An experimental triple therapy has shown improvement of acne inflammation and lesions in a Phase 3 trial, Ortho Dermatologics announced in a press release.
The 12-week, multi-center, randomized, double-blind, vehicle-controlled trial evaluated the safety, tolerability and efficacy of IDP-126, a combination of retinoids, antibacterials and topical antibiotics, in 193 patients randomized to receive either the treatment gel or a vehicle gel once daily on the face.
“This is the first time that we have a triple combination in a single product. It contains clindamycin, benzoyl peroxide and adapalene in gel form ”. Linda Stein Gold, MD, one of the study’s investigators told Healio.
Treatment success, defined as a two-degree reduction from baseline and fair or near fair skin in the Rater’s Overall Severity Score, was reported in 50.5% of people in the IDP- group. 126 compared to 20.5% in the vehicle groupP = .001). Other outcomes that were met included an absolute change from baseline in inflammatory lesion count and absolute change from baseline in non-inflammatory lesion count (both P <.001>
Treatment-related adverse events that were reported in more than 2% of patients included pain at the application site, dryness, irritation, erythema, exfoliation and xerosis, the statement said.
“This is one of the highest performance we have seen with topicals,” said Stein Gold. “This could potentially be the best topical in its class for the treatment of acne on a diet made easy.”
The company plans to submit a new drug application for IDP-126 to the FDA in the second half of 2022, the statement said.
“If we can simplify a treatment regimen, it is much easier for patients to work through that treatment in their daily routine,” said Stein Gold.