Galderma India Pvt Ltd.

Background Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit associated with an increase in sebum secretion. Topical treatment with adapalene and benzoyl peroxide (BPO) is considered effective when used either as monotherapy or in fixed-dose combinations. However, the combination gel of 0.3% adapalene with 2.5% benzoyl peroxide (A0.3%+BPO2.5%) has not been evaluated in Indian patients with acne. This study aimed to evaluate the safety and efficacy of A0.3%+BPO2.5% gel in Indian patients with moderate-to-severe acne vulgaris. Methodology This was a 12-week prospective, multicenter, open-label, phase IV study conducted at six centers in India. Safety was assessed based on local tolerability (stinging or burning, erythema, dryness, and scaling) and any reported adverse events. Efficacy was evaluated based on reductions in the number of inflammatory and noninflammatory lesions, the Investigator's Global Assessment (IGA) scale, and the Global Assessment of Improvement (GAI) score. The patient-reported outcome was measured using the Subject Satisfaction Questionnaire. Results Of the 135 patients, 132 completed the study between December 24, 2021, and July 18, 2022 (93.9% had moderate acne; 6.1% had severe acne at baseline). The A0.3%+BPO2.5% gel was well tolerated. The reductions in the severity scores of erythema, scaling, and dryness from baseline to week 12 were 38.9%, 47.4%, and 76.5%, respectively. A targeted reduction of ≥50% in the number of inflammatory and noninflammatory lesions was achieved in 115 (87.1%) and 109 (82.6%) patients, respectively. Based on the investigator's responses to the IGA questionnaire at week 12, 28% and 40.9% of patients had clear and almost clear skin, respectively. Using the GAI scale, investigators reported that at 12 weeks from baseline, most patients presented with improvements in symptoms, such as erythema, scaling, and dryness, and none reported any worsening. Treatment satisfaction was rated as 91% by the patients. Conclusions The A0.3%+BPO2.5% gel effectively reduced the inflammatory and noninflammatory lesions and was found to be safe and well tolerated in Indians with moderate‑to‑severe acne vulgaris.

Acne vulgaris, a prevalent inflammatory skin condition, significantly impacts individuals worldwide, particularly adolescents and adults. Its chronic nature, associated sequelae, and psychosocial impact underscore the substantial burden it poses. Current treatment guidelines primarily address facial acne, with limited guidance on managing truncal acne. Personalized approaches are increasingly recognized as essential for tailoring treatments to individual patient needs. This review integrates insights from an Indian Dermatology Experts' Meeting, featuring perspectives from nine leading dermatologists. Discussions centered on analyzing acne's burden, its effects on quality of life (QoL), unmet needs in management, trifarotene's role in Indian therapy, anticipated challenges, and the importance of ancillary care. The experts highlighted acne's profound impact on patients' QoL and identified gaps in current management guidelines, especially concerning truncal acne. Trifarotene, a fourth-generation topical retinoid approved by the FDA and Drug Controller General of India (DCGI) for facial and truncal acne, demonstrated safety and efficacy across age groups. This synthesis of expert perspectives underscores the need for personalized acne management. Trifarotene emerges as a promising therapeutic option but challenges remain, particularly in optimizing ancillary care to minimize treatment-related adverse effects. Addressing these issues will enhance treatment outcomes and patient satisfaction in acne management, emphasizing the importance of tailored approaches in clinical practice.

Adapalene is a novel retinoid indicated for the topical treatment of acne vulgaris. The drug was introduced in India in 2001.

A post-marketing surveillance study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as monotherapy or in combination with other anti-acne agents in Indian patients of acne vulgaris.

A 12-week, multicentre, open-label, non-comparative study involving 571 patients from 21 centers across India was conducted between January and September of 2002. Concomitant prescription of other anti-acne drugs was permitted, if needed.

Of the 571 patients, 441 completed the treatment as per protocol. At the end of therapy, 96.3% of patients showed an improvement in their acne from baseline, with greater than 75% improvement seen in two-thirds of patients. Adverse events were reported in 24% of the patients, none of which were serious. The tolerability of therapy was rated as excellent/good in 81% of patients by physicians and in 78% by the patients.

Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients. It may be safely combined with other topical and oral anti-acne agents.