Triple Combo Acne Gel Well-tolerated in Two Studies

The phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel also showed some efficacy.

A triple combination acne gel (IDP-126) was shown to be safe and effective in two phase 3 studies, according to a new analysis.

Researchers publishing in the Journal of the American Academy of Dermatology analyzed the results of two phase 3, double-blind, 12-week studies that randomized participants (aged 9 years and up) with moderate-to-severe acne (N=183; N=180) 2:1 to once-daily IDP-126 or vehicle gel. The co-primary endpoints were achievement of ≥2-grade reduction from baseline in Evaluator's Global Severity Score (EGSS) and clear/almost clear skin (treatment success) and change from baseline in inflammatory/noninflammatory lesion counts.

The analysis results showed that at 12 weeks, 49.6% and 50.5% of participants achieved treatment success with IDP-126 versus 24.9% and 20.5% with vehicle, respectively (P<0.01, both). Treatment with IDP-1126 was also associated with significant reductions in inflammatory/noninflammatory lesions compared to the vehicle group. The researchers reported that treatment-related adverse events were of mild to moderate severity. The researchers cited inter-observer bias/variation in acne severity ratings, limited duration of treatment, and population differences preventing generalization as study limitations.

"Once-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel confirmed its superior efficacy to vehicle gel over 12 weeks in participants with moderate-to-severe acne in 2 randomized, double-blind, vehicle-controlled clinical studies," the researchers wrote in the study. "IDP-126 also demonstrated a positive safety and tolerability profile. "With its simple treatment regimen containing 3 recommended acne treatments (benzoyl peroxide, a topical retinoid, and a topical antibiotic), IDP-126 is a potential new treatment option for acne."