With Linda Stein Gold, MD
Investigational triple combination gel achieves positive results in second phase 3 trial
“Acne management guidelines recommend combining benzoyl peroxide with an antibiotic and a topical retinoid for treatment of moderate to severe acne. The investigational agent IDP-126 provides these three medications in a topical gel, and its efficacy and safety for treating moderate to severe acne has now been demonstrated in a second phase 3 trial,” said Linda Stein Gold, MD. “IDP-126 is the first triple combination topical product that has been studied for the treatment of moderate to severe acne. With IDP-126, patients can have the benefit of multimodal therapy and a simplified regimen involving once-daily application of a single product.”
The active ingredients in IDP-126—benzoyl peroxide, clindamycin phosphate, and adapalene—are combined in an optimized, cosmetically elegant, easy to spread gel formulation, said Dr. Stein Gold, Director of Dermatology Clinical Research, and Head, Division of Dermatology, Henry Ford Health System, Detroit, Michigan.
“Benzoyl peroxide has antibacterial activity, minimizes emergence of bacterial resistance to clindamycin, and is compatible with adapalene,” said Dr. Stein Gold. “Each of the active ingredients in IDP-126 is micronized, which enhances bioavailability by improving contact with the skin and thereby allowing for enhanced penetration.”
Clinical trial program
A phase 2 clinical trial of IDP-126 compared the investigational agent to the dual fixed combination of each of its components and its vehicle. The results of the primary outcome analysis, which considered absolute change from baseline to week 12 in mean inflammatory lesion counts, showed that the triple combination gel was superior to all of its comparators, and the differences favoring IDP-126 were highly statistically significant.
“In addition, the investigational drug was well-tolerated, and side effects associated with its use were mainly mild to moderate in severity,” said Dr. Stein Gold.
The phase 3 program for IDP-126 comprised two multicenter, double-blind trials comparing the investigational triple combination gel to its vehicle. Eligible patients were ≥ 9 years of age with moderate to severe acne defined by a rating of 3 or 4 in the five-point Evaluator’s Global Severity Score (EGSS). Patients were also required to have 30 to ≤ 100 inflammatory acne lesions, > 35 to ≤ 150 comedonal lesions, and ≤ 2 facial nodules.
Participants were randomized 2:1 to treatment with IDP-126 or vehicle and used their assigned study medication once daily for 12 weeks. A total of 363 patients were enrolled across the two equally sized trials.
Both studies met their primary efficacy endpoints that analyzed absolute change from baseline to week 12 in inflammatory lesion counts, absolute change from baseline to week 12 in non-inflammatory lesion counts, and the percentage of subjects achieving at least a 2-grade reduction from baseline and an EGSS score of 0 (clear) or 1 (almost clear) at week 12.
“The analyses demonstrated highly statistically significant differences favoring IDP-126 versus vehicle for improving inflammatory lesion counts, comedonal lesion counts, and achieving EGSS success. Topline results from the second phase 3 trial showed EGSS success rates of 50.5% for the IDP-126 group versus 20.5% for vehicle,” Dr. Stein Gold said.
“Benefits of treatment with IDP-126 were seen as early as at 2 weeks, which was the time of the first follow-up visit.”
IDP-126 was again well-tolerated. According to information released on the second phase 3 trial, the most common adverse events reported in ≥ 2% or more of subjects were application site pain, irritation, erythema, and exfoliation.
A recently launched phase 2 study is comparing IDP-126 gel to its vehicle and Epiduo Forte Gel (0.3% adapalene/2.5% benzoyl peroxide) in patients ≥ 12 years of age with moderate to severe acne.
By Cheryl Guttman Krader
Disclosure: Dr. Stein Gold is an investigator/consultant and or speaker for Ortho Derm, Galderma, Vyne, Sun, Novartis, Cassiopeia, Sol-Gel and Almirall.
Linda Stein Gold, MD lstein1@hfhs.org