USA: The fixed-combination IDP-126 gel demonstrated promising results as the first triple-combination product for acne treatment in children and adolescents aged 9 to 17 years, a recent study published in Pediatric Dermatology has shown. IDP-126 achieved significantly greater success rates than dyad combinations and vehicle.
Topical clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel (IDP-126) showed superior efficacy to dyad component and vehicle in pediatric patients with moderate-to-severe acne, with over half of IDP-126-treated trial patients achieving treatment success. IDP-126 was well-tolerated and significantly improved participants' quality of life assessments.
"The safety and efficacy profile of IDP-126—the only fixed-combination acne medication in development containing three recommended treatments for once-daily use—shows its potential as an option for effective acne treatment," the researchers wrote.
In the post hoc analysis of a phase 2 trial, Lawrence F. Eichenfield, San Diego School of Medicine, La Jolla, California, USA, and colleagues investigated the safety and efficacy of IDP-126 in adolescents and children with moderate-to-severe acne.
Participants ≥9 years of age with moderate-to-severe acne were eligible in a randomized, double-blind phase 2 study. They were randomized in the ratio of 1:1:1:1:1 for 12 weeks to once-daily IDP-126, one of three dyad combination gels, or vehicle gel.
The post hoc analysis of 394 pediatric participants included children and adolescents up to 17. Assessments included noninflammatory/inflammatory lesion counts, treatment success, Acne-QoL (Acne-Specific Quality of Life) questionnaire, cutaneous safety/tolerability, and treatment-emergent adverse events (TEAEs).
The study revealed the following findings:
At Week 12, treatment success rates were significantly greater with IDP-126 (55.8%) than with vehicle (5.7%;) or any of the dyad combinations (range: 30.8%–33.9%).
Lesion reductions with IDP-126 were also significantly greater than with vehicle (inflammatory: 78.3% versus 45.1%; noninflammatory: 70.0% versus 37.6%) and 9.2%–16.6% greater than with any of the dyad combinations.
Increases (improvements) from baseline in Acne-QoL domain scores were generally more significant with IDP-126 than in any other treatment group.
The most common treatment-related TEAEs across treatment groups were application site pain and dryness. Most treatment-related TEAEs were of mild-to-moderate severity.
Results from the post hoc analysis showed that pediatric participants treated with IDP-126, a novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% polymeric gel, experienced rapid reductions in noninflammatory and inflammatory lesion counts and treatment success rates of over 50%, higher than for those treated with vehicle or any of three dyad combination gels.
Reference:
Eichenfield LF, Stein Gold L, Kircik LH, Werschler WP, Beer K, Draelos ZD, Tanghetti EA, Papp KA, Baldwin H, Lain E, Sadick N, Gooderham MJ, Konda A. Triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel for moderate-to-severe acne in children and adolescents: Randomized phase 2 study. Pediatr Dermatol. 2023 Mar 22. doi: 10.1111/pde.15283. Epub ahead of print. PMID: 36949579.