[Azelaic acid 15% gel in the treatment of acne vulgaris. Combined results of two double-blind clinical comparative studies]

J Dtsch Dermatol Ges. 2004 Oct;2(10):841-7. doi: 10.1046/j.1439-0353.2004.04731.x.
[Article in German]


Background: Topical measures are still the mainstay in the therapy of mild-to-moderate acne vulgaris. Azelaic acid 20% in a cream formulation has been established as an efficacious and safe topical drug for 15 years. A new non-alcoholic hydrogel formulation containing 15% azelaic acid was clinically tested against two standard drugs--5% benzoyl peroxide (BPO) and 1% clindamycin.

Patients and methods: In two independent, randomized, blinded comparative trials 15% azelaic acid gel was clinically tested against 5% benzoyl peroxide (BPO) gel in 351 patients and against 1% clindamycin gel in 229 patients. The drugs were applied b.i.d. for 4 months.

Results: Azelaic acid 15% gel proved to be as effective as BPO and clindamycin with median % reduction of the inflamed lesion (papules and pustules) of 70%, and 71% respectively. The azelaic acid gel was well-tolerated, the side effects (local burning and irritation) were distinctly less than with BPO but more pronounced than with clindamycin. Despite these side effects, the treatment was well-accepted by the majority of patients.

Conclusions: Azelaic acid gel is an effective topical monotherapy for mild-to-moderate acne vulgaris; its new gel form is an enrichment of acne therapy.

Publication types

  • Comparative Study
  • English Abstract
  • Randomized Controlled Trial

MeSH terms

  • Acne Vulgaris / diagnosis*
  • Acne Vulgaris / drug therapy*
  • Administration, Topical
  • Adolescent
  • Adult
  • Anti-Bacterial Agents / administration & dosage
  • Benzoyl Peroxide / administration & dosage*
  • Child
  • Clindamycin / administration & dosage*
  • Dermatologic Agents / administration & dosage*
  • Dicarboxylic Acids / administration & dosage*
  • Double-Blind Method
  • Female
  • Gels / administration & dosage
  • Humans
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Treatment Outcome


  • Anti-Bacterial Agents
  • Dermatologic Agents
  • Dicarboxylic Acids
  • Gels
  • Clindamycin
  • azelaic acid
  • Benzoyl Peroxide