Two recent multi-center, phase 3, randomized double-blind trials showed a topical minocycline foam, FMX101 4%, to be effective in the treatment of moderate to severe acne vulgaris, a chronic inflammatory skin disease characterized by inflammatory and noninflammatory lesions, and results were published in the Journal of the American Academy of Dermatology.
The study population (N=961) comprised Study 04 (NCT02815267; N=466) and Study 05 (NCT028815280; N=495) participants whose average ages were 20.3 and 20.6, respectively. The study populations were mostly women with moderate to severe facial acne. The participants Investigator’s Global Assessment (IGA) scores for moderate acne were 84.1% for Study 04 and 89.7% for Study 05. For severe acne, IGA scores for Study 04 were 15.9% and for Study 05 were 10.3%. The participants received either the vehicle control or FMX101 4% to apply topically daily (preferably in evening) for 12 weeks. Efficacy and safety assessment were conducted at weeks 3, 6, 9, and 12. The initial 12-week period was followed by a 40-week open-label phase to facilitate further studies on efficacy and safety.
FMX101 4% was more efficacious (at week 12) in the reduction of inflammatory lesions (coprimary end point) from baseline in both Study 04 (-14.13 vs -11.19; least-squares means [LSM] difference: 2.80; 95% CI, 0.72-4.88; P =.0083) and Study 05 (-13.46 vs -10.70; LSM difference: 3.15; 95% CI, 0.95-5.35; P =.0051) in comparison to the vehicle control. In the treatment of the second coprimary end point (achieving IGA scores of “clear” or “almost clear” with at least a 2-grade improvement), FMX101 4% was more effective in Study 05 (14.66% vs 7.89%; risk ratio: 1.88; 95% CI, 1.02-3.46; P=.0424) compared with vehicle control.
FMX101 4% reduced inflammatory lesions at week 3 in both studies and maintained this reduction through the study period. FMX101 4% significantly reduced noninflammatory lesions (at week 12) in both Study 04 (-16.45 vs -10.30; LSM difference: 5.49; 95% CI, 1.73-9.25; P=.0042) and Study 05 (-13.20 vs -7.00; LSM difference: 6.79; 95% CI, 0.58-13.00; P =.0320) in comparison to vehicle control. Treatment-emergent adverse events identified in one or both study arms included headache, nasopharyngitis, upper respiratory infection, ligament sprain, blood creatinine phosphokinase increase, nausea, and vomiting.
Investigators note 2 study limitations, as long-term efficacy and safety outcomes were insufficient.
Taken together, the researchers showed evidence for FMX101 4% as a potential topical agent to treat moderate to severe acne vulgaris in a young population.
Disclosures: Clinical trials NCT02815267and NCT02815280 were sponsored by Foamix Pharmaceuticals. Please refer to original reference for a full list of authors’ disclosures.
Gold LS, Dhawan S, Weiss J, Draelos ZD, Ellman H, Stuart IA. A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: results of two randomized, double-blind, phase 3 studies [published online August 18, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.08.020