Tretinoin cream 0.02% for the treatment of photodamaged facial skin: a review of 2 double-blind clinical studies

Cutis. 2001 Aug;68(2):135-42.


In extensive clinical studies and practical use since its US Food and Drug Administration approval in 1995, tretinoin emollient cream 0.05% has been shown to be safe and effective in the treatment of fine facial wrinkles, mottled hyperpigmentation, and skin roughness. To provide additional prescribing flexibility for various patient needs, a new lower concentration formulation, tretinoin cream 0.02% was chosen for further development. Two multicenter, randomized, double-blind, vehicle-controlled clinical., studies were conducted to evaluate the safety and efficacy of the lower concentration tretinoin formulation in the treatment of moderate-to-severe facial photodamage. Results indicate statistically significant improvement in fine wrinkling, coarse wrinkling, and yellowing with the use of tretinoin cream 0.02% at week-24 end point, compared with placebo. Therapy with tretinoin cream 0.02% was well tolerated overall and demonstrated a favorable safety profile. Both studies demonstrated that tretinoin cream 0.02% is safe and effective for the treatment of moderate-to-severe photodamaged facial skin.

Publication types

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

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Emollients / administration & dosage
  • Esthetics
  • Facial Dermatoses / drug therapy*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Reference Values
  • Severity of Illness Index
  • Skin Aging / drug effects*
  • Treatment Outcome
  • Tretinoin / administration & dosage*


  • Emollients
  • Tretinoin