A combined analysis of 2 randomized clinical studies of tretinoin gel 0.05% for the treatment of acne

Cutis. 2009 Mar;83(3):146-54.


Acne vulgaris is a widely prevalent skin disorder primarily treated with retinoids, which have been shown to cause skin irritation. This report describes the combined analysis of 2 similar phase 3 studies designed to evaluate the efficacy and safety of an aqueous gel formulation of tretinoin relative to its vehicle (both studies) and a marketed microsphere formulation of tretinoin (one study) for once-daily topical treatment of acne. Randomized participants 10 years and older with mild to moderate acne (N=1537) received tretinoin gel 0.05% (n=674), tretinoin gel microsphere 0.1% (n=376), or vehicle (n=487) once daily for 12 weeks. Tretinoin gel was more effective than vehicle in reducing inflammatory (P<.001) and noninflammatory (P<.001) lesion counts over 12 weeks. Treatment success rate (global severity score, 0 or 1) was significantly greater in the tretinoin gel 0.05% group compared with the vehicle group (P<.001). The efficacy rate of tretinoin gel 0.05% was approximately 12% less than tretinoin gel microsphere 0.1%. Adverse events (AEs) were generally mild to moderate and rarely resulted in participant discontinuation. Incidence of skin-related AEs in the tretinoin gel 0.05% group (31%) was significantly lower compared with the tretinoin gel microsphere 0.1% group (52%)(P<.001). Thus, tretinoin gel 0.05% applied once daily is a well-tolerated and effective therapy for acne vulgaris and is associated with a low incidence of skin-related AEs.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Administration, Topical
  • Adolescent
  • Adult
  • Aged
  • Child
  • Clinical Trials, Phase III as Topic
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / therapeutic use*
  • Female
  • Gels
  • Humans
  • Male
  • Microspheres
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • Tretinoin / administration & dosage
  • Tretinoin / therapeutic use*


  • Dermatologic Agents
  • Gels
  • Tretinoin