Randomized tolerability analysis of clindamycin phosphate 1.2%-tretinoin 0.025% gel used with benzoyl peroxide wash 4% for acne vulgaris

Cutis. 2010 Dec;86(6):310-8.


The multiple etiologic factors involved in acne vulgaris make the use of several medications necessary to treat the condition. Use of a fixed combination of clindamycin phosphate 1.2% and tretinoin 0.025% in conjunction with a benzoyl peroxide (BPO) wash 4% targets several pathologic factors simultaneously and mitigates the potential for clindamycin-induced Propionibacterium acnes-resistant strains. New formulations may allow such regimens to be effectively used without overly reduced tolerability resulting from the irritation potential of tretinoin and BPO. This randomized, single-blind study investigated the local tolerability, irritation potential, and safety of an aqueous-based gel (clindamycin phosphate 7.2%-tretinoin 0.025% [CT gel]) when used in conjunction with a BPO wash 4% in participants with mild to moderate acne vulgaris. Participants applied the CT gel once daily in the evening for 4 weeks in conjunction with once-daily morning use of either BPO wash 4% or nonmedicated soap-free cleanser lotion (SFC). Local tolerability and irritation potential were assessed by participants and investigators using separate 6-point scales. The frequency and severity of dryness, scaling, erythema, burning/stinging, and itching increased during the first week of treatment in both treatment arms but decreased thereafter. Local tolerability reactions were slightly more frequent in the CT gel + BPO wash group versus the CT gel + SFC group at week 1 but were generally mild and improved within 1 to 2 weeks. In conclusion, therapy with CT gel + BPO wash appears safe and well-tolerated in participants with mild to moderate 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
  • Adult
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use
  • Benzoyl Peroxide / administration & dosage
  • Benzoyl Peroxide / adverse effects*
  • Benzoyl Peroxide / therapeutic use
  • Child
  • Clindamycin / administration & dosage
  • Clindamycin / adverse effects*
  • Clindamycin / therapeutic use
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / adverse effects*
  • Dermatologic Agents / therapeutic use
  • Drug Combinations
  • Drug Therapy, Combination
  • Female
  • Gels
  • Humans
  • Keratolytic Agents / administration & dosage
  • Keratolytic Agents / adverse effects
  • Keratolytic Agents / therapeutic use
  • Male
  • Severity of Illness Index
  • Single-Blind Method
  • Tretinoin / administration & dosage
  • Tretinoin / adverse effects*
  • Tretinoin / therapeutic use
  • Young Adult


  • Anti-Bacterial Agents
  • Dermatologic Agents
  • Drug Combinations
  • Gels
  • Keratolytic Agents
  • clindamycin, tretinoin drug combination
  • Clindamycin
  • Tretinoin
  • Benzoyl Peroxide