research is part of the Limburg Clinical Research Center UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish Government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. The research is also funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society, Limburgs Kankerfonds, and ASA Srl. Dr. Robijns reported having no financial disclosures.
FROM ASLMS 2021