An observer-blind parallel-group, randomized, multicentre clinical and microbiological study of a topical clindamycin/zinc gel and a topical clindamycin lotion in patients with mild/moderate acne

J Dermatolog Treat. 2005;16(4):213-8. doi: 10.1080/09546630500281957.

Abstract

Introduction: A topical acne treatment in which clindamycin phosphate equivalent to 1% clindamycin is presented in a gel formulation has received marketing authorizations in a number of EU and non-EU countries. Clindamycin/zinc gel contains zinc acetate in a formulation that reduces systemic absorption of clindamycin through the skin.

Objectives: To compare the efficacy and safety of a 1% clindamycin/zinc gel when applied to the face once daily or twice daily with a 1% clindamycin lotion applied twice daily for 16 weeks in patients with mild to moderate acne vulgaris.

Methods: This was a randomized, comparative, observer-blind, parallel-group, multicentre study involving 246 acne patients.

Results: The study demonstrated therapeutic similarity between clindamycin/zinc gel applied once and twice daily with clindamycin lotion applied twice daily. All three regimens produced a gradual and time-dependent reduction in inflamed lesions, non-inflamed lesions and overall grade. Side effects were similar and minimal, consisting predominantly of mild irritant dermatitis. All regimes produced a time-related significant reduction in skin surface and follicular Propionibacterium spp. and Micrococcaceae. The emergence of resistant strains was less than 5% and was similar with all three regimes.

Conclusion: The equivalent efficacy and safety of clindamycin/zinc gel either once or twice daily to clindamycin lotion twice daily has been demonstrated. It is suggested that a treatment regime of one application per day may significantly enhance compliance and thus treatment success in acne patients.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Acne Vulgaris / microbiology
  • Administration, Topical
  • Adolescent
  • Adult
  • Child
  • Clindamycin / administration & dosage*
  • Drug Administration Schedule
  • Drug Combinations
  • Female
  • Gels
  • Humans
  • Male
  • Propionibacterium / isolation & purification
  • Single-Blind Method
  • Skin / microbiology
  • Zinc Acetate / administration & dosage*

Substances

  • Drug Combinations
  • Gels
  • Clindamycin
  • Zinc Acetate