Foamix announces completion of enrollment in phase II clinical trial of minocycline foam to treat papulopustular rosacea

Papulopustular rosacea is a chronic skin disorder characterized by facial redness and inflammatory lesions. It affects more than 16 million people in the U.S. alone. The most common treatments for rosacea are topical therapies such as metronidazole and azelaic acid, as well as the oral antibiotics minocycline and doxycycline.

"We are pleased to have reached full enrollment of our Phase 2 study earlier than we originally anticipated," said Dov Tamarkin, PhD, Chief Executive Officer of Foamix Pharmaceuticals.

"There is a significant unmet need for safe and effective alternatives for the treatment of rosacea. We believe FMX103 has the potential to offer meaningful benefits over the current standard of care, and we look forward to receiving the results of this study later this year."

In this Phase 2 double-blind, randomized, placebo-controlled trial, 233 patients have been enrolled in 18 sites throughout Germany. Patients were randomized to receive FMX103 (3% minocycline foam), FMX103 (1.5% minocycline foam) or vehicle foam over 12 weeks, followed up by a 4-week post-treatment evaluation.

The primary endpoints are safety, tolerability and efficacy in the treatment of moderate-to-severe papulopustular rosacea. Foamix expects to develop FMX103 in the U.S. under the FDA’s 505(b)(2) regulatory pathway.

Foamix expects to report top-line results from this Phase 2 study by the end of the year.

Papulopustular rosacea is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.

It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that adversely affect quality of life. Rosacea is most frequently seen in adults between 30 and 50 years of age.

Although the exact root cause of rosacea remains unknown, both genetic and environmental factors are thought to have an impact on causing this disease.