Real-World Evaluation of the Episoft® AC Moisturizer With Broad-Spectrum Sunscreen in the Management of Retinoid-Induced Dermatitis: A Retrospective Observational Study.

Abstract

Background Retinoids are essential in acne management but frequently cause retinoid‑induced dermatitis (RID), characterized by erythema, dryness, burning, and barrier disruption. This study evaluated the real‑world effectiveness and tolerability of Episoft® AC (Glenmark Pharmaceuticals, Mumbai, India), a fixed-dose combination moisturizer with broad‑spectrum sunscreen, in patients experiencing RID. Methods This study was a retrospective, multicentric observational analysis of medical records of acne patients with RID, conducted across 357 dermatology clinics in India, following an independent ethics committee approval (approval no. GSER/2024/BMR-AP/133). The study included 1364 patients who had been prescribed Episoft® AC for managing RID. The mean age was 24.49 years (SD ±5.16), and both male and female participants were included. Subjective symptoms (itching, burning, stinging, tightness) and objective signs (erythema, dark spots, dryness, roughness) were assessed at baseline, Week 2, and Week 4 using a four‑point Likert severity scale. Corneometer‑based skin hydration and adverse events (AEs) were also evaluated. The primary endpoint was reduction in dermatitis symptoms; secondary endpoints were Corneometer-measured skin hydration and overall tolerability. Results A total of 1039 (76%) patients were prescribed a topical retinoid or combination, most commonly 0.1% adapalene + 2.5% benzoyl peroxide (BPO), and 294 (22%) were prescribed oral isotretinoin. Significant improvement was observed across all parameters. By Week 4, complete resolution was reported by 68.7% of patients for itching, by 88.44% for burning, by 69.9% patients for stinging, by 72.63% for tightness, and by 61.69% patients for erythema. In addition, physicians observed significant improvement in dark spots (74.42%), dryness (70.59%), and roughness (73.73%). Hydration improved by 39.91% on Corneometer assessment. AEs were considered predominantly retinoid-associated based on clinical context; definitive causality attribution was not feasible given the retrospective, single-arm, uncontrolled design. Only 1.17% reported mostly mild‑to‑moderate AEs, which were associated with retinoid use. Conclusion Episoft® AC substantially improved the tolerance of topical and systemic retinoid therapy, reducing dermatitis symptoms, enhancing skin hydration, and demonstrating excellent safety. It represents a practical adjunct to support adherence and mitigate RID in routine dermatology practice.