Efficacy and safety of topical azelaic acid (20 percent cream): an overview of results from European clinical trials and experimental reports

Cutis. 1996 Jan;57(1 Suppl):20-35.


Azelaic acid cream (20 percent) is a new topical treatment for acne with an additional therapeutic potential in rosacea and hyperpigmentation disorders. Azelaic acid (AzA; HOOC-(CH2)7-COOH) is a naturally occurring compound that interferes with acne pathogenesis by virtue of its antikeratinizing, antibacterial, and anti-inflammatory properties. Vehicle-controlled studies have verified that AzA exercises a significant and clinically relevant effect on both non-inflammatory and inflammatory acne lesions. Comparisons with clinically proven therapies have shown that 20 percent AzA cream is an effective monotherapy in mild to moderate forms of acne, with an overall efficacy comparable to that of tretinoin (0.05 percent), benzoyl peroxide (5 percent), and topical erythromycin (2 percent). In the treatment of moderate to severe acne, 20 percent AzA cream may be favorably combined with minocycline (90 percent good and excellent results), and may contribute towards reducing recurrences following discontinuation of systemic therapy (maintenance therapy with AzA cream). Particular advantages of AzA therapy include its favorable safety and side effect profile. It is non-teratogenic, is not associated with systemic adverse events or photodynamic reactions, exhibits excellent local tolerability, and does not induce resistance in Propionibacterium acnes.

Publication types

  • Review

MeSH terms

  • Acne Vulgaris / drug therapy
  • Administration, Topical
  • Clinical Trials as Topic
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Dicarboxylic Acids / administration & dosage*
  • Dicarboxylic Acids / adverse effects
  • Drug Tolerance
  • Humans
  • Ointments
  • Rosacea / drug therapy
  • Safety
  • Treatment Outcome


  • Dermatologic Agents
  • Dicarboxylic Acids
  • Ointments
  • azelaic acid