43390 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
Recommended Citation
Gooderham M, Simpson E, Geng B, Stein Gold LF, Wollenberg A, Farooqui SA, Zhang F, Feeney C. 43390 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. J Am Acad Dermatol 2023; 89(3):AB33.
Document Type
Conference Proceeding
Publication Date
9-19-2023
Publication Title
J Am Acad Dermatol
Abstract
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 addresses major acne pathophysiological processes. IDP-126 demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability in a phase 2 study of patients with moderate-to-severe acne [1]. Two phase 1, randomized, evaluator-blinded, within-participant, dermal safety studies enrolled healthy participants aged ≥18 years (N=234, repeat insult patch test [RIPT]; N=45, cumulative irritation patch test [CIPT]). Patches were applied to the upper back multiple times over 6-8 weeks (RIPT) or every 24 hours for 21 days (CIPT). Patches contained: IDP-126 gel, vehicle gel, saline 0.9% (RIPT/CIPT), sodium lauryl sulfate (SLS) 0.5% (CIPT), or branded BPO 2.5%/adapalene 0.3% gel (CIPT). Participants in each study received all treatments. Endpoints comprised sensitization potential (RIPT), mean cumulative/total irritation scores, and treatment-emergent adverse events (TEAEs). Overall, irritation with IDP-126 was moderate and not clinically significant. CIPT: IDP-126 was “moderately irritating” (mean score: 1.29), which was significantly less irritating than BPO/adapalene (1.96; P<0.001), statistically similar to SLS (1.17), and more irritating than saline or vehicle (∼0.30; P<0.001). RIPT: no participants had investigator- confirmed sensitization to any treatments. In both studies, no TEAEs were related to treatment. In two phase 1 studies, fixed-dose, triple-combination clindamycin phosphate 1.2%/ BPO 3.1%/adapalene 0.15% polymeric mesh gel had moderate irritancy and no confirmed sensitization in healthy participants. Additionally, IDP-126 demonstrated significantly less irritation versus commercially available, branded BPO 2.5%/adapalene 0.3% gel. IDP-126 demonstrated good safety/tolerability, mirroring the phase 2 study results.
Volume
89
Issue
3
First Page
AB33
