Minocycline, adapalene combination foam shows good results in acne treatment
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Minocycline and adapalene combination foam showed improvement over vehicle and an advantage over the individual components in treating moderate to severe acne, according to a phase 2 study presented at Maui Derm for Dermatologists.
“A fixed combination of minocycline 3% and adapalene 0.3%, FCD105, has been developed as a novel topical foam for the treatment of moderate to severe acne,” James Q. Del Rosso, DO, and colleagues wrote in the poster. “Both of these molecules are used individually or in combination with other agents (eg, benzoyl peroxide) in FDA-approved treatments for acne although a retinoid/tetracycline topical formulation had not been evaluated in clinical studies prior to this study and may offer an improved treatment option for patients with moderate to severe acne.”
Del Rosso and colleagues conducted a randomized, multicenter, double-blind, vehicle-controlled phase 2 study of patients aged 12 years and older who had 20 to 50 inflammatory lesions, 25 to 100 noninflammatory lesions, an Investigator’s Global Assessment score of 3/4, and two or fewer active face nodules. The 447 subjects (white, 70.7%; women, 61.1%; mean age, 21.3 years) in the study had an average of 30.6 inflammatory lesions and 48.1 noninflammatory lesions at baseline. The study’s primary efficacy endpoints included the change in the number of inflammatory and noninflammatory lesions at week 12, as well as achieving an IGA score of 0 or 1.
At week 12, 35.9% of the FCD105 group reached the IGA score outcome compared with 15.7% of the vehicle group (P = .0003). The FCD105 group also had greater decreases in the percentage change in inflammatory lesions (–64.1% vs. –50.9%; P = .0013) and noninflammatory lesions (–51.0 vs. –45.9) compared with the vehicle group.
There were few treatment-emergent adverse events, with no serious events reported.
“These data are supportive to continue the development of FCD105 into phase 3 clinical evaluation for the treatment of moderate to severe acne vulgaris,” the researchers wrote.
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Del Rosso JQ, et al. A prospective, multicenter, randomized, double-blind, vehicle-controlled phase 2 study to evaluate the safety and efficacy of a combination of 3% minocycline and 0.3% adapalene topical foam formulation for the treatment of moderate-to-severe acne. Presented at: Maui Derm for Dermatologists; Jan. 25-29, 2021; Maui, Hawaii (hybrid meeting).
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