Dapsone Gel Effective for Acne

NEW ORLEANS — A 5% dapsone gel appears safe and effective in clearing both inflammatory and noninflammatory acne lesions and seems more effective with longer use, researchers said at the annual meeting of the American Academy of Dermatology.

Two phase III studies showed significant reductions in lesion count and very low rates of adverse events, all of which were mild and decreased with continued use of the medication. The most common application site side effects—sunburn, dryness, and rash—were reported by no more than 3% of patients.

The first study, by David C. Wilson, M.D., included 496 patients aged 12–44 years with mild to severe facial acne. The patients were randomized to either dapsone 5% gel (330 patients) or vehicle (166 patients), applied twice daily for 12 weeks. At baseline, the patients had a mean lesion count of 33 inflammatory lesions and 55 noninflammatory lesions.

Significant differences in lesion count reduction were apparent by week 4 of treatment, said Dr. Wilson, a dermatologist in private practice in Forest, Va. By week 12, success as measured by a Global Acne Assessment score of less than 2 occurred in about 28% of the treatment group and 19% of the placebo group.

“These results are similar to what we have seen in short-term trials of other agents,” Dr. Wilson said in a poster session at the meeting.

By the end of the study, patients treated with dapsone experienced greater mean reduction of both inflammatory lesions (37% vs. 26%) and noninflammatory lesions (32% vs. 22%) than did the vehicle-treated patients.

Pruritus, burning, and nonspecific site reaction were reported by less than 2% of patients and did not differ significantly between the groups. Headache, upper respiratory infection, and nasopharyngitis occurred in 6% or less of patients and did not differ significantly between groups.

An open-label study by Michael Maloney, M.D., examined the drug's long-term safety and efficacy in 506 patients with moderate to severe acne on the face, back, shoulders, and/or chest. The patients applied the gel twice daily to acne-involved areas for 12 months.

If acne cleared in one area, the gel was discontinued in that area. If it recurred, the gel was resumed.

At baseline, the mean lesion count was 48 inflammatory and 38 noninflammatory lesions.

Improvement was noted as early as 4 weeks. By 12 months, inflammatory lesions decreased a mean of 58%, noninflammatory lesions decreased a mean of 19.5%, and total lesion count decreased a mean of 49%.

Four patients (1%) dropped out of the study because of a lack of efficacy with the treatment.

The most common application site adverse events were dryness, rash, and sunburn; fewer than 3% of patients reported these.

The most common non-application site adverse events were headache (20%) and nasopharyngitis (15%).

A total of 11 patients (2%) dropped out because of adverse events.

Dapsone appears to exert both an anti-inflammatory and an antibiotic effect, said Dr. Mahoney, a dermatologist at Cherry Creek Research Inc., Denver, but its exact mechanism of action is unknown.

Both studies were sponsored by QLT USA Inc., of Fort Collins, Colo., and Astellas Pharma U.S. Inc., Deerfield, Ill. Neither investigator reported a financial interest in the product or company.

NEW ORLEANS — A 5% dapsone gel appears safe and effective in clearing both inflammatory and noninflammatory acne lesions and seems more effective with longer use, researchers said at the annual meeting of the American Academy of Dermatology.

Two phase III studies showed significant reductions in lesion count and very low rates of adverse events, all of which were mild and decreased with continued use of the medication. The most common application site side effects—sunburn, dryness, and rash—were reported by no more than 3% of patients.

The first study, by David C. Wilson, M.D., included 496 patients aged 12–44 years with mild to severe facial acne. The patients were randomized to either dapsone 5% gel (330 patients) or vehicle (166 patients), applied twice daily for 12 weeks. At baseline, the patients had a mean lesion count of 33 inflammatory lesions and 55 noninflammatory lesions.

Significant differences in lesion count reduction were apparent by week 4 of treatment, said Dr. Wilson, a dermatologist in private practice in Forest, Va. By week 12, success as measured by a Global Acne Assessment score of less than 2 occurred in about 28% of the treatment group and 19% of the placebo group.

“These results are similar to what we have seen in short-term trials of other agents,” Dr. Wilson said in a poster session at the meeting.

By the end of the study, patients treated with dapsone experienced greater mean reduction of both inflammatory lesions (37% vs. 26%) and noninflammatory lesions (32% vs. 22%) than did the vehicle-treated patients.

Pruritus, burning, and nonspecific site reaction were reported by less than 2% of patients and did not differ significantly between the groups. Headache, upper respiratory infection, and nasopharyngitis occurred in 6% or less of patients and did not differ significantly between groups.

An open-label study by Michael Maloney, M.D., examined the drug's long-term safety and efficacy in 506 patients with moderate to severe acne on the face, back, shoulders, and/or chest. The patients applied the gel twice daily to acne-involved areas for 12 months.

If acne cleared in one area, the gel was discontinued in that area. If it recurred, the gel was resumed.

At baseline, the mean lesion count was 48 inflammatory and 38 noninflammatory lesions.

Improvement was noted as early as 4 weeks. By 12 months, inflammatory lesions decreased a mean of 58%, noninflammatory lesions decreased a mean of 19.5%, and total lesion count decreased a mean of 49%.

Four patients (1%) dropped out of the study because of a lack of efficacy with the treatment.

The most common application site adverse events were dryness, rash, and sunburn; fewer than 3% of patients reported these.

The most common non-application site adverse events were headache (20%) and nasopharyngitis (15%).

A total of 11 patients (2%) dropped out because of adverse events.

Dapsone appears to exert both an anti-inflammatory and an antibiotic effect, said Dr. Mahoney, a dermatologist at Cherry Creek Research Inc., Denver, but its exact mechanism of action is unknown.

Both studies were sponsored by QLT USA Inc., of Fort Collins, Colo., and Astellas Pharma U.S. Inc., Deerfield, Ill. Neither investigator reported a financial interest in the product or company.

NEW ORLEANS — A 5% dapsone gel appears safe and effective in clearing both inflammatory and noninflammatory acne lesions and seems more effective with longer use, researchers said at the annual meeting of the American Academy of Dermatology.

Two phase III studies showed significant reductions in lesion count and very low rates of adverse events, all of which were mild and decreased with continued use of the medication. The most common application site side effects—sunburn, dryness, and rash—were reported by no more than 3% of patients.

The first study, by David C. Wilson, M.D., included 496 patients aged 12–44 years with mild to severe facial acne. The patients were randomized to either dapsone 5% gel (330 patients) or vehicle (166 patients), applied twice daily for 12 weeks. At baseline, the patients had a mean lesion count of 33 inflammatory lesions and 55 noninflammatory lesions.

Significant differences in lesion count reduction were apparent by week 4 of treatment, said Dr. Wilson, a dermatologist in private practice in Forest, Va. By week 12, success as measured by a Global Acne Assessment score of less than 2 occurred in about 28% of the treatment group and 19% of the placebo group.

“These results are similar to what we have seen in short-term trials of other agents,” Dr. Wilson said in a poster session at the meeting.

By the end of the study, patients treated with dapsone experienced greater mean reduction of both inflammatory lesions (37% vs. 26%) and noninflammatory lesions (32% vs. 22%) than did the vehicle-treated patients.

Pruritus, burning, and nonspecific site reaction were reported by less than 2% of patients and did not differ significantly between the groups. Headache, upper respiratory infection, and nasopharyngitis occurred in 6% or less of patients and did not differ significantly between groups.

An open-label study by Michael Maloney, M.D., examined the drug's long-term safety and efficacy in 506 patients with moderate to severe acne on the face, back, shoulders, and/or chest. The patients applied the gel twice daily to acne-involved areas for 12 months.

If acne cleared in one area, the gel was discontinued in that area. If it recurred, the gel was resumed.

At baseline, the mean lesion count was 48 inflammatory and 38 noninflammatory lesions.

Improvement was noted as early as 4 weeks. By 12 months, inflammatory lesions decreased a mean of 58%, noninflammatory lesions decreased a mean of 19.5%, and total lesion count decreased a mean of 49%.

Four patients (1%) dropped out of the study because of a lack of efficacy with the treatment.

The most common application site adverse events were dryness, rash, and sunburn; fewer than 3% of patients reported these.

The most common non-application site adverse events were headache (20%) and nasopharyngitis (15%).

A total of 11 patients (2%) dropped out because of adverse events.

Dapsone appears to exert both an anti-inflammatory and an antibiotic effect, said Dr. Mahoney, a dermatologist at Cherry Creek Research Inc., Denver, but its exact mechanism of action is unknown.

Both studies were sponsored by QLT USA Inc., of Fort Collins, Colo., and Astellas Pharma U.S. Inc., Deerfield, Ill. Neither investigator reported a financial interest in the product or company.