Ortho Dermatologics, a Bausch Health company, announced the results of its second Phase 3 trial (NCT04214652) investigating the safety and efficacy of IDP-126 (Ortho Dermatologics) for the treatment of acne vulgaris in patients 9 years of age and older.1
This study, a phase 3, multicenter, randomized, double-blind, vehicle-controlled trial, met all co-primary endpoints at week 12.
Endpoints were absolute change from baseline in inflammatory lesion count and non-inflammatory lesion count, and the percentage of patients who achieved treatment success. Treatment success was defined as clear or nearly clear skin in the Global Assessor Severity Score (EGSS).
“Most acne patients are treated with a regimen that includes multiple drug classes due to the complicated nature of the disease. This approach can be burdensome for patients and exacerbate poor adherence rates, which are already weak for acne patients when using simple regimens,” said Scott Hirsch, President of Ortho Dermatologics and Senior Vice President and Chief Strategy Officer of Bausch Health, Laval, Canada. “Dermatologists are asking for decades a triple combination therapy to help them combat this problem. Ortho Dermatologics has achieved a technological breakthrough with IDP-126 to address this need, which, if approved, will provide the first and only treatment option triple combination to help patients struggling with acne.
The study results were based on 193 patients, aged 9 years and older, who participated in the trial. Patients were randomized to receive IDP-126 gel or vehicle once daily for 12 weeks.
Of both treatment arms, 50.5% of the IDP-126 arm achieved clear or nearly clear EGSS compared to 20.5% of the vehicle. Some patients have obtained treatment benefits as early as 2 weeks.
Treatment-emergent adverse events (TEAEs) that were reported in less than 2% of patients, such as application site pain, dryness, irritation, erythema, exfoliation, and xerosis.
“The impressive results of this second Phase 3 study for IDP-126 are consistent with the results seen in the findings of the first Phase 3 study, especially the high efficacy results. I am encouraged that, if approved, IDP-126 will provide a triple combination therapy – three active ingredients in one product – that could simplify the treatment regimen and have a significant impact on my acne patients. said Linda Stein Gold, MD, director, Clinical Research in Dermatology, Henry Ford Health System, Detroit, Michigan.
If approved, IDP-126 would be the first treatment combining a retinoid, an antibacterial and a topical antibiotic.
1. Marks K. Ortho Dermatologics announces the first statistically significant results from the second pivotal phase 3 clinical trial evaluating idp-126 gel in acne vulgaris. Published online April 27, 2021.