Efficacy and safety of adapalene gel 0.1% and 0.3% and tretinoin gel 0.05% for acne vulgaris: results of a single-center, randomized, double-blinded, placebo-controlled clinical trial on Mexican patients (skin type III-IV)

J Cosmet Dermatol. 2013 Jun;12(2):103-7. doi: 10.1111/jocd.12031.

Abstract

Background: The efficacy of topical retinoids is well known according to several clinical studies conducted predominantly among Caucasian patients. This study aimed to evaluate the efficacy and safety profile of adapalene and tretinoin among Mexican patients.

Aims: To compare adapalene 0.1 and 0.3% and tretinoin 0.05% in Mexican subjects with acne vulgaris.

Methods: We enrolled 171 patients in this single-center, randomized, double-blinded, placebo-controlled clinical trial. The patients applied on the face either adapalene 0.1%, adapalene 0.3%, tretinoin 0.05%, or placebo for 90 days and were evaluated for the reduction in total lesion counts and for the level of irritation.

Results: Tretinoin 0.05% and adapalene 0.3% were more effective than adapalene 0.1% and placebo in the reduction of both inflammatory and noninflammatory lesions. Most of adverse events to adapalene and many on tretinoin group were related to skin irritation, dry skin, scaling, pruritus, burning, and postinflammatory hyperpigmentation.

Conclusion: Adapalene 0.3% and tretinoin 0.05% are comparable in efficacy, and adapalene 0.1% offers a better safety profile in Mexican patients.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Adapalene
  • Adolescent
  • Adult
  • Child
  • Dermatitis, Irritant / etiology
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Gels
  • Humans
  • Hyperpigmentation / chemically induced
  • Keratolytic Agents / adverse effects
  • Keratolytic Agents / therapeutic use*
  • Male
  • Mexico
  • Naphthalenes / adverse effects
  • Naphthalenes / therapeutic use*
  • Pruritus / chemically induced
  • Tretinoin / adverse effects
  • Tretinoin / therapeutic use*
  • Young Adult

Substances

  • Dermatologic Agents
  • Gels
  • Keratolytic Agents
  • Naphthalenes
  • Adapalene
  • Tretinoin