First Triple-Combination Acne Drug Well Tolerated

The first triple-combination, fixed-dose topical for moderate to severe acne achieved treatment success in about half the participants in phase 2 and 3 studies, according to study results presented at the American Academy of Dermatology’s (AAD) annual meeting held March 25 to 29, 2022.

The phase 2 and 2 phase 3 double-blind, randomized, 12-week studies sought to determine the safety and efficacy of fixed-dose clindamycin 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel otherwise known as IDP-126. The phase 2 study included 741 participants and the phase 3 studies included 183 and 180 participants. Participants were aged 9 years and older; most were White women, and not Hispanic or Latinx, with an Evaluator’s Global Severity Score (EGSS) of 3.

In 52.5% of phase 2 participants using once daily IDP-126 a 2 grade or more reduction was seen in acne severity compared with 8.1% of participants using the vehicle gel. In the phase 3 studies, participants showed a 49.6% and 50.5% improvement compared with 24.9% and 20.5% in the control group. Researchers also reported reductions of inflammatory and noninflammatory lesions of more than 70% compared with 45% to 50% for the control groups.

Treatment-related adverse events were mild—the most common adverse events include site pain, dryness, and exfoliation. No serious adverse events related to treatment were reported.

“To our knowledge, acne improvements with IDP-126 were greater than any FDA-approved topical acne treatment, though patient populations may differ across studies,” the researchers concluded.

Disclosure: This research was supported by Ortho Dermatologics, a division of Bausch Health U.S. Please see the original reference for a full list of disclosures. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Stein Gold L, Baldwin H, Kircik LH, et al. Efficacy and safety of a fixed-dose clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel for moderate-to-severe acne: A randomized phase II study of the first triple-combination drug.  Presented at: the 2022 Annual Meeting; March 25-29, 2022. Abstract/Poster 32970.