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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(s) -
Gollnick H.P.M.,
Friedrich M.,
Peschen M.,
Pettker R.,
Pier A.,
Streit V.,
Jöstingmeyer P.,
Porombka D.,
Rojo Pulido I.,
Jäckel A.
Publication year - 2015
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.13194
Subject(s) - adapalene , medicine , acne , benzoyl peroxide , concomitant , dermatology , tolerability , clinical endpoint , adverse effect , randomized controlled trial , chemistry , organic chemistry , polymer , polymerization
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.