AT SDEF LAS VEGAS DERMATOLOGY SEMINAR
In the future, topical agents that target sebum production could play a greater role in acne management.
Linda F. Stein Gold, MD, director of dermatology research at the Henry Ford Health System in Detroit highlighted several studies of these investigational therapies in a presentation on acne at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Sebum reduction has emerged as a focus of acne treatment, she said, with the following trio of candidates in the pipeline:
• SB204, a topical agent that releases nitric oxide.
• DRM01, a topical sebum inhibitor that inhibits acetyl coenzyme-A carboxylase, an enzyme involved in the synthesis of fatty acids.
• Cortexolone 17a-propionate (CB-03-01) 1% cream, a topical antiandrogen.
A 4% gel formulation of SB204 once a day was compared with a vehicle, also applied topically once a day, in a pair of phase 3 randomized, multicenter pivotal trials of 2,639 patients aged 9 years and older with moderate to severe acne, Dr. Stein Gold said. At 12 weeks, the absolute change in number of noninflammatory lesions among those treated with SB204 was a reduction by 15.4 vs. 13.4 among those treated with a vehicle in one study (P = .03) and by 14.9 vs. 12.3 with a vehicle in the other study (P = .001). The absolute change in the number of inflammatory lesions among those using SB204 in the first study was not significantly different from those seen among patients using the vehicle (a reduction of 12.1 vs. 11.1, respectively) but was significant in the second study (a reduction of 12.9 vs. 10.6 for vehicle; P less than .001).
No new safety signals were observed and treatment was “generally safe and well tolerated,” with fewer than 2% of patients discontinuing treatment because of treatment-emergent adverse events, she noted.
In a phase 2 study, those treated with a 4% formulation of SB204 had a significant reduction in inflammatory and noninflammatory lesions at 12 weeks, with mild local irritation as the main adverse effect, she said ( J. Drugs Dermatol. 2016 Dec 1;15:1496-527 ). The treatment was generally safe and well tolerated, said Dr. Stein Gold, one of the study authors.
In a phase 2 randomized, multicenter, double-blind study of 108 patients with moderate or severe acne, she continued, those treated with DRM01 7.5% applied to the face twice a day for 12 weeks, those treated with DRM01 showed significant improvement across all efficacy measures at 12 weeks, including a significantly greater reduction in both inflammatory and noninflammatory lesions, and on measures of investigator’s global assessment – after 12 weeks of twice-daily treatment. Treatment was well tolerated, and no serious adverse events related to the treatment were reported, Dr. Stein Gold said.
(In October, the manufacturer, Dermira, announced that patient enrollment in two phase 3 trials of DRM01– now known as olumacostat glasaretil – in patients aged 9 years and older with facial acne had been completed.)
Phase 3 studies of cortexolone 17a-propionate (CB-03-01) 1% cream are underway, Dr. Stein Gold said.
Dr. Stein Gold disclosed relationships with multiple companies including Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, Promius, Anacor, and Medimetriks.
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