Topical minocycline foam safe for long-term rosacea treatment

A topical minocycline foam was safe and well tolerated for long-term papulopustular rosacea treatment, according to study findings presented at the American Academy of Dermatology virtual meeting.

“Oral tetracyclines, such as doxycycline and minocycline, are among the common therapies that are used for treating the disorder with oral, sub-microbial doxycycline currently approved for this indication,” Linda Stein Gold, MD, of Henry Ford Health System, and colleagues wrote. “However, these agents have been associated with antibiotic resistance, adverse side effects, such as gastrointestinal upset and permanent hyperpigmentation, and following treatment cessation, the tendency for disease relapse is high.”

In an open-label, multicenter 40-week extension study, the long-term safety, tolerability and efficacy of FMX103 1.5% (Foamix Pharmaceuticals) topical foam were evaluated in 505 subjects with moderate to severe facial papulopustular rosacea from two prior studies.

Treatment-emergent adverse events occurred in 39.9% of 504 subjects, but they were overall well tolerated at week 52.

FMX103 1.5% was associated with a reduction in inflammatory lesions (–80.9% in the vehicle group that was switched to FMX103 vs. –83% in the group that received FMX103 only). At the study conclusion, 81.6% of the FMX103/FMX103 patients and 76% of the vehicle/FMX103 patients achieved treatment success, with more than 80% of all subjects reporting they were satisfied or very satisfied with the treatment.

“FMX103 1.5% appeared to be safe and well tolerated for the long-term treatment of papulopustular rosacea,” Stein Gold and colleagues wrote. “Throughout 52 weeks of treatment, FMX103 1.5% continued to be associated with a decreasing number of inflammatory lesions, as well as with improvement in overall disease severity.”