Clinical safety and efficacy studies of a novel formulation combining 1.2% clindamycin phosphate and 0.025% tretinoin for the treatment of acne vulgaris

J Drugs Dermatol. 2007 Jun;6(6):607-15.

Abstract

Clindamycin phosphate 1.2% and tretinoin 0.025% gel (CLIN/RA gel [ZIANA Gel]) is a novel topical combination agent approved by the FDA for the treatment of acne vulgaris in patients 12 years of age or older. A solution of clindamycin phosphate 1.2% combined with partially solubilized and crystalline tretinoin 0.025% suspended in an aqueous-based, alcohol-free gel formulation, CLIN/RA gel was studied in 2 randomized, vehicle-controlled trials involving more than 4,500 patients. Efficacy results from these studies showed that treatment with the combination significantly reduced lesion counts and improved patients' overall appearance to a greater extent than the individual components. Individual ingredients and the combination were well-tolerated. Among those treated with the combination formulation, discontinuation rates due to adverse events were 1% or less.

Publication types

  • Meta-Analysis
  • Review

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Clindamycin / adverse effects
  • Clindamycin / therapeutic use*
  • Clinical Trials, Phase III as Topic
  • Drug Combinations
  • Humans
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • Tretinoin / adverse effects
  • Tretinoin / therapeutic use*

Substances

  • Drug Combinations
  • clindamycin, tretinoin drug combination
  • Clindamycin
  • Tretinoin