Phase 3 Data on Anti-Androgen Acne Topical Shows Efficacy

Phase 3 Data on Clascoterone for Acne Vulgaris

On April 22, 2020, JAMA Dermatology published the results from two 12-week Phase 3 studies of clascoterone cream 1%, a potential first-in-class, topical acne treatment, targeting androgen-driven acne in both males and females.

The two identical, randomized, multicenter phase 3 studies—CB-03-01/25 and CB-3-01/26—evaluated the efficacy and safety of topical clascoterone cream, 1% vs. vehicle cream applied twice daily for 12 weeks in a total of 1,440 patients with facial acne vulgaris.

FDA Approves ARAZLO (Tazarotene) Lotion For Acne Vulgaris

FDA Approves Ortho's New Acne Topical

The U.S. Food and Drug Administration has approved the New Drug Application for Ortho Dermatologics’ ARAZLO (tazarotene) Lotion, 0.045%, for the topical treatment of acne vulgaris in patients nine years of age and older. ARAZLO is the first tazarotene acne treatment available in a lotion form, and has been shown to provide strong efficacy with favorable tolerability.

Novan Receives Additional Funding to Support Its Nitric Oxide-Based Therapies

Novan has entered into a common stock purchase agreement with Aspire Capital Fund, LLC, a Chicago-based institutional investor. The agreement provides additional financing to fund Novan’s nitric oxide technology platform, which has potential indications in dermatology, women’s health and gastroenterology. The company currently has four nitric oxide-based products with dermatologic indications in the pipeline, including SB204 for acne, SB206 for molloscum, SB208 for tinea pedis, and SB414 for the treatment of atopic dermatitis and psoriasis.

Sebacia Demonstrates 85 Percent Improvement in Acne at 12 Months

Sebacia Real World Results

Sebacia, a privately held, commercial-stage dermatology and aesthetics company, announced new results from its real-world study in Europe evaluating Sebacia Microparticles for treatment of acne. The study demonstrated an average 85 percent improvement in facial acne at 12 months.

Sebacia Microparticles were cleared in 2018 by the U.S. Food and Drug Administration (FDA) for use as an accessory to 1,064nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild-to-moderate inflammatory acne vulgaris.