Patrice Wendling

CHICAGO — The future of psoriasis therapy lies in oral therapies now in development, Neil J. Korman, M.D., reported at the 11th International Psoriasis Symposium sponsored by the Skin Disease Education Foundation.

“Biologics have made an enormous difference in people's lives, but if you ask a patient if they want a shot or a pill, we all know the answer to that question,” Dr. Korman said.

The new drugs in development fall into two categories: drugs that target interleukin-12 and interleukin-23, and orally available small-molecule therapies.

In humans, IL-12 mRNA has been detected in psoriatic plaques but not in normal skin. Immunoreactivity for IL-12 is also increased in psoriatic plaques.

Investigators at Centocor have developed a fully human monoclonal IL-12 antibody, CNTO 1275, that demonstrated “a low placebo response and a very beautiful dose-response curve” in an ongoing phase II trial, said Dr. Korman of Case Western Reserve University, Cleveland.

A total of 252 patients were treated with a single dose of 50 mg or 100 mg, or a weekly dosage of 50 mg or 100 mg for 4 weeks. The primary end point of a 75% or greater improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12 was achieved by 52%, 59%, 67%, and 81% of patients in the four treatment groups, respectively. In contrast, only 1.6% of the 67 placebo-treated patients achieved a PASI 75.

At week 20, there was no significant difference in safety data between any of the groups, he said.

Two phase II psoriasis studies are now underway to evaluate STA-5326, an orally available small molecule that inhibits production of IL-12 and IL-23. The molecule was discovered and is being developed by Synta Pharmaceuticals.

An oral formulation of pimecrolimus has been developed by Novartis and studied in 143 patients with moderate to severe chronic plaque psoriasis in a randomized, double-blind phase II trial.

At week 13, the median change in PASI scores from baseline was about 85% in patients treated with 30 mg twice daily for 12 weeks.

One safety finding is that patients reported a warm sensation when taking oral pimecrolimus and increased GI disorders, including diarrhea and nausea, which appear to be dose dependent, he said.

In the same category is ISA 247, a novel calcineurin inhibitor developed by Isotechnika, which is structurally similar to cyclosporine and is three times more potent than cyclosporine in vitro. In a phase II study, about 74% of patients given 0.75 mg/kg twice daily for 12 weeks achieved a PASI 75 response. The incidence of hypertension was lower than in previously reported trials of cyclosporine.

Early data from an ongoing phase III study in Canada showed that only 4.4% of 453 patients treated with ISA 247 had more than a 30% increase in creatinine. This compares very favorably with creatinine elevations reported with cyclosporine, suggesting that ISA 247 is safer than cyclosporine, he said.

Finally, Biogen Idec Inc. has developed BG-12, a more efficacious and tolerable oral formulation of fumaric acid esters that will be entering phase III trials in the United States. Fumaric acid esters have been used successfully for decades in Germany to treat psoriasis, but GI side effects have limited their use.

Dr. Korman has received funding from Centocor, Novartis, and Synta.

The SDEF and this newspaper are wholly owned subsidiaries of Elsevier.

CHICAGO — The future of psoriasis therapy lies in oral therapies now in development, Neil J. Korman, M.D., reported at the 11th International Psoriasis Symposium sponsored by the Skin Disease Education Foundation.

“Biologics have made an enormous difference in people's lives, but if you ask a patient if they want a shot or a pill, we all know the answer to that question,” Dr. Korman said.

The new drugs in development fall into two categories: drugs that target interleukin-12 and interleukin-23, and orally available small-molecule therapies.

In humans, IL-12 mRNA has been detected in psoriatic plaques but not in normal skin. Immunoreactivity for IL-12 is also increased in psoriatic plaques.

Investigators at Centocor have developed a fully human monoclonal IL-12 antibody, CNTO 1275, that demonstrated “a low placebo response and a very beautiful dose-response curve” in an ongoing phase II trial, said Dr. Korman of Case Western Reserve University, Cleveland.

A total of 252 patients were treated with a single dose of 50 mg or 100 mg, or a weekly dosage of 50 mg or 100 mg for 4 weeks. The primary end point of a 75% or greater improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12 was achieved by 52%, 59%, 67%, and 81% of patients in the four treatment groups, respectively. In contrast, only 1.6% of the 67 placebo-treated patients achieved a PASI 75.

At week 20, there was no significant difference in safety data between any of the groups, he said.

Two phase II psoriasis studies are now underway to evaluate STA-5326, an orally available small molecule that inhibits production of IL-12 and IL-23. The molecule was discovered and is being developed by Synta Pharmaceuticals.

An oral formulation of pimecrolimus has been developed by Novartis and studied in 143 patients with moderate to severe chronic plaque psoriasis in a randomized, double-blind phase II trial.

At week 13, the median change in PASI scores from baseline was about 85% in patients treated with 30 mg twice daily for 12 weeks.

One safety finding is that patients reported a warm sensation when taking oral pimecrolimus and increased GI disorders, including diarrhea and nausea, which appear to be dose dependent, he said.

In the same category is ISA 247, a novel calcineurin inhibitor developed by Isotechnika, which is structurally similar to cyclosporine and is three times more potent than cyclosporine in vitro. In a phase II study, about 74% of patients given 0.75 mg/kg twice daily for 12 weeks achieved a PASI 75 response. The incidence of hypertension was lower than in previously reported trials of cyclosporine.

Early data from an ongoing phase III study in Canada showed that only 4.4% of 453 patients treated with ISA 247 had more than a 30% increase in creatinine. This compares very favorably with creatinine elevations reported with cyclosporine, suggesting that ISA 247 is safer than cyclosporine, he said.

Finally, Biogen Idec Inc. has developed BG-12, a more efficacious and tolerable oral formulation of fumaric acid esters that will be entering phase III trials in the United States. Fumaric acid esters have been used successfully for decades in Germany to treat psoriasis, but GI side effects have limited their use.

Dr. Korman has received funding from Centocor, Novartis, and Synta.

The SDEF and this newspaper are wholly owned subsidiaries of Elsevier.

CHICAGO — The future of psoriasis therapy lies in oral therapies now in development, Neil J. Korman, M.D., reported at the 11th International Psoriasis Symposium sponsored by the Skin Disease Education Foundation.

“Biologics have made an enormous difference in people's lives, but if you ask a patient if they want a shot or a pill, we all know the answer to that question,” Dr. Korman said.

The new drugs in development fall into two categories: drugs that target interleukin-12 and interleukin-23, and orally available small-molecule therapies.

In humans, IL-12 mRNA has been detected in psoriatic plaques but not in normal skin. Immunoreactivity for IL-12 is also increased in psoriatic plaques.

Investigators at Centocor have developed a fully human monoclonal IL-12 antibody, CNTO 1275, that demonstrated “a low placebo response and a very beautiful dose-response curve” in an ongoing phase II trial, said Dr. Korman of Case Western Reserve University, Cleveland.

A total of 252 patients were treated with a single dose of 50 mg or 100 mg, or a weekly dosage of 50 mg or 100 mg for 4 weeks. The primary end point of a 75% or greater improvement in the Psoriasis Area and Severity Index (PASI 75) at week 12 was achieved by 52%, 59%, 67%, and 81% of patients in the four treatment groups, respectively. In contrast, only 1.6% of the 67 placebo-treated patients achieved a PASI 75.

At week 20, there was no significant difference in safety data between any of the groups, he said.

Two phase II psoriasis studies are now underway to evaluate STA-5326, an orally available small molecule that inhibits production of IL-12 and IL-23. The molecule was discovered and is being developed by Synta Pharmaceuticals.

An oral formulation of pimecrolimus has been developed by Novartis and studied in 143 patients with moderate to severe chronic plaque psoriasis in a randomized, double-blind phase II trial.

At week 13, the median change in PASI scores from baseline was about 85% in patients treated with 30 mg twice daily for 12 weeks.

One safety finding is that patients reported a warm sensation when taking oral pimecrolimus and increased GI disorders, including diarrhea and nausea, which appear to be dose dependent, he said.

In the same category is ISA 247, a novel calcineurin inhibitor developed by Isotechnika, which is structurally similar to cyclosporine and is three times more potent than cyclosporine in vitro. In a phase II study, about 74% of patients given 0.75 mg/kg twice daily for 12 weeks achieved a PASI 75 response. The incidence of hypertension was lower than in previously reported trials of cyclosporine.

Early data from an ongoing phase III study in Canada showed that only 4.4% of 453 patients treated with ISA 247 had more than a 30% increase in creatinine. This compares very favorably with creatinine elevations reported with cyclosporine, suggesting that ISA 247 is safer than cyclosporine, he said.

Finally, Biogen Idec Inc. has developed BG-12, a more efficacious and tolerable oral formulation of fumaric acid esters that will be entering phase III trials in the United States. Fumaric acid esters have been used successfully for decades in Germany to treat psoriasis, but GI side effects have limited their use.

Dr. Korman has received funding from Centocor, Novartis, and Synta.

The SDEF and this newspaper are wholly owned subsidiaries of Elsevier.

PARIS — To obtain the best cosmetic results, you must intervene early in pediatric dermatologic tumors, Patrick A. Diner, M.D., said at the Fourth International Academy of Cosmetic Dermatology World Congress.

A common misconception is that surgery should be delayed in children because of the potential risks associated with general anesthesia. But research shows that the risk is not relevant after 1 year of age, and that waiting does not guarantee that local anesthesia can be used, especially when a lesion is located on the face, he said.

Dr. Diner recommended early surgical intervention because of the loss of skin elasticity, the potential for a lesion to grow, and the risk of infection, deformity, and loss of function associated with some lesions.

Larger excisions can be performed with better results because younger skin is more elastic and has a significantly thick layer of fat, and there is decreased muscular activity in younger patients, he said.

Early intervention should also be considered to reduce the psychological impact of dermatologic tumors on children, said Dr. Diner, a plastic and reconstructive surgeon with the Armand Trousseau Children's Hospital, University of Paris.

"How can we refuse this early surgery, which can change their quality of life … when later on we will not obtain the same results?" he said.

Waiting to excise dermoid cysts, midline nasal fistulas, and preauricular fistulas can increase the risk of local infection and also lead to a more complex surgery.

In severe cases of preauricular fistula, waiting can put the facial nerve at risk because the resection has to be extended, he said.

Dr. Diner also advocates early surgery with periorbital and orbital hemangiomas because of the risk of amblyopia, astigmatism, and intraorbital infiltration resulting in displacement of the eyeball.

Emergency prophylactic surgery should be considered—despite a normal first ophthalmic examination—with a hemangioma with partial closure of more than one-third of the eye, or with a bulky localized hemangioma.

In his study of 62 patients, average age at surgery was 8 months for orbital hemangiomas. However, he contends that the surgery should happen as soon as possible if there is any risk of visual impairment.

Among 450 patients aged 5 days to 20 years who were treated for calvarial tumors and alopecia at the Armand Trousseau Children's Hospital, 72% were operated on before they were 2 years old, and 15% before they were 3 years old, fellow plastic surgeon Gérald Franchi, M.D., said during the same session at the meeting.

Dr. Franchi said a combination of techniques—such as simple excision, tissue expansion, and skin grafting—is best when dealing with calvarial tumors and alopecia in children. Large skin resection can be performed before the age of 3 months, when skin laxity is greatest. Wound care and skin grafts are the most reasonable approach for aplasia cutis congenita. Simple excision and tissue expansion are suggested for congenital pigmentary nevi, he said, especially if they involve two-thirds of the scalp. The approach doesn't result in growth-related problems later on, although the density of the hair will be affected.

Scalp hemangiomas in children should not be operated on unless ulcerated because of a risk of bleeding, he said.

A large palpebral hemangioma put the development of good vision at risk.

Prophylactic emergency surgery was performed to correct the occlusion. Photos courtesy Dr. Patrick A. Diner

PARIS — To obtain the best cosmetic results, you must intervene early in pediatric dermatologic tumors, Patrick A. Diner, M.D., said at the Fourth International Academy of Cosmetic Dermatology World Congress.

A common misconception is that surgery should be delayed in children because of the potential risks associated with general anesthesia. But research shows that the risk is not relevant after 1 year of age, and that waiting does not guarantee that local anesthesia can be used, especially when a lesion is located on the face, he said.

Dr. Diner recommended early surgical intervention because of the loss of skin elasticity, the potential for a lesion to grow, and the risk of infection, deformity, and loss of function associated with some lesions.

Larger excisions can be performed with better results because younger skin is more elastic and has a significantly thick layer of fat, and there is decreased muscular activity in younger patients, he said.

Early intervention should also be considered to reduce the psychological impact of dermatologic tumors on children, said Dr. Diner, a plastic and reconstructive surgeon with the Armand Trousseau Children's Hospital, University of Paris.

"How can we refuse this early surgery, which can change their quality of life … when later on we will not obtain the same results?" he said.

Waiting to excise dermoid cysts, midline nasal fistulas, and preauricular fistulas can increase the risk of local infection and also lead to a more complex surgery.

In severe cases of preauricular fistula, waiting can put the facial nerve at risk because the resection has to be extended, he said.

Dr. Diner also advocates early surgery with periorbital and orbital hemangiomas because of the risk of amblyopia, astigmatism, and intraorbital infiltration resulting in displacement of the eyeball.

Emergency prophylactic surgery should be considered—despite a normal first ophthalmic examination—with a hemangioma with partial closure of more than one-third of the eye, or with a bulky localized hemangioma.

In his study of 62 patients, average age at surgery was 8 months for orbital hemangiomas. However, he contends that the surgery should happen as soon as possible if there is any risk of visual impairment.

Among 450 patients aged 5 days to 20 years who were treated for calvarial tumors and alopecia at the Armand Trousseau Children's Hospital, 72% were operated on before they were 2 years old, and 15% before they were 3 years old, fellow plastic surgeon Gérald Franchi, M.D., said during the same session at the meeting.

Dr. Franchi said a combination of techniques—such as simple excision, tissue expansion, and skin grafting—is best when dealing with calvarial tumors and alopecia in children. Large skin resection can be performed before the age of 3 months, when skin laxity is greatest. Wound care and skin grafts are the most reasonable approach for aplasia cutis congenita. Simple excision and tissue expansion are suggested for congenital pigmentary nevi, he said, especially if they involve two-thirds of the scalp. The approach doesn't result in growth-related problems later on, although the density of the hair will be affected.

Scalp hemangiomas in children should not be operated on unless ulcerated because of a risk of bleeding, he said.

A large palpebral hemangioma put the development of good vision at risk.

Prophylactic emergency surgery was performed to correct the occlusion. Photos courtesy Dr. Patrick A. Diner

PARIS — To obtain the best cosmetic results, you must intervene early in pediatric dermatologic tumors, Patrick A. Diner, M.D., said at the Fourth International Academy of Cosmetic Dermatology World Congress.

A common misconception is that surgery should be delayed in children because of the potential risks associated with general anesthesia. But research shows that the risk is not relevant after 1 year of age, and that waiting does not guarantee that local anesthesia can be used, especially when a lesion is located on the face, he said.

Dr. Diner recommended early surgical intervention because of the loss of skin elasticity, the potential for a lesion to grow, and the risk of infection, deformity, and loss of function associated with some lesions.

Larger excisions can be performed with better results because younger skin is more elastic and has a significantly thick layer of fat, and there is decreased muscular activity in younger patients, he said.

Early intervention should also be considered to reduce the psychological impact of dermatologic tumors on children, said Dr. Diner, a plastic and reconstructive surgeon with the Armand Trousseau Children's Hospital, University of Paris.

"How can we refuse this early surgery, which can change their quality of life … when later on we will not obtain the same results?" he said.

Waiting to excise dermoid cysts, midline nasal fistulas, and preauricular fistulas can increase the risk of local infection and also lead to a more complex surgery.

In severe cases of preauricular fistula, waiting can put the facial nerve at risk because the resection has to be extended, he said.

Dr. Diner also advocates early surgery with periorbital and orbital hemangiomas because of the risk of amblyopia, astigmatism, and intraorbital infiltration resulting in displacement of the eyeball.

Emergency prophylactic surgery should be considered—despite a normal first ophthalmic examination—with a hemangioma with partial closure of more than one-third of the eye, or with a bulky localized hemangioma.

In his study of 62 patients, average age at surgery was 8 months for orbital hemangiomas. However, he contends that the surgery should happen as soon as possible if there is any risk of visual impairment.

Among 450 patients aged 5 days to 20 years who were treated for calvarial tumors and alopecia at the Armand Trousseau Children's Hospital, 72% were operated on before they were 2 years old, and 15% before they were 3 years old, fellow plastic surgeon Gérald Franchi, M.D., said during the same session at the meeting.

Dr. Franchi said a combination of techniques—such as simple excision, tissue expansion, and skin grafting—is best when dealing with calvarial tumors and alopecia in children. Large skin resection can be performed before the age of 3 months, when skin laxity is greatest. Wound care and skin grafts are the most reasonable approach for aplasia cutis congenita. Simple excision and tissue expansion are suggested for congenital pigmentary nevi, he said, especially if they involve two-thirds of the scalp. The approach doesn't result in growth-related problems later on, although the density of the hair will be affected.

Scalp hemangiomas in children should not be operated on unless ulcerated because of a risk of bleeding, he said.

A large palpebral hemangioma put the development of good vision at risk.

Prophylactic emergency surgery was performed to correct the occlusion. Photos courtesy Dr. Patrick A. Diner

PARIS — The pulsed dye laser can selectively destroy anogenital warts in men without damaging surrounding skin, Ashraf Badawi, M.D., reported at the Fourth International Academy of Cosmetic Dermatology World Congress.

A prospective, observational study found complete clearance of 528 anogenital warts (96%) treated by pulsed dye laser after one to three sessions. Clearance rates with imiquimod and conventional treatments, such as cryosurgery and cautery, range from 32% to 88%, he said.

Pulsed dye lasers have been used at 7.5 J/cm2 to effectively treat perianal warts in children. But this is the first study, to the author's knowledge, to evaluate the role of pulsed dye lasers in the treatment of genital warts in men.

The study also used higher fluences of 9–10 J/cm2 to ensure greater destruction of the vascular component of the lesions, said Dr. Badawi of the National Laser Institute at Cairo (Egypt) University.

Overlapping pulses were used to increase the photothermal effect of the laser radiation, leading to coagulation of the lesions and immediate graying of the warty tissue.

The selective characteristics of the pulsed dye laser allow it to induce less damage to surrounding tissues than other lasers. This leads to less inflammation and pain, he said.

The treatment is performed with topical anesthetic and does not require infiltration anesthesia as used in electrocautery or surgery. It is safe in comparison with the toxic effects of 20% podophyllin antimitotic solution or 0.5% podofilox solution.

The study included 174 men with 550 anogenital warts, uncomplicated by infection, who were referred to the National Laser Institute from January 2000 through December 2004.

Warts were present more often on multiple genital sites in 104 patients (59.78%), and on one genital site in 70 patients (40.22%).

Among those patients, lesions were present on the penis in 39 (22.4%), on the scrotum in 11 (6.32%), on the urethral meatus in 4 (2.29%), and on the perianal area in 16 (9.2%).

The mean duration of the lesions was observed to be 4 months, and the average number of warts was 3.8.

Clearance was determined by independent clinicians, who performed examinations both with and without magnification. Follow-up was a minimum of 4 months and as much as 9 months in some cases.

Patients were treated with up to four pulses from a 585-nm flashlamp-pumped pulsed dye laser (Cynosure Inc., Chelmsford, Mass.), with a 450-μsecond pulse duration, and a spot size of 5–7 mm, depending on the size of the lesion.

Treatment was repeated every 2 weeks, with a maximum of three sessions over a 6-week period.

A total of 528 (96%) warts were completely cleared after one to three sessions. Patients with fewer than three warts and with an area less than 20 mm2 typically cleared after one session.

Three to four overlapping pulses showed better clearance of warts than single or even double pulsing, he said.

Patient age and morphologic type did not affect treatment outcome.

Side effects were infrequent, mostly in the form of mild pain at treatment and transient hypopigmentation after treatment.

Complete resolution and healing in skin without scarring or texture changes were found in most cases.

The recurrence rate at the same site was 5% within 4 months. This compares with a recurrence rate of 8%–22% with conventional treatments, he said.

Pulsed dye lasers could be used to treat anal warts in men and vulval warts in women. But they would not be appropriate for cervical warts, which require a carbon dioxide laser equipped with an appropriate delivery system, Dr. Badawi said.

Dr. Badawi has no financial interest in Cynosure.

PARIS — The pulsed dye laser can selectively destroy anogenital warts in men without damaging surrounding skin, Ashraf Badawi, M.D., reported at the Fourth International Academy of Cosmetic Dermatology World Congress.

A prospective, observational study found complete clearance of 528 anogenital warts (96%) treated by pulsed dye laser after one to three sessions. Clearance rates with imiquimod and conventional treatments, such as cryosurgery and cautery, range from 32% to 88%, he said.

Pulsed dye lasers have been used at 7.5 J/cm2 to effectively treat perianal warts in children. But this is the first study, to the author's knowledge, to evaluate the role of pulsed dye lasers in the treatment of genital warts in men.

The study also used higher fluences of 9–10 J/cm2 to ensure greater destruction of the vascular component of the lesions, said Dr. Badawi of the National Laser Institute at Cairo (Egypt) University.

Overlapping pulses were used to increase the photothermal effect of the laser radiation, leading to coagulation of the lesions and immediate graying of the warty tissue.

The selective characteristics of the pulsed dye laser allow it to induce less damage to surrounding tissues than other lasers. This leads to less inflammation and pain, he said.

The treatment is performed with topical anesthetic and does not require infiltration anesthesia as used in electrocautery or surgery. It is safe in comparison with the toxic effects of 20% podophyllin antimitotic solution or 0.5% podofilox solution.

The study included 174 men with 550 anogenital warts, uncomplicated by infection, who were referred to the National Laser Institute from January 2000 through December 2004.

Warts were present more often on multiple genital sites in 104 patients (59.78%), and on one genital site in 70 patients (40.22%).

Among those patients, lesions were present on the penis in 39 (22.4%), on the scrotum in 11 (6.32%), on the urethral meatus in 4 (2.29%), and on the perianal area in 16 (9.2%).

The mean duration of the lesions was observed to be 4 months, and the average number of warts was 3.8.

Clearance was determined by independent clinicians, who performed examinations both with and without magnification. Follow-up was a minimum of 4 months and as much as 9 months in some cases.

Patients were treated with up to four pulses from a 585-nm flashlamp-pumped pulsed dye laser (Cynosure Inc., Chelmsford, Mass.), with a 450-μsecond pulse duration, and a spot size of 5–7 mm, depending on the size of the lesion.

Treatment was repeated every 2 weeks, with a maximum of three sessions over a 6-week period.

A total of 528 (96%) warts were completely cleared after one to three sessions. Patients with fewer than three warts and with an area less than 20 mm2 typically cleared after one session.

Three to four overlapping pulses showed better clearance of warts than single or even double pulsing, he said.

Patient age and morphologic type did not affect treatment outcome.

Side effects were infrequent, mostly in the form of mild pain at treatment and transient hypopigmentation after treatment.

Complete resolution and healing in skin without scarring or texture changes were found in most cases.

The recurrence rate at the same site was 5% within 4 months. This compares with a recurrence rate of 8%–22% with conventional treatments, he said.

Pulsed dye lasers could be used to treat anal warts in men and vulval warts in women. But they would not be appropriate for cervical warts, which require a carbon dioxide laser equipped with an appropriate delivery system, Dr. Badawi said.

Dr. Badawi has no financial interest in Cynosure.

PARIS — The pulsed dye laser can selectively destroy anogenital warts in men without damaging surrounding skin, Ashraf Badawi, M.D., reported at the Fourth International Academy of Cosmetic Dermatology World Congress.

A prospective, observational study found complete clearance of 528 anogenital warts (96%) treated by pulsed dye laser after one to three sessions. Clearance rates with imiquimod and conventional treatments, such as cryosurgery and cautery, range from 32% to 88%, he said.

Pulsed dye lasers have been used at 7.5 J/cm2 to effectively treat perianal warts in children. But this is the first study, to the author's knowledge, to evaluate the role of pulsed dye lasers in the treatment of genital warts in men.

The study also used higher fluences of 9–10 J/cm2 to ensure greater destruction of the vascular component of the lesions, said Dr. Badawi of the National Laser Institute at Cairo (Egypt) University.

Overlapping pulses were used to increase the photothermal effect of the laser radiation, leading to coagulation of the lesions and immediate graying of the warty tissue.

The selective characteristics of the pulsed dye laser allow it to induce less damage to surrounding tissues than other lasers. This leads to less inflammation and pain, he said.

The treatment is performed with topical anesthetic and does not require infiltration anesthesia as used in electrocautery or surgery. It is safe in comparison with the toxic effects of 20% podophyllin antimitotic solution or 0.5% podofilox solution.

The study included 174 men with 550 anogenital warts, uncomplicated by infection, who were referred to the National Laser Institute from January 2000 through December 2004.

Warts were present more often on multiple genital sites in 104 patients (59.78%), and on one genital site in 70 patients (40.22%).

Among those patients, lesions were present on the penis in 39 (22.4%), on the scrotum in 11 (6.32%), on the urethral meatus in 4 (2.29%), and on the perianal area in 16 (9.2%).

The mean duration of the lesions was observed to be 4 months, and the average number of warts was 3.8.

Clearance was determined by independent clinicians, who performed examinations both with and without magnification. Follow-up was a minimum of 4 months and as much as 9 months in some cases.

Patients were treated with up to four pulses from a 585-nm flashlamp-pumped pulsed dye laser (Cynosure Inc., Chelmsford, Mass.), with a 450-μsecond pulse duration, and a spot size of 5–7 mm, depending on the size of the lesion.

Treatment was repeated every 2 weeks, with a maximum of three sessions over a 6-week period.

A total of 528 (96%) warts were completely cleared after one to three sessions. Patients with fewer than three warts and with an area less than 20 mm2 typically cleared after one session.

Three to four overlapping pulses showed better clearance of warts than single or even double pulsing, he said.

Patient age and morphologic type did not affect treatment outcome.

Side effects were infrequent, mostly in the form of mild pain at treatment and transient hypopigmentation after treatment.

Complete resolution and healing in skin without scarring or texture changes were found in most cases.

The recurrence rate at the same site was 5% within 4 months. This compares with a recurrence rate of 8%–22% with conventional treatments, he said.

Pulsed dye lasers could be used to treat anal warts in men and vulval warts in women. But they would not be appropriate for cervical warts, which require a carbon dioxide laser equipped with an appropriate delivery system, Dr. Badawi said.

Dr. Badawi has no financial interest in Cynosure.

CHICAGO — The combination of methotrexate and alefacept appears to be safe and effective for the treatment of psoriatic arthritis, Mark G. Lebwohl, M.D., said at the 11th International Psoriasis Symposium, sponsored by the Skin Disease Education Foundation.

This is the first study to evaluate alefacept in combination with methotrexate in psoriatic arthritis, which affects about 20%–30% of all psoriasis patients.

Alefacept (Amevive) is approved for psoriasis and demonstrated clinical improvement in an initial pilot in psoriatic arthritis.

In this double-blind study, 185 patients aged 18–70 years with active psoriatic arthritis despite methotrexate treatment for 3 or more months were randomized to 15-mg alefacept once weekly for 12 weeks or placebo. All patients continued on methotrexate at various dosages.

At week 14, 53% of patients in the alefacept group achieved a 50% or greater improvement according to scores on the Psoriasis Area and Severity Index (PASI 50), compared with 17% of the placebo group.

At week 24, 54% of the alefacept/methotrexate-treated patients achieved at least a 20% improvement according to American College of Rheumatology response criteria (ACR 20), compared with 23% of the investigation participants who received methotrexate plus placebo.

Results on both efficacy end points were statistically significant, he said.

The incidence of serious adverse events was 2%, and no serious infections or malignancies were reported in the alefacept-treated group.

Longer-term data for psoriasis shows no increase in malignancies or infections, Dr. Lebwohl noted in an interview. This suggests that the combination of alefacept and methotrexate may be useful in the long-term management of psoriatic arthritis.

In addition to greater efficacy, it's hoped that the combination therapy would allow for reduced methotrexate dosages, he said.

Two other biologic therapies, etanercept and infliximab, have both been used with methotrexate in rheumatoid arthritis, allowing for a reduction in the required dosage of methotrexate.

The rationale for using alefacept is that it selectively reduces memory T-cells, which may play a role in the pathogenesis of psoriatic arthritis, said Dr. Lebwohl, chair of dermatology at Mt. Sinai School of Medicine, New York.

Synovial fluid analyses from psoriatic arthritis patients have shown a reduction in CD4+ and CD8+ cells from baseline following treatment with alefacept. Other T-cell therapies, such as cyclosporine, also have shown some benefit in psoriatic arthritis patients.

Although it's not surprising that therapies targeting T cells might be of benefit in psoriatic arthritis, Dr. Lebwohl noted that a recent efalizumab (Raptiva) trial involving psoriatic arthritis patients did not show similar significant benefits.

Dr. Lebwohl is a consultant, speaker, and investigator for Biogen Inc., which markets alefacept. The SDEF and this newspaper are wholly owned subsidiaries of Elsevier.

CHICAGO — The combination of methotrexate and alefacept appears to be safe and effective for the treatment of psoriatic arthritis, Mark G. Lebwohl, M.D., said at the 11th International Psoriasis Symposium, sponsored by the Skin Disease Education Foundation.

This is the first study to evaluate alefacept in combination with methotrexate in psoriatic arthritis, which affects about 20%–30% of all psoriasis patients.

Alefacept (Amevive) is approved for psoriasis and demonstrated clinical improvement in an initial pilot in psoriatic arthritis.

In this double-blind study, 185 patients aged 18–70 years with active psoriatic arthritis despite methotrexate treatment for 3 or more months were randomized to 15-mg alefacept once weekly for 12 weeks or placebo. All patients continued on methotrexate at various dosages.

At week 14, 53% of patients in the alefacept group achieved a 50% or greater improvement according to scores on the Psoriasis Area and Severity Index (PASI 50), compared with 17% of the placebo group.

At week 24, 54% of the alefacept/methotrexate-treated patients achieved at least a 20% improvement according to American College of Rheumatology response criteria (ACR 20), compared with 23% of the investigation participants who received methotrexate plus placebo.

Results on both efficacy end points were statistically significant, he said.

The incidence of serious adverse events was 2%, and no serious infections or malignancies were reported in the alefacept-treated group.

Longer-term data for psoriasis shows no increase in malignancies or infections, Dr. Lebwohl noted in an interview. This suggests that the combination of alefacept and methotrexate may be useful in the long-term management of psoriatic arthritis.

In addition to greater efficacy, it's hoped that the combination therapy would allow for reduced methotrexate dosages, he said.

Two other biologic therapies, etanercept and infliximab, have both been used with methotrexate in rheumatoid arthritis, allowing for a reduction in the required dosage of methotrexate.

The rationale for using alefacept is that it selectively reduces memory T-cells, which may play a role in the pathogenesis of psoriatic arthritis, said Dr. Lebwohl, chair of dermatology at Mt. Sinai School of Medicine, New York.

Synovial fluid analyses from psoriatic arthritis patients have shown a reduction in CD4+ and CD8+ cells from baseline following treatment with alefacept. Other T-cell therapies, such as cyclosporine, also have shown some benefit in psoriatic arthritis patients.

Although it's not surprising that therapies targeting T cells might be of benefit in psoriatic arthritis, Dr. Lebwohl noted that a recent efalizumab (Raptiva) trial involving psoriatic arthritis patients did not show similar significant benefits.

Dr. Lebwohl is a consultant, speaker, and investigator for Biogen Inc., which markets alefacept. The SDEF and this newspaper are wholly owned subsidiaries of Elsevier.

CHICAGO — The combination of methotrexate and alefacept appears to be safe and effective for the treatment of psoriatic arthritis, Mark G. Lebwohl, M.D., said at the 11th International Psoriasis Symposium, sponsored by the Skin Disease Education Foundation.

This is the first study to evaluate alefacept in combination with methotrexate in psoriatic arthritis, which affects about 20%–30% of all psoriasis patients.

Alefacept (Amevive) is approved for psoriasis and demonstrated clinical improvement in an initial pilot in psoriatic arthritis.

In this double-blind study, 185 patients aged 18–70 years with active psoriatic arthritis despite methotrexate treatment for 3 or more months were randomized to 15-mg alefacept once weekly for 12 weeks or placebo. All patients continued on methotrexate at various dosages.

At week 14, 53% of patients in the alefacept group achieved a 50% or greater improvement according to scores on the Psoriasis Area and Severity Index (PASI 50), compared with 17% of the placebo group.

At week 24, 54% of the alefacept/methotrexate-treated patients achieved at least a 20% improvement according to American College of Rheumatology response criteria (ACR 20), compared with 23% of the investigation participants who received methotrexate plus placebo.

Results on both efficacy end points were statistically significant, he said.

The incidence of serious adverse events was 2%, and no serious infections or malignancies were reported in the alefacept-treated group.

Longer-term data for psoriasis shows no increase in malignancies or infections, Dr. Lebwohl noted in an interview. This suggests that the combination of alefacept and methotrexate may be useful in the long-term management of psoriatic arthritis.

In addition to greater efficacy, it's hoped that the combination therapy would allow for reduced methotrexate dosages, he said.

Two other biologic therapies, etanercept and infliximab, have both been used with methotrexate in rheumatoid arthritis, allowing for a reduction in the required dosage of methotrexate.

The rationale for using alefacept is that it selectively reduces memory T-cells, which may play a role in the pathogenesis of psoriatic arthritis, said Dr. Lebwohl, chair of dermatology at Mt. Sinai School of Medicine, New York.

Synovial fluid analyses from psoriatic arthritis patients have shown a reduction in CD4+ and CD8+ cells from baseline following treatment with alefacept. Other T-cell therapies, such as cyclosporine, also have shown some benefit in psoriatic arthritis patients.

Although it's not surprising that therapies targeting T cells might be of benefit in psoriatic arthritis, Dr. Lebwohl noted that a recent efalizumab (Raptiva) trial involving psoriatic arthritis patients did not show similar significant benefits.

Dr. Lebwohl is a consultant, speaker, and investigator for Biogen Inc., which markets alefacept. The SDEF and this newspaper are wholly owned subsidiaries of Elsevier.

Significantly fewer cases of West Nile virus infection have been reported so far in 2005 compared with this time last year, but federal officials warn the season is still early.

By mid-July, the Centers for Disease Control and Prevention had received reports of 25 cases nationwide, including 1 death in Missouri.

In contrast, by mid July 2004, the CDC had received reports of 108 human cases, including 2 deaths.

There is no way to project where the disease will hit hardest this year, given the limited experience with the virus in the United States or its track record in Europe, Asia, and Africa, said Theresa Smith, M.D., a medical epidemiologist with the CDC division of vector-borne infectious diseases in Fort Collins, Colo.

“It has a seasonal nature, but not a truly cyclical nature,” she said.

Of the 25 cases reported since Jan. 1, 2005, 15 (60%) were reported as West Nile fever, 9 (36%) were reported as West Nile meningitis or encephalitis (neuroinvasive disease), and 1 (4%) had not been clinically defined at press time.

Testing of potential blood donors identified seven people with presumptive West Nile virus infection: Five occurred in Texas and two occurred in Arizona.

The number of overall cases so far is too small to allow comparison of the epidemiology of the virus this year with last year. But acute flaccid paralysis has been recognized more frequently in the last 2 years, Dr. Smith said. None of the cases reported as of press time in 2005 have involved this paralysis syndrome.

One of the first signs of acute flaccid paralysis can be weakness in one limb, but there also may be no symptoms prior to the onset of paralysis.

As with poliomyelitis, numbness is not a feature of acute flaccid paralysis due to West Nile virus, although pain can be present.

Acute flaccid paralysis affects relatively healthy young people, as opposed to West Nile virus encephalitis or meningitis, which tends to affect older people, she said.

The ages of patients infected with West Nile virus to date in 2005 range from 17 to 80 years, and none is believed to be pregnant, CDC spokesperson Christine Pearson said.

The CDC established a voluntary online registry in 2002 to report women who become infected with the virus during pregnancy. The CDC also established a voluntary birth outcome registry.

The action came after a 27-year-old woman infected with the virus delivered a full-term infant with cystic cerebral tissue destruction, severe chorioretinitis, and laboratory evidence of congenitally acquired West Nile virus infection.

There were no confirmed cases of intrauterine transmission in the 79 pregnancies reported to the registry in 2003–2004, Dr. Smith said.

There were three very early cases of postnatal West Nile virus infections that may have involved transplacental infection or virus transmission during delivery.

There have been nine major birth defects (12%) among the 79 pregnancies. But the birth defects were felt to be “chance occurrences” based on the phenotypic inconsistencies observed, she said.

There was some evidence of a possible pattern of microcephaly, but the numbers were too small to be conclusive.

“The registry is helping us understand what risks are present, and whether pregnancy with West Nile virus has definable, discernible outcomes,” Dr. Smith said.

In February 2004, the CDC issued interim guidelines for evaluating infants born to mothers who acquire infection during pregnancy, but the agency did not advocate screening of asymptomatic pregnant women.

Screening, even in highly endemic areas, is not recommended given the lack of specific treatment for West Nile virus infection, Dr. Smith said, adding that the final infant evaluation guidelines are not expected for some time.

As of mid-July, Colorado had the highest number of cases with seven, followed by South Dakota (five), Arizona (three) and two cases each in California and New Mexico.

In 2004, 2,535 total human cases and 98 deaths were reported to the CDC, with the largest number of cases in Western states.

The highest number of reported cases was in 2003, with 9,862 cases of human illness and 264 deaths.

Significantly fewer cases of West Nile virus infection have been reported so far in 2005 compared with this time last year, but federal officials warn the season is still early.

By mid-July, the Centers for Disease Control and Prevention had received reports of 25 cases nationwide, including 1 death in Missouri.

In contrast, by mid July 2004, the CDC had received reports of 108 human cases, including 2 deaths.

There is no way to project where the disease will hit hardest this year, given the limited experience with the virus in the United States or its track record in Europe, Asia, and Africa, said Theresa Smith, M.D., a medical epidemiologist with the CDC division of vector-borne infectious diseases in Fort Collins, Colo.

“It has a seasonal nature, but not a truly cyclical nature,” she said.

Of the 25 cases reported since Jan. 1, 2005, 15 (60%) were reported as West Nile fever, 9 (36%) were reported as West Nile meningitis or encephalitis (neuroinvasive disease), and 1 (4%) had not been clinically defined at press time.

Testing of potential blood donors identified seven people with presumptive West Nile virus infection: Five occurred in Texas and two occurred in Arizona.

The number of overall cases so far is too small to allow comparison of the epidemiology of the virus this year with last year. But acute flaccid paralysis has been recognized more frequently in the last 2 years, Dr. Smith said. None of the cases reported as of press time in 2005 have involved this paralysis syndrome.

One of the first signs of acute flaccid paralysis can be weakness in one limb, but there also may be no symptoms prior to the onset of paralysis.

As with poliomyelitis, numbness is not a feature of acute flaccid paralysis due to West Nile virus, although pain can be present.

Acute flaccid paralysis affects relatively healthy young people, as opposed to West Nile virus encephalitis or meningitis, which tends to affect older people, she said.

The ages of patients infected with West Nile virus to date in 2005 range from 17 to 80 years, and none is believed to be pregnant, CDC spokesperson Christine Pearson said.

The CDC established a voluntary online registry in 2002 to report women who become infected with the virus during pregnancy. The CDC also established a voluntary birth outcome registry.

The action came after a 27-year-old woman infected with the virus delivered a full-term infant with cystic cerebral tissue destruction, severe chorioretinitis, and laboratory evidence of congenitally acquired West Nile virus infection.

There were no confirmed cases of intrauterine transmission in the 79 pregnancies reported to the registry in 2003–2004, Dr. Smith said.

There were three very early cases of postnatal West Nile virus infections that may have involved transplacental infection or virus transmission during delivery.

There have been nine major birth defects (12%) among the 79 pregnancies. But the birth defects were felt to be “chance occurrences” based on the phenotypic inconsistencies observed, she said.

There was some evidence of a possible pattern of microcephaly, but the numbers were too small to be conclusive.

“The registry is helping us understand what risks are present, and whether pregnancy with West Nile virus has definable, discernible outcomes,” Dr. Smith said.

In February 2004, the CDC issued interim guidelines for evaluating infants born to mothers who acquire infection during pregnancy, but the agency did not advocate screening of asymptomatic pregnant women.

Screening, even in highly endemic areas, is not recommended given the lack of specific treatment for West Nile virus infection, Dr. Smith said, adding that the final infant evaluation guidelines are not expected for some time.

As of mid-July, Colorado had the highest number of cases with seven, followed by South Dakota (five), Arizona (three) and two cases each in California and New Mexico.

In 2004, 2,535 total human cases and 98 deaths were reported to the CDC, with the largest number of cases in Western states.

The highest number of reported cases was in 2003, with 9,862 cases of human illness and 264 deaths.

Significantly fewer cases of West Nile virus infection have been reported so far in 2005 compared with this time last year, but federal officials warn the season is still early.

By mid-July, the Centers for Disease Control and Prevention had received reports of 25 cases nationwide, including 1 death in Missouri.

In contrast, by mid July 2004, the CDC had received reports of 108 human cases, including 2 deaths.

There is no way to project where the disease will hit hardest this year, given the limited experience with the virus in the United States or its track record in Europe, Asia, and Africa, said Theresa Smith, M.D., a medical epidemiologist with the CDC division of vector-borne infectious diseases in Fort Collins, Colo.

“It has a seasonal nature, but not a truly cyclical nature,” she said.

Of the 25 cases reported since Jan. 1, 2005, 15 (60%) were reported as West Nile fever, 9 (36%) were reported as West Nile meningitis or encephalitis (neuroinvasive disease), and 1 (4%) had not been clinically defined at press time.

Testing of potential blood donors identified seven people with presumptive West Nile virus infection: Five occurred in Texas and two occurred in Arizona.

The number of overall cases so far is too small to allow comparison of the epidemiology of the virus this year with last year. But acute flaccid paralysis has been recognized more frequently in the last 2 years, Dr. Smith said. None of the cases reported as of press time in 2005 have involved this paralysis syndrome.

One of the first signs of acute flaccid paralysis can be weakness in one limb, but there also may be no symptoms prior to the onset of paralysis.

As with poliomyelitis, numbness is not a feature of acute flaccid paralysis due to West Nile virus, although pain can be present.

Acute flaccid paralysis affects relatively healthy young people, as opposed to West Nile virus encephalitis or meningitis, which tends to affect older people, she said.

The ages of patients infected with West Nile virus to date in 2005 range from 17 to 80 years, and none is believed to be pregnant, CDC spokesperson Christine Pearson said.

The CDC established a voluntary online registry in 2002 to report women who become infected with the virus during pregnancy. The CDC also established a voluntary birth outcome registry.

The action came after a 27-year-old woman infected with the virus delivered a full-term infant with cystic cerebral tissue destruction, severe chorioretinitis, and laboratory evidence of congenitally acquired West Nile virus infection.

There were no confirmed cases of intrauterine transmission in the 79 pregnancies reported to the registry in 2003–2004, Dr. Smith said.

There were three very early cases of postnatal West Nile virus infections that may have involved transplacental infection or virus transmission during delivery.

There have been nine major birth defects (12%) among the 79 pregnancies. But the birth defects were felt to be “chance occurrences” based on the phenotypic inconsistencies observed, she said.

There was some evidence of a possible pattern of microcephaly, but the numbers were too small to be conclusive.

“The registry is helping us understand what risks are present, and whether pregnancy with West Nile virus has definable, discernible outcomes,” Dr. Smith said.

In February 2004, the CDC issued interim guidelines for evaluating infants born to mothers who acquire infection during pregnancy, but the agency did not advocate screening of asymptomatic pregnant women.

Screening, even in highly endemic areas, is not recommended given the lack of specific treatment for West Nile virus infection, Dr. Smith said, adding that the final infant evaluation guidelines are not expected for some time.

As of mid-July, Colorado had the highest number of cases with seven, followed by South Dakota (five), Arizona (three) and two cases each in California and New Mexico.

In 2004, 2,535 total human cases and 98 deaths were reported to the CDC, with the largest number of cases in Western states.

The highest number of reported cases was in 2003, with 9,862 cases of human illness and 264 deaths.

NEW ORLEANS — A combined formulation of clindamycin (1%) and tretinoin (0.025%) in an aqueous hydrogel improved acne vulgaris significantly faster than did either drug alone or vehicle, James Leyden, M.D., reported in a poster presentation at the annual meeting of the American Academy of Dermatology.

The combination gel targets three factors in acne pathogenesis, according to Dr. Leyden, a consultant for Connetics Corp., which developed Velac gel and sponsored the studies.

Clindamycin targets Propionibacterium acnes and decreases inflammation, while topical tretinoin normalizes follicular keratinization.

Data were pooled from two phase III, randomized, double-blind, multicenter trials that evaluated 2,219 patients with acne vulgaris at 37 U.S. sites.

Patients were randomized to one of four treatment groups: combination gel, clindamycin, tretinoin, or vehicle. Treatments were applied once daily in the evening for 12 weeks.

Of the 2,219 patients enrolled (combination 634, clindamycin 635, tretinoin 635, and vehicle 315), 1,902 (85.7%) patients completed the two trials.

From baseline to week 12, the percentage reduction in total lesions was significantly greater with the combination gel (48.7%) than with either clindamycin (38.3%) or tretinoin (40.3%) alone, or the vehicle (23.3%).

The median time to a 50% reduction in total lesion counts was 8 weeks with the combination gel, which was significantly faster than with clindamycin (12 weeks), tretinoin (12 weeks), or vehicle.

The reduction in inflammatory and noninflammatory lesion counts also was significantly greater with the combination gel than with each agent alone.

At week 12, the number of patients who were “clear” or “almost clear” on the investigator's static global assessment was significantly higher in the combination group than in each of the other three treatment groups.

The combination of clindamycin and tretinoin was well tolerated, with a similar incidence of site reactions as tretinoin monotherapy, reported Dr. Leyden, of the University of Pennsylvania, Philadelphia.

In the combination group, 119 patients (19%) reported 207 incidences of application site reactions including dryness, desquamation, burning, erythema, and pruritus.

In the tretinoin group, 107 (17%) reported 190 incidences of application site reactions.

Velac gel is under review by the Food and Drug Administration and is expected to be available in the third quarter of 2005, according to a company spokesperson.

NEW ORLEANS — A combined formulation of clindamycin (1%) and tretinoin (0.025%) in an aqueous hydrogel improved acne vulgaris significantly faster than did either drug alone or vehicle, James Leyden, M.D., reported in a poster presentation at the annual meeting of the American Academy of Dermatology.

The combination gel targets three factors in acne pathogenesis, according to Dr. Leyden, a consultant for Connetics Corp., which developed Velac gel and sponsored the studies.

Clindamycin targets Propionibacterium acnes and decreases inflammation, while topical tretinoin normalizes follicular keratinization.

Data were pooled from two phase III, randomized, double-blind, multicenter trials that evaluated 2,219 patients with acne vulgaris at 37 U.S. sites.

Patients were randomized to one of four treatment groups: combination gel, clindamycin, tretinoin, or vehicle. Treatments were applied once daily in the evening for 12 weeks.

Of the 2,219 patients enrolled (combination 634, clindamycin 635, tretinoin 635, and vehicle 315), 1,902 (85.7%) patients completed the two trials.

From baseline to week 12, the percentage reduction in total lesions was significantly greater with the combination gel (48.7%) than with either clindamycin (38.3%) or tretinoin (40.3%) alone, or the vehicle (23.3%).

The median time to a 50% reduction in total lesion counts was 8 weeks with the combination gel, which was significantly faster than with clindamycin (12 weeks), tretinoin (12 weeks), or vehicle.

The reduction in inflammatory and noninflammatory lesion counts also was significantly greater with the combination gel than with each agent alone.

At week 12, the number of patients who were “clear” or “almost clear” on the investigator's static global assessment was significantly higher in the combination group than in each of the other three treatment groups.

The combination of clindamycin and tretinoin was well tolerated, with a similar incidence of site reactions as tretinoin monotherapy, reported Dr. Leyden, of the University of Pennsylvania, Philadelphia.

In the combination group, 119 patients (19%) reported 207 incidences of application site reactions including dryness, desquamation, burning, erythema, and pruritus.

In the tretinoin group, 107 (17%) reported 190 incidences of application site reactions.

Velac gel is under review by the Food and Drug Administration and is expected to be available in the third quarter of 2005, according to a company spokesperson.

NEW ORLEANS — A combined formulation of clindamycin (1%) and tretinoin (0.025%) in an aqueous hydrogel improved acne vulgaris significantly faster than did either drug alone or vehicle, James Leyden, M.D., reported in a poster presentation at the annual meeting of the American Academy of Dermatology.

The combination gel targets three factors in acne pathogenesis, according to Dr. Leyden, a consultant for Connetics Corp., which developed Velac gel and sponsored the studies.

Clindamycin targets Propionibacterium acnes and decreases inflammation, while topical tretinoin normalizes follicular keratinization.

Data were pooled from two phase III, randomized, double-blind, multicenter trials that evaluated 2,219 patients with acne vulgaris at 37 U.S. sites.

Patients were randomized to one of four treatment groups: combination gel, clindamycin, tretinoin, or vehicle. Treatments were applied once daily in the evening for 12 weeks.

Of the 2,219 patients enrolled (combination 634, clindamycin 635, tretinoin 635, and vehicle 315), 1,902 (85.7%) patients completed the two trials.

From baseline to week 12, the percentage reduction in total lesions was significantly greater with the combination gel (48.7%) than with either clindamycin (38.3%) or tretinoin (40.3%) alone, or the vehicle (23.3%).

The median time to a 50% reduction in total lesion counts was 8 weeks with the combination gel, which was significantly faster than with clindamycin (12 weeks), tretinoin (12 weeks), or vehicle.

The reduction in inflammatory and noninflammatory lesion counts also was significantly greater with the combination gel than with each agent alone.

At week 12, the number of patients who were “clear” or “almost clear” on the investigator's static global assessment was significantly higher in the combination group than in each of the other three treatment groups.

The combination of clindamycin and tretinoin was well tolerated, with a similar incidence of site reactions as tretinoin monotherapy, reported Dr. Leyden, of the University of Pennsylvania, Philadelphia.

In the combination group, 119 patients (19%) reported 207 incidences of application site reactions including dryness, desquamation, burning, erythema, and pruritus.

In the tretinoin group, 107 (17%) reported 190 incidences of application site reactions.

Velac gel is under review by the Food and Drug Administration and is expected to be available in the third quarter of 2005, according to a company spokesperson.

ATLANTA — Concurrent full-dose preoperative gemcitabine and radiation result in significant tumor response and acceptable toxicity in patients with resectable pancreatic cancer, according to data from a phase II multicenter trial.

In previous trials, investigators backed off from giving full-dose gemcitabine (Gemzar) with conventional whole-dose radiation because of high toxicity levels. This protocol, whose results are encouraging, was designed instead to deliver high levels of systemic chemotherapy with lower-dose radiation, Mark S. Talamonti, M.D., said at a symposium sponsored by the Society of Surgical Oncology.

The trial accrued 41 pancreatic cancer patients from five institutions. Twenty of the patients had resectable disease, while the rest showed no evidence of metastatic cancer but had unresectable disease.

Patients were treated preoperatively with three cycles of gemcitabine, and radiation was given during the second cycle. Cycles 1 and 3 consisted of 1,000 mg/m

Of the 20 patients taken to surgery, 17 (85%) underwent resections, including 16 pancreaticoduodenectomies and 1 distal pancreatectomy. Biopsy of metastases was performed only on the three patients who could not undergo resection. The complication rate was 24%, and there were no operative deaths. About one in four patients needed a vascular resection. This wasn't due to tumor adherence or invasion of the veins, but rather, was related to an “incredible fibrotic reaction” seen in the resected specimens, possibly as an effect of treatment, said Dr. Talamonti of Northwestern University, Chicago.

At 12 months' follow-up, 10 (59%) of the 17 patients who underwent resection were alive with no recurrence, 4 (24%) had distant metastases, and 3 (18%) had died.

Pathology revealed clear margins in 16 (94%) of the 17 patients who underwent surgery, and unresolved lymph nodes in 11 (65%) of the 17. One specimen contained no residual tumor, and three specimens revealed only microscopic foci of residual disease.

What some of the other trials underestimated is the capability of gemcitabine to serve as a radiation sensitizer, Dr. Talamonti noted. “What we tried to do is decrease the amount of radiation, assuming that gemcitabine was not only acting systemically but that it was also a potent radiation sensitizer,” he said.

Another advantage of the protocol is that there was no delay in surgery because it was well tolerated and caused no severe debilitation. All 20 patients underwent surgery within 6 weeks after their last gemcitabine infusion, which is comparable with other neoadjuvant trials, he said.

“I think that's a big advantage of this in addition to the response rates,” Dr. Talamonti said. He did not present data on the 21 patients with unresectable disease but said they exhibited higher levels of toxicity than patients with resectable disease because they started with a higher tumor load and had a generally lower performance status.

In general, these patients did show significant treatment responses, and some went on to exploratory surgery.

However, at this point it would be an overstatement to say that the protocol is something that can be used to downstage unresectable into resectable disease, Dr. Talamonti said.

ATLANTA — Concurrent full-dose preoperative gemcitabine and radiation result in significant tumor response and acceptable toxicity in patients with resectable pancreatic cancer, according to data from a phase II multicenter trial.

In previous trials, investigators backed off from giving full-dose gemcitabine (Gemzar) with conventional whole-dose radiation because of high toxicity levels. This protocol, whose results are encouraging, was designed instead to deliver high levels of systemic chemotherapy with lower-dose radiation, Mark S. Talamonti, M.D., said at a symposium sponsored by the Society of Surgical Oncology.

The trial accrued 41 pancreatic cancer patients from five institutions. Twenty of the patients had resectable disease, while the rest showed no evidence of metastatic cancer but had unresectable disease.

Patients were treated preoperatively with three cycles of gemcitabine, and radiation was given during the second cycle. Cycles 1 and 3 consisted of 1,000 mg/m

Of the 20 patients taken to surgery, 17 (85%) underwent resections, including 16 pancreaticoduodenectomies and 1 distal pancreatectomy. Biopsy of metastases was performed only on the three patients who could not undergo resection. The complication rate was 24%, and there were no operative deaths. About one in four patients needed a vascular resection. This wasn't due to tumor adherence or invasion of the veins, but rather, was related to an “incredible fibrotic reaction” seen in the resected specimens, possibly as an effect of treatment, said Dr. Talamonti of Northwestern University, Chicago.

At 12 months' follow-up, 10 (59%) of the 17 patients who underwent resection were alive with no recurrence, 4 (24%) had distant metastases, and 3 (18%) had died.

Pathology revealed clear margins in 16 (94%) of the 17 patients who underwent surgery, and unresolved lymph nodes in 11 (65%) of the 17. One specimen contained no residual tumor, and three specimens revealed only microscopic foci of residual disease.

What some of the other trials underestimated is the capability of gemcitabine to serve as a radiation sensitizer, Dr. Talamonti noted. “What we tried to do is decrease the amount of radiation, assuming that gemcitabine was not only acting systemically but that it was also a potent radiation sensitizer,” he said.

Another advantage of the protocol is that there was no delay in surgery because it was well tolerated and caused no severe debilitation. All 20 patients underwent surgery within 6 weeks after their last gemcitabine infusion, which is comparable with other neoadjuvant trials, he said.

“I think that's a big advantage of this in addition to the response rates,” Dr. Talamonti said. He did not present data on the 21 patients with unresectable disease but said they exhibited higher levels of toxicity than patients with resectable disease because they started with a higher tumor load and had a generally lower performance status.

In general, these patients did show significant treatment responses, and some went on to exploratory surgery.

However, at this point it would be an overstatement to say that the protocol is something that can be used to downstage unresectable into resectable disease, Dr. Talamonti said.

ATLANTA — Concurrent full-dose preoperative gemcitabine and radiation result in significant tumor response and acceptable toxicity in patients with resectable pancreatic cancer, according to data from a phase II multicenter trial.

In previous trials, investigators backed off from giving full-dose gemcitabine (Gemzar) with conventional whole-dose radiation because of high toxicity levels. This protocol, whose results are encouraging, was designed instead to deliver high levels of systemic chemotherapy with lower-dose radiation, Mark S. Talamonti, M.D., said at a symposium sponsored by the Society of Surgical Oncology.

The trial accrued 41 pancreatic cancer patients from five institutions. Twenty of the patients had resectable disease, while the rest showed no evidence of metastatic cancer but had unresectable disease.

Patients were treated preoperatively with three cycles of gemcitabine, and radiation was given during the second cycle. Cycles 1 and 3 consisted of 1,000 mg/m

Of the 20 patients taken to surgery, 17 (85%) underwent resections, including 16 pancreaticoduodenectomies and 1 distal pancreatectomy. Biopsy of metastases was performed only on the three patients who could not undergo resection. The complication rate was 24%, and there were no operative deaths. About one in four patients needed a vascular resection. This wasn't due to tumor adherence or invasion of the veins, but rather, was related to an “incredible fibrotic reaction” seen in the resected specimens, possibly as an effect of treatment, said Dr. Talamonti of Northwestern University, Chicago.

At 12 months' follow-up, 10 (59%) of the 17 patients who underwent resection were alive with no recurrence, 4 (24%) had distant metastases, and 3 (18%) had died.

Pathology revealed clear margins in 16 (94%) of the 17 patients who underwent surgery, and unresolved lymph nodes in 11 (65%) of the 17. One specimen contained no residual tumor, and three specimens revealed only microscopic foci of residual disease.

What some of the other trials underestimated is the capability of gemcitabine to serve as a radiation sensitizer, Dr. Talamonti noted. “What we tried to do is decrease the amount of radiation, assuming that gemcitabine was not only acting systemically but that it was also a potent radiation sensitizer,” he said.

Another advantage of the protocol is that there was no delay in surgery because it was well tolerated and caused no severe debilitation. All 20 patients underwent surgery within 6 weeks after their last gemcitabine infusion, which is comparable with other neoadjuvant trials, he said.

“I think that's a big advantage of this in addition to the response rates,” Dr. Talamonti said. He did not present data on the 21 patients with unresectable disease but said they exhibited higher levels of toxicity than patients with resectable disease because they started with a higher tumor load and had a generally lower performance status.

In general, these patients did show significant treatment responses, and some went on to exploratory surgery.

However, at this point it would be an overstatement to say that the protocol is something that can be used to downstage unresectable into resectable disease, Dr. Talamonti said.

Calcium and vitamin D supplements do not appear to reduce the risk of fractures among older, community-dwelling women, according to David J. Torgerson, Ph.D., of the University of York (England), and his colleagues.

Although supplementation with calcium and vitamin D are routinely recommended for fracture prevention in the elderly, this is the second study to recently call this practice into question.

Results from a secondary prevention trial, also in the United Kingdom, failed to show any benefit of calcium or vitamin D, either alone or in combination, in preventing fractures (Lancet 2005;365:1621–8).

Dr. Torgerson's study randomly assigned 1,321 women to receive 1,000 mg calcium plus 800 IU cholecalciferol (vitamin D3) daily and a leaflet on calcium intake and prevention of falls, and 1,993 women were given the leaflet only.

The women were aged 70 years or older, and had one or more risk factors for hip fracture (BMJ 2005;330:1003).

Over an average follow-up of 25 months, there were 149 clinical fractures, which was lower than expected. But the difference in fracture rates between the supplemented group and the control group was not significant (58 vs. 91). In the supplemented group, the odds ratio was 1.01 for all fractures and 0.75 for hip fractures.

There was no evidence that vitamin D supplementation reduced the incidence of falls, as previously hypothesized. A recent metaanalysis found a 22% reduction in falls in the elderly with vitamin D supplementation (JAMA 2004;291:1999–2006).

Calcium and vitamin D supplements have been shown to reduce hip fractures among women living in nursing homes. “People living in sheltered accommodation or nursing homes may be at more risk of a low calcium and vitamin D intake and at higher risk of fracture,” the authors suggest. Limitations of the study were that it lacked a placebo preparation, was underpowered, and had relatively wide confidence intervals, the authors noted.

Calcium and vitamin D supplements do not appear to reduce the risk of fractures among older, community-dwelling women, according to David J. Torgerson, Ph.D., of the University of York (England), and his colleagues.

Although supplementation with calcium and vitamin D are routinely recommended for fracture prevention in the elderly, this is the second study to recently call this practice into question.

Results from a secondary prevention trial, also in the United Kingdom, failed to show any benefit of calcium or vitamin D, either alone or in combination, in preventing fractures (Lancet 2005;365:1621–8).

Dr. Torgerson's study randomly assigned 1,321 women to receive 1,000 mg calcium plus 800 IU cholecalciferol (vitamin D3) daily and a leaflet on calcium intake and prevention of falls, and 1,993 women were given the leaflet only.

The women were aged 70 years or older, and had one or more risk factors for hip fracture (BMJ 2005;330:1003).

Over an average follow-up of 25 months, there were 149 clinical fractures, which was lower than expected. But the difference in fracture rates between the supplemented group and the control group was not significant (58 vs. 91). In the supplemented group, the odds ratio was 1.01 for all fractures and 0.75 for hip fractures.

There was no evidence that vitamin D supplementation reduced the incidence of falls, as previously hypothesized. A recent metaanalysis found a 22% reduction in falls in the elderly with vitamin D supplementation (JAMA 2004;291:1999–2006).

Calcium and vitamin D supplements have been shown to reduce hip fractures among women living in nursing homes. “People living in sheltered accommodation or nursing homes may be at more risk of a low calcium and vitamin D intake and at higher risk of fracture,” the authors suggest. Limitations of the study were that it lacked a placebo preparation, was underpowered, and had relatively wide confidence intervals, the authors noted.

Calcium and vitamin D supplements do not appear to reduce the risk of fractures among older, community-dwelling women, according to David J. Torgerson, Ph.D., of the University of York (England), and his colleagues.

Although supplementation with calcium and vitamin D are routinely recommended for fracture prevention in the elderly, this is the second study to recently call this practice into question.

Results from a secondary prevention trial, also in the United Kingdom, failed to show any benefit of calcium or vitamin D, either alone or in combination, in preventing fractures (Lancet 2005;365:1621–8).

Dr. Torgerson's study randomly assigned 1,321 women to receive 1,000 mg calcium plus 800 IU cholecalciferol (vitamin D3) daily and a leaflet on calcium intake and prevention of falls, and 1,993 women were given the leaflet only.

The women were aged 70 years or older, and had one or more risk factors for hip fracture (BMJ 2005;330:1003).

Over an average follow-up of 25 months, there were 149 clinical fractures, which was lower than expected. But the difference in fracture rates between the supplemented group and the control group was not significant (58 vs. 91). In the supplemented group, the odds ratio was 1.01 for all fractures and 0.75 for hip fractures.

There was no evidence that vitamin D supplementation reduced the incidence of falls, as previously hypothesized. A recent metaanalysis found a 22% reduction in falls in the elderly with vitamin D supplementation (JAMA 2004;291:1999–2006).

Calcium and vitamin D supplements have been shown to reduce hip fractures among women living in nursing homes. “People living in sheltered accommodation or nursing homes may be at more risk of a low calcium and vitamin D intake and at higher risk of fracture,” the authors suggest. Limitations of the study were that it lacked a placebo preparation, was underpowered, and had relatively wide confidence intervals, the authors noted.

Calcium and vitamin D supplements do not appear to reduce the risk of fractures among older, community-dwelling women, according to David J. Torgerson, Ph.D., of the University of York (England), and his colleagues.

Although supplementation with calcium and vitamin D are routinely recommended for fracture prevention in the elderly, this is the second study in recent weeks to call this practice into question.

A secondary prevention trial, also in the United Kingdom, failed to show any benefit of calcium or vitamin D, either alone or in combination, in preventing fractures (Lancet 2005;365:1621–8).

Dr. Torgerson's study randomly assigned 1,321 women to receive 1,000 mg calcium plus 800 IU cholecalciferol (vitamin D₃) daily and a leaflet on calcium intake and prevention of falls, and 1,993 women were given the leaflet only.

The women were aged 70 years or older, and had one or more risk factors for hip fracture (BMJ 2005;330:1003).

Over an average follow-up of 25 months, there were 149 clinical fractures, which was lower than expected. But the difference in fracture rates between the supplemented and control groups was not significant (58 vs. 91).

In the supplemented group, the odds ratio was 1.01 for all fractures and 0.75 for hip fractures.

There was no evidence that vitamin D supplementation reduced the incidence of falls, as previously hypothesized.

A recent metaanalysis found a 22% reduction in falls with vitamin D supplementation (JAMA 2004;291:1999–2006).

Calcium and vitamin D supplements have been shown to reduce hip fractures among older women in French nursing homes.

“People living in sheltered accommodation or nursing homes may be at more risk of a low calcium and vitamin D intake and at higher risk of fracture,” the authors suggest.

Limitations of the study were that it lacked a placebo preparation, was underpowered, and had relatively wide confidence intervals, the authors noted.

Calcium and vitamin D supplements do not appear to reduce the risk of fractures among older, community-dwelling women, according to David J. Torgerson, Ph.D., of the University of York (England), and his colleagues.

Although supplementation with calcium and vitamin D are routinely recommended for fracture prevention in the elderly, this is the second study in recent weeks to call this practice into question.

A secondary prevention trial, also in the United Kingdom, failed to show any benefit of calcium or vitamin D, either alone or in combination, in preventing fractures (Lancet 2005;365:1621–8).

Dr. Torgerson's study randomly assigned 1,321 women to receive 1,000 mg calcium plus 800 IU cholecalciferol (vitamin D₃) daily and a leaflet on calcium intake and prevention of falls, and 1,993 women were given the leaflet only.

The women were aged 70 years or older, and had one or more risk factors for hip fracture (BMJ 2005;330:1003).

Over an average follow-up of 25 months, there were 149 clinical fractures, which was lower than expected. But the difference in fracture rates between the supplemented and control groups was not significant (58 vs. 91).

In the supplemented group, the odds ratio was 1.01 for all fractures and 0.75 for hip fractures.

There was no evidence that vitamin D supplementation reduced the incidence of falls, as previously hypothesized.

A recent metaanalysis found a 22% reduction in falls with vitamin D supplementation (JAMA 2004;291:1999–2006).

Calcium and vitamin D supplements have been shown to reduce hip fractures among older women in French nursing homes.

“People living in sheltered accommodation or nursing homes may be at more risk of a low calcium and vitamin D intake and at higher risk of fracture,” the authors suggest.

Limitations of the study were that it lacked a placebo preparation, was underpowered, and had relatively wide confidence intervals, the authors noted.

Calcium and vitamin D supplements do not appear to reduce the risk of fractures among older, community-dwelling women, according to David J. Torgerson, Ph.D., of the University of York (England), and his colleagues.

Although supplementation with calcium and vitamin D are routinely recommended for fracture prevention in the elderly, this is the second study in recent weeks to call this practice into question.

A secondary prevention trial, also in the United Kingdom, failed to show any benefit of calcium or vitamin D, either alone or in combination, in preventing fractures (Lancet 2005;365:1621–8).

Dr. Torgerson's study randomly assigned 1,321 women to receive 1,000 mg calcium plus 800 IU cholecalciferol (vitamin D₃) daily and a leaflet on calcium intake and prevention of falls, and 1,993 women were given the leaflet only.

The women were aged 70 years or older, and had one or more risk factors for hip fracture (BMJ 2005;330:1003).

Over an average follow-up of 25 months, there were 149 clinical fractures, which was lower than expected. But the difference in fracture rates between the supplemented and control groups was not significant (58 vs. 91).

In the supplemented group, the odds ratio was 1.01 for all fractures and 0.75 for hip fractures.

There was no evidence that vitamin D supplementation reduced the incidence of falls, as previously hypothesized.

A recent metaanalysis found a 22% reduction in falls with vitamin D supplementation (JAMA 2004;291:1999–2006).

Calcium and vitamin D supplements have been shown to reduce hip fractures among older women in French nursing homes.

“People living in sheltered accommodation or nursing homes may be at more risk of a low calcium and vitamin D intake and at higher risk of fracture,” the authors suggest.

Limitations of the study were that it lacked a placebo preparation, was underpowered, and had relatively wide confidence intervals, the authors noted.

NEW ORLEANS — Treatment with once-daily, high-dose valacyclovir significantly decreases the duration and quantity of oral herpes simplex virus-1 shedding associated with recurrent herpes labialis, according to data from a randomized study.

Oral shedding, either associated with known outbreaks of herpes labialis or, perhaps more importantly, during asymptomatic periods, is the presumed mode of transmission of herpes simplex virus-1 (HSV-1), Stan C. Gilbert, M.D., said in a poster presentation at the annual meeting of the American Academy of Dermatology.

HSV-1 causes gingivostomatitis in infants and children and recurrent cold sores in most people. It also has become the primary cause of genital herpes in the majority of cases among young adults. Recurrent herpes labialis (RHL) affects up to 40% of HSV-1-seropositive adults.

Research has shown oral shedding associated with episodes of RHL lasting from 1 to 8 days. But the studies are rare and have relied mostly on viral cultures, according to Dr. Gilbert, of the University of Washington, Seattle.

His study randomized 64 adults with a history of three or more RHL episodes a year to four 500-mg valacyclovir (Valtrex) caplets taken at the first sign of an outbreak or placebo. The dosing was repeated 12 hours later. Polymerase chain reaction (PCR) swabs were collected every 12 hours starting at the first sign of outbreak and continuing for 10 days. Both groups had a history of cold sores for an average of 28 years and an average of four cold sores in the previous 12 months.

Patients receiving valacyclovir experienced fewer days of shedding than did the placebo group (1.8 vs. 4 days). A comparison of the log HSV-1 DNA copies detected by PCR over time, using the average area under the curve (AUC), showed significantly less shedding from the valacyclovir-treated patients than from the placebo-treated patients (average AUC 1.1 vs. 2.2).

The study's findings are important because information about the natural history of oral HSV-1 shedding and the impact of antivirals may help to reduce transmission rates, Dr. Gilbert said. Dr. Gilbert is a member of the speakers' bureau for GlaxoSmithKline Inc., which manufactures Valtrex and provided 50% of the funding for the study.

NEW ORLEANS — Treatment with once-daily, high-dose valacyclovir significantly decreases the duration and quantity of oral herpes simplex virus-1 shedding associated with recurrent herpes labialis, according to data from a randomized study.

Oral shedding, either associated with known outbreaks of herpes labialis or, perhaps more importantly, during asymptomatic periods, is the presumed mode of transmission of herpes simplex virus-1 (HSV-1), Stan C. Gilbert, M.D., said in a poster presentation at the annual meeting of the American Academy of Dermatology.

HSV-1 causes gingivostomatitis in infants and children and recurrent cold sores in most people. It also has become the primary cause of genital herpes in the majority of cases among young adults. Recurrent herpes labialis (RHL) affects up to 40% of HSV-1-seropositive adults.

Research has shown oral shedding associated with episodes of RHL lasting from 1 to 8 days. But the studies are rare and have relied mostly on viral cultures, according to Dr. Gilbert, of the University of Washington, Seattle.

His study randomized 64 adults with a history of three or more RHL episodes a year to four 500-mg valacyclovir (Valtrex) caplets taken at the first sign of an outbreak or placebo. The dosing was repeated 12 hours later. Polymerase chain reaction (PCR) swabs were collected every 12 hours starting at the first sign of outbreak and continuing for 10 days. Both groups had a history of cold sores for an average of 28 years and an average of four cold sores in the previous 12 months.

Patients receiving valacyclovir experienced fewer days of shedding than did the placebo group (1.8 vs. 4 days). A comparison of the log HSV-1 DNA copies detected by PCR over time, using the average area under the curve (AUC), showed significantly less shedding from the valacyclovir-treated patients than from the placebo-treated patients (average AUC 1.1 vs. 2.2).

The study's findings are important because information about the natural history of oral HSV-1 shedding and the impact of antivirals may help to reduce transmission rates, Dr. Gilbert said. Dr. Gilbert is a member of the speakers' bureau for GlaxoSmithKline Inc., which manufactures Valtrex and provided 50% of the funding for the study.

NEW ORLEANS — Treatment with once-daily, high-dose valacyclovir significantly decreases the duration and quantity of oral herpes simplex virus-1 shedding associated with recurrent herpes labialis, according to data from a randomized study.

Oral shedding, either associated with known outbreaks of herpes labialis or, perhaps more importantly, during asymptomatic periods, is the presumed mode of transmission of herpes simplex virus-1 (HSV-1), Stan C. Gilbert, M.D., said in a poster presentation at the annual meeting of the American Academy of Dermatology.

HSV-1 causes gingivostomatitis in infants and children and recurrent cold sores in most people. It also has become the primary cause of genital herpes in the majority of cases among young adults. Recurrent herpes labialis (RHL) affects up to 40% of HSV-1-seropositive adults.

Research has shown oral shedding associated with episodes of RHL lasting from 1 to 8 days. But the studies are rare and have relied mostly on viral cultures, according to Dr. Gilbert, of the University of Washington, Seattle.

His study randomized 64 adults with a history of three or more RHL episodes a year to four 500-mg valacyclovir (Valtrex) caplets taken at the first sign of an outbreak or placebo. The dosing was repeated 12 hours later. Polymerase chain reaction (PCR) swabs were collected every 12 hours starting at the first sign of outbreak and continuing for 10 days. Both groups had a history of cold sores for an average of 28 years and an average of four cold sores in the previous 12 months.

Patients receiving valacyclovir experienced fewer days of shedding than did the placebo group (1.8 vs. 4 days). A comparison of the log HSV-1 DNA copies detected by PCR over time, using the average area under the curve (AUC), showed significantly less shedding from the valacyclovir-treated patients than from the placebo-treated patients (average AUC 1.1 vs. 2.2).

The study's findings are important because information about the natural history of oral HSV-1 shedding and the impact of antivirals may help to reduce transmission rates, Dr. Gilbert said. Dr. Gilbert is a member of the speakers' bureau for GlaxoSmithKline Inc., which manufactures Valtrex and provided 50% of the funding for the study.