Live Blog: Product Theater with Allergan – Aczone Gel – Hilary Baldwin, MD
In this live blog from the 12th Annual SDPA conference in Indianapolis, Hilary Baldwin, MD, presented a product theater from Allergan on Aczone Gel. Here are some of the highlights.
Aczone (dapsone) Gel 5% is indicated for the topical treatment of acne vulgaris. Aczone Gel is not an antibiotic.
Pivotal phase 3 study was conducted with 3,010 patients. Vehicle gel was applied twice a day. Patients had to have 20-50 inflammatory lesions or 50-100 non-inflammatory lesions
41% of patients treated with Aczone Gel (n=1,506) had minimal or no acne at 12 weeks, compared to 33% in the control group (n=1,504). In clinical trials the majority of side effects with Aczone Gel were mild to moderate, and included oiliness, peeling, dryness, and reddening where applied. Patients treated with ACZONE experienced reductions in lesion contra from baseline at week 12.
Efficacy by Gender:
Women in the study did significantly better with dapsone. Girls did better with the active and the vehicle: providers surmised that this could possibly be related to compliance. However, boys were shown to have more side effects overall. Therefore some providers think that side effects may not be related to where the acne was located by gender.
12-month study was done with 506 patients. Participants treated face twice a day. After 3 months they could add concomitant systemic or topical acne meds. Participants who used Aczone had same amount of side effects after 12 months, as did participants who were on placebo. Only 2% of participants discontinued Aczone during study due to side effects or rash, dryness, peeling. Efficacy: reduction of inflammatory lesions was significant
Important Safety Information:
Aczone is not for patients under 12 years of age. Most common adverse reactions (incidence ≥ 10%) are oiliness/peeling, dryness and erythema at the application site. The following are seen with oral dapsone treatment: Hematological Effects (5.1), Peripheral Neuropathy (5.2), Skin Reactions (5.3). Because of hematological effects: don’t combine with oral dapsone or anti-malarial medications.