title: 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.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Venerology and Dermatology, Otto-von-Guericke University, Magdeburg, Germany.
authors.forename: H P M
authors.initials: HP
authors.lastname: Gollnick
authors.affiliation: Dermatologist in Private Practice, Oranienburg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Friedrich
authors.affiliation: Dermatologist in Private Practice, Freiburg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Peschen
authors.affiliation: Dermatologist in Private Practice, Berlin, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Pettker
authors.affiliation: Dermatologist in Private Practice, Lippstadt, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Pier
authors.affiliation: Dermatologist in Private Practice, Buchholz in der Nordheide, Germany.
authors.forename: V
authors.initials: V
authors.lastname: Streit
authors.affiliation: Med:Unit GmbH, Köln, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Jöstingmeyer
authors.affiliation: Galderma Laboratorium GmbH, Düsseldorf, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Porombka
authors.affiliation: Galderma Laboratorium GmbH, Düsseldorf, Germany.
authors.forename: I
authors.initials: I
authors.lastname: Rojo Pulido
authors.affiliation: Galderma Laboratorium GmbH, Düsseldorf, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Jäckel
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene / Q000009:adverse effects / Q000627:therapeutic use*; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001585:Benzoyl Peroxide / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D017453:Dermatitis, Irritant / Q000209:etiology; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D004890:Erythema / Q000139:chemically induced; D005148:Facial Dermatoses / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D000068816:Adapalene; D001585:Benzoyl Peroxide