IDP-126, a clindamycin phosphate comprising 1.2% benzoyl peroxide, 3.1% adapalene, and 0.15 polymeric mesh gel, is the first fixed-dose triple-combination formulation in development for acne.
During a randomized phase 2 study, researchers evaluated the safety, efficacy, and tolerability of the fixed-combination IDP-126 in children and adolescents with moderate-to-severe acne. The study included 394 participants between the ages of nine and 17. Participants were randomly assigned to either once-daily IDP-126 gel, one of three dyad combination gels, or vehicle gel for 12 weeks.
At week 12, those treated with IDP-126 gel saw a 55.8% success rate compared to both the dyad combinations (30.8%-33.9%) and vehicle (5.7%). In addition, those treated with IDP-126 gel saw a reduction in inflammatory lesions of 78.3% compared to 45.1% of those treated with vehicle. Similarly, non-inflammatory lesions were reduced by 70% with IDP-126 compared with 37.6% for vehicle.
The study also reported on quality of life, which found that those who received IDP-126 gel saw greater improvements in almost all acne-specific quality of life domains than any other treatment group.
Treatment-Emergent Adverse Events (TEAEs) were mostly mild to moderate in severity with the most common being pain at the application site and dryness. According to the researchers, no serious adverse events were related to the study drug.
Lawrence F. Eichenfield, MD, and his colleagues from the study concluded that “IDP-126 was well tolerated and led to meaningful improvements in participants’ quality of life assessments. The efficacy and safety profile of IDP-126—the only fixed-combination acne medication in development containing three recommended treatments for once-daily use, demonstrates its potential as an effective acne treatment option.”
- Eichenfield, LF, Stein Gold, L, Kircik, LH, et al. 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; 1- 8. doi:10.1111/pde.15283