Triple combination acne therapy shows positive phase 3 results
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An investigational triple combination therapy showed statistically significant improvement in acne inflammation and lesions in a phase 3 trial, Ortho Dermatologics announced in a press release.
The multicenter, randomized, double-blind, vehicle-controlled 12-week trial assessed the safety, tolerability and efficacy of IDP-126, a combination retinoid, antibacterial and antibiotic topical medication, in 193 patients randomly assigned to receive either the treatment gel or a vehicle gel once daily on the face.
“This is the first time we have a triple combination in one product. It has clindamycin, benzoyl peroxide and adapalene in a gel formulation,” Linda Stein Gold, MD, one of the study investigators, told Healio.
Treatment success, defined as a two-grade reduction from baseline and clear or almost clear skin in Evaluator’s Global Severity Score, was reported in 50.5% of those in the IDP-126 group compared with 20.5% in the vehicle group (P = .001). The other endpoints that were reached included absolute change from baseline in inflammatory lesion count and absolute change from baseline in non-inflammatory lesion count (both P < .001).
Treatment-emergent adverse events that were reported in more than 2% of patients included application site pain, dryness, irritation, erythema, exfoliation and xerosis, the release said.
“This is some of the highest efficacy we’ve seen with topical products,” Stein Gold said. “This could potentially be best-in-class topical for the treatment of acne with a simplified regimen.”
The company plans to submit a new drug application for IDP-126 to the FDA in the second half of 2022, according to the release.
“If we can simplify a treatment regimen, it makes it much easier for patients to work in that treatment into their daily routine,” Stein Gold said.
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