Seborrheic Dermatitis

September 25, 2017

Aclaris Therapeutics reported results of a phase II trial evaluating two concentrations (40% and 32.5%) of its drug candidate A-101 for the treatment of facial seborrheic keratosis (SK) lesions. In the randomized, double-blind, vehicle-controlled trial to evaluate A-101, the 40% and 32.5% concentrations were each compared to vehicle (placebo) in a total of 119 patients. Greater magnitude of effect was observed with the A-101 40% concentration than the 32.5% concentration when each was compared to vehicle. At day 106, the target lesion was clear or near clear in 68% of patients in the A-101 40% group, 62% of patients in the A-101 32.5% group and 5% of patients in the vehicle group. Improvements compared to vehicle were seen after just one treatment, but most patients received a second treatment in accordance with the study protocol. In the trial, A-101 achieved statistical significance in clearing SK lesions on the face in a dose-related fashion. A-101 was well-tolerated at both concentrations studied. The FDA’s Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) is December 24, 2017. If approved, A-101 40% would be the first FDA approved medication for SK.

August 25, 2008

Moberg Derma released mixed results from a phase III trial of K-301 for the treatment of seborrheic dermatitis. This randomized, double-blind, placebo-controlled study enrolled 201 subjects with mild-to-moderate disease, in Sweden. The subjects received placebo or K-301 applied to the affected area on the scalp once daily for four weeks. The primary endpoint, a reduction in the degree of erythema and scaling after four weeks of treatment, did not attain statistical significance over placebo. However, K-301 was significantly superior to placebo for several other key efficacy endpoints, including a marked effect on the degree of scaling after two and four weeks of treatment and the patient's and the doctor's global assessment of efficacy. No serious adverse events were reported. Based on the results, Moberg Derma plans to move forward with the development of K-301.

September 17, 2007

Moberg Derma issued positive results from a phase II trial of K301 for the treatment of seborrheic dermatitis of the scalp. This randomized, double-blind, placebo-controlled study enrolled 98 subjects in Sweden. Subjects received placebo or one of two doses of K301 applied topically once daily for the first four weeks followed by four weeks of maintenance treatment. The primary endpoint was the degree of erythema and desquamation after four weeks. Results demonstrated that 76% of subjects who received the most efficacious formulation of K301 had a positive response to the treatment, compared to 40% for placebo. Treatment was well tolerated, with adverse events similar to placebo. Based on the results Moberg plans to initiate a phase III trial of K301 in Q4 of 2007.