1. Safety and efficacy of adapalene 0.1% / benzoyl peroxide 2.5% in the long-term treatment of predominantly moderate acne with or without concomitant medication - results from the non-interventional cohort study ELANG.
- Author
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Gollnick HP, Friedrich M, Peschen M, Pettker R, Pier A, Streit V, Jöstingmeyer P, Porombka D, Rojo Pulido I, and Jäckel A
- Subjects
- Adapalene adverse effects, Administration, Cutaneous, Adolescent, Adult, Aged, Anti-Bacterial Agents therapeutic use, Benzoyl Peroxide adverse effects, Child, Dermatitis, Irritant etiology, Drug Combinations, Drug Therapy, Combination, Erythema chemically induced, Female, Humans, Male, Middle Aged, Prospective Studies, Severity of Illness Index, Time Factors, Young Adult, Acne Vulgaris drug therapy, Adapalene therapeutic use, Benzoyl Peroxide therapeutic use, Facial Dermatoses drug therapy
- Abstract
Background: Acne is a chronic inflammatory disease requiring long-term treatment. The fixed-dose combination adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO) is indicated for the once-daily topical treatment of Acne vulgaris when comedones, papules and pustules are present., Objective: The main objectives of this non-interventional study were to assess long-term efficacy and safety of adapalene-BPO in moderate to severe acne with and without concomitant medication., Methods: Patients with moderate to severe acne received adapalene-BPO alone or in combination with concomitant medication over a course of 9 months. The primary efficacy endpoint was changes in acne severity according to the Leeds Revised Acne Grading System; secondary endpoints included treatment success assessed by the patient and safety., Results: In total, 5131 patients were eligible for efficacy and 5141 for safety evaluation. The majority of patients (78.8%) received adapalene-BPO alone. About 21.2% received adapalene-BPO in combination with another agent, mostly topical antibiotics (8.8%) or systemic antibiotics (8.7%). Mean (±SD) acne severity improved from 5.6 ± 1.5 at baseline to 3.3 ± 1.9 at month 3, and further to 1.9 ± 1.9 at month 9 (both P < 0.0001). The degree of improvement correlated significantly with the severity at baseline. After 3 and 9 months of treatment, the facial skin was cleared completely (no more visible acne lesions) in 420 (8.2%) and 1326 patients (25.8%), respectively. A therapeutic effect was noted by the patients after a median time of 3 weeks (range: from 1 day to 12 weeks). No serious adverse events were reported. Facial skin irritations, mostly mild to moderate, occurred in 49.5% of patients and led to discontinuation in only 1.7% of cases., Conclusion: In consistence with previous clinical findings, the use of adapalene-BPO in daily practice routine is safe and effective in the long-term management of patients with moderate to severe acne., (© 2015 European Academy of Dermatology and Venereology.)
- Published
- 2015
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