|The following article is part of conference coverage from the 2018 Fall Clinical Dermatology Conference in Las Vegas, Nevada. Dermatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in dermatology. Check back for the latest news from Fall Clinical Derm 2018.|
At the 37th Fall Clinical Dermatology Conference, researchers from Foamix Pharmaceuticals presented phase 3 data showing that FMX101, a topical minocycline 4% foam, was safe and effective for the treatment of moderate to severe acne vulgaris.
Currently, oral minocycline and doxycycline are first-line therapies for this condition but are associated with potentially serious systemic adverse effects. FMX101 is the first topical formulation of minocycline that has proven effective and well-tolerated in a phase 2 clinical trial and two double-blind, phase 3 studies (FX2014-04 and FX2014-05).
The third phase 3 study (FX2017-22) was intended to further assess the safety and efficacy of daily FMX101 4% application compared with vehicle foam over 12 weeks in the treatment of moderate to severe acne vulgaris in 1507 patients.
Study patients included men and nonpregnant women aged 9 years and older with moderate to severe acne (IGA score 3/4). The co-primary endpoints included absolute change from baseline in inflammatory lesion count at week 12 and IGA treatment success at week 12, defined by score of 0 (clear) or 1 (almost clear) with at least a 2 grade decrease from baseline.
The data showed patients in the FMX101 4% arm had a statistically significantly greater reduction in the number of inflammatory lesions from baseline vs the vehicle treatment group (-16.93 vs -13.40; P <.0001). Also, a statistically significantly greater proportion of patients achieved IGA treatment success with FMX101 4% vs the vehicle group (30.8% vs 19.6%; P <.0001) at week 12.
Treatment with FMX101 4% also led to a statistically significantly higher proportion of patients in the absolute change of non-inflammatory lesion count (secondary endpoint) and percentage change from baseline to week 12 in inflammatory lesions.
With regard to safety, 26.2% of FMX101 4% patients and 24.5% of vehicle foam patients experienced any treatment-emergent adverse events (TEAEs); the most frequent adverse event was upper respiratory tract infection. Serious TEAEs were seen in 0.1% and 0.5% of FMX101 4% and vehicle foam groups, respectively.
Study authors concluded that the study met both co-primary endpoints and the safety profile of FMX101 4% proved consistent with that established in the FX2014-04 and FX2014-05 studies.
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Raoof J, Hooper D, Moore A, et al. FMX101 4% topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: efficacy and safety from a phase 3 randomized, double-blind, vehicle-controlled study. Presented at: 2018 Fall Clinical Dermatology Conference. October 18-21, 2018; Las Vegas, NV.