March 26, 2022
1 min read
Stein Gold L, et al. Poster. 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: Randomized phase 2 and phase 3 studies of the first triple-combination drug. Presented at: American Academy of Dermatology Annual Meeting; March 25-29, 2022; Boston.
Stein Gold reports serving as an investigator, consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, Pfizer, Sun Pharma, UCB, Arcutis and Lilly. Please see the study for all other authors’ relevant financial disclosures.
BOSTON — A fixed-dose triple combination topical gel formulation of clindamycin phosphate, benzoyl peroxide and adapalene reduced more than 70% of acne lesions in phase 2 and 3 trials, according to a poster presentation.
“A three-pronged approach to acne treatment — combining an antibiotic, antibacterial and retinoid — may provide greater efficacy and tolerability than single/double treatments while potentially reducing antibiotic resistance and increasing compliance,” Linda Stein Gold, MD, of Henry Ford Hospital in Detroit, Michigan, and colleagues wrote.
Results from a phase 2 trial and two phase 3 trials of IDP-126 (fixed dose clindamycin phosphate 1.2%, benzoyl peroxide 3.1% and adapalene 0.15%, Ortho Dermatologics) were detailed in the poster presented at the American Academy of Dermatology Annual Meeting.
Linda Stein Gold
Of those treated with IDP-126, 52.5% in the phase 2 trial and 49.6% and 50.5% in the respective phase 3 trials achieved treatment success, defined as an improvement of at least two grades in the Evaluator’s Global Severity Score and clear or almost clear skin at 12 weeks. This compared with 8.1%, 24.9% and 20.5% of those treated with vehicle.
Reduction of inflammatory and noninflammatory lesions was greater than 70% in the treatment groups as well.
“The innovative fixed-dose, triple combination IDP-126 gel was efficacious and well tolerated in three clinical studies including children, adolescents and adults with moderate to severe acne,” the authors wrote. “To our knowledge, acne improvement with IDP-126 was greater than any FDA approved topical acne treatment, though patient populations may differ across studies.”