Clinical efficacy and safety comparison of adapalene gel and tretinoin gel in the treatment of acne vulgaris: Europe and U.S. multicenter trials

J Am Acad Dermatol. 1997 Jun;36(6 Pt 2):S126-34. doi: 10.1016/s0190-9622(97)70056-2.

Abstract

Background: Adapalene is a new chemical entity that exhibits tretinoin-like activities in the terminal differentiation process.

Objective: We evaluated a dose range effect of two concentrations of adapalene gel as acne treatment and compared adapalene 0.1% gel with tretinoin 0.025% gel in the treatment of acne patients in two large multicenter studies.

Methods: Multicenter, investigator-masked, parallel group studies including 89 acne patients in the dose range study and 591 patients in the concurrent controlled studies were conducted.

Results: Adapalene gel 0.1% was significantly more effective in treating acne lesions than 0.03% adapalene gel. Adapalene gel 0.1% was significantly more effective than 0.025% or tretinoin gel in one study and of the same effectiveness in the other study. Adapalene gel was always better tolerated than tretinoin gel.

Conclusion: Adapalene 0.1% gel is a safe and effective treatment of acne vulgaris.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adapalene
  • Administration, Topical
  • Adolescent
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Child
  • Dose-Response Relationship, Drug
  • Europe
  • Female
  • Gels
  • Humans
  • Keratolytic Agents / administration & dosage
  • Keratolytic Agents / therapeutic use*
  • Male
  • Naphthalenes / administration & dosage
  • Naphthalenes / therapeutic use*
  • Treatment Outcome
  • Tretinoin / administration & dosage
  • Tretinoin / therapeutic use*
  • United States

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Gels
  • Keratolytic Agents
  • Naphthalenes
  • Adapalene
  • Tretinoin