Two randomized, double-blind, controlled trials of 2219 subjects to compare the combination clindamycin/tretinoin hydrogel with each agent alone and vehicle for the treatment of acne vulgaris

J Am Acad Dermatol. 2006 Jan;54(1):73-81. doi: 10.1016/j.jaad.2005.04.046. Epub 2005 Nov 28.


Background: The development of a hydrogel to stabilize and solubilize clindamycin and tretinoin provides a single, once-daily treatment for acne vulgaris.

Objective: Our aim was to compare the efficacy and safety of the combination of clindamycin (1%) and tretinoin (0.025%) with each agent alone and vehicle.

Methods: Two randomized, double-blind, active drug- and vehicle-controlled 12-week studies evaluated inflammatory and noninflammatory lesion counts and the Investigator's Static Global Assessment in 2219 subjects with acne vulgaris.

Results: The combination demonstrated superior efficacy to clindamycin, tretinoin, and vehicle. Combination hydrogel was significantly more effective in reducing inflammatory (P < .005), noninflammatory (P < or = .0004), and total (P < .0001) lesion counts than the other treatments and vehicle. The proportion of subjects with clear or almost clear skin on the Investigator's Static Global Assessment was greater with the combination (P < .0001).

Limitations: A majority of subjects (82.6%) had grade 2-3 acne vulgaris at baseline; therefore these overall results may not be representative of the response in the subjects (17.4%) with grade 4-5 acne.

Conclusion: The combination clindamycin/tretinoin hydrogel was well tolerated and significantly more effective than clindamycin, tretinoin, or vehicle for the treatment of acne vulgaris.

Publication types

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

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Acne Vulgaris / pathology
  • Adolescent
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Clindamycin / adverse effects
  • Clindamycin / therapeutic use*
  • Dermatitis / pathology
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hydrogel, Polyethylene Glycol Dimethacrylate / therapeutic use*
  • Male
  • Severity of Illness Index
  • Treatment Outcome
  • Tretinoin / adverse effects
  • Tretinoin / therapeutic use*


  • Anti-Bacterial Agents
  • Hydrogel, Polyethylene Glycol Dimethacrylate
  • Clindamycin
  • Tretinoin