Dermal Irritation, Sensitization, and Safety of Fixed-Dose Triple-Combination Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.1%/Adapalene 0.15% Gel in Healthy Participants

Introduction: IDP-126 polymeric mesh gel (clindamycin phosphate 1.2%/benzoyl peroxide [BPO] 3.1%/adapalene 0.15%) is the first triple-combination, fixed-dose topical acne product in development and it addresses major pathophysiological processes. demonstrated superior efficacy to vehicle component dyads, with good safety/tolerability a phase 2 study of participants moderate-to-severe acne. The objectives this were assess dermal irritation/sensitization safety two 1 studies compare irritancy commercially available BPO 2.5%/adapalene 0.3% one healthy participants.
 Methods: Two 1, randomized, evaluator-blinded, within-participant, enrolled aged ≥18 years (N=234, repeat insult patch test [RIPT]; N=45, cumulative irritation [CIPT]). Patches applied upper back multiple times over 6-8 weeks (RIPT) or every 24 hours for 21 days (CIPT). contained: gel, saline 0.9% (RIPT/CIPT), sodium lauryl sulfate (SLS) 0.5% (CIPT), branded Participants each received all treatments. Endpoints comprised sensitization potential (RIPT), mean cumulative/total scores, treatment-emergent adverse events (TEAEs).
 Results: Overall, was moderate not clinically significant. CIPT: “moderately irritating” (mean score: 1.29), which significantly less irritating than BPO/adapalene (1.96; P<0.001), statistically similar SLS (1.17), more (~0.30; P<0.001). RIPT: no had investigator-confirmed any In both studies, TEAEs related treatment.
 Conclusions: fixed-dose, triple-combination clindamycin 1.2%/ 0.15% confirmed participants. Additionally, versus available, gel. safety/tolerability, mirroring results.
 
 Funding: Ortho Dermatologics