Clinically Meaningful Improvement on the Acne Quality of Life Following Treatment with IDP-126 Gel for Moderate-to-Severe Acne: A Post Hoc Exploratory Pooled Analysis of Phase III Trial Data

Acne is the most common skin condition affecting up to 25 million Americans annually and has been shown to negatively impact patient’s quality of life (QoL).[1] The Acne Quality of Life Questionnaire (Acne-QoL) was included as an exploratory endpoint in two multicenter, randomized, double-blind, vehicle-controlled Phase III studies of patients (≥9 years) with moderate-to-severe acne receiving IDP- 126 Gel or vehicle. A post hoc exploratory analysis was conducted using pooled data (N=309) from both Phase III studies to assess whether changes from baseline to week 12 in Acne-QoL domain scores (self- perception; role-emotional; role-social; acne symptoms) significantly differ between IDP-126 Gel and vehicle and whether these differences were clinically meaningful to patients, based on responder thresholds defined by McLeod et al.[2]. Acne-QoL domain scores significantly (all p < 0.001) improved for patients treated with IDP-126 Gel vs. vehicle in all four domains: role-emotional (mean difference: 4.1), self-perception (mean difference: 3.8), acne symptoms (mean difference: 2.6) and role-social (mean difference: 2.0). The proportion of responders was significantly higher (all p < 0.05) in the IDP-126 Gel group vs. vehicle for all Acne-QoL domains—self-perception (Odds Ratio [OR]:4.32, 95% Confidence Interval [CI]: 2.16-8.65), acne symptoms (OR:3.90, 95% CI: 2.11-7.23), role-social (OR:3.59, 95% CI: 1.73- 7.47) and role-emotional (OR:2.50, 95% CI: 1.36-4.58). Overall, in this post hoc exploratory analysis of pooled data from two Phase III studies, participants with moderate-to-severe acne reported statistically significant and clinically meaningful improvements in all four Acne-QoL domains after 12 weeks of treatment with IDP-126 Gel.