Double-blind, randomized, vehicle-controlled clinical trial of once-daily benzoyl peroxide/clindamycin topical gel in the treatment of patients with moderate to severe rosacea.

Abstract

BACKGROUND:

Systemic antibiotics such as tetracycline are well accepted as effective in treating the inflammatory papular/pustular phase of rosacea but may be associated with systemic side-effects. Few controlled data on the use of topical antibiotics in rosacea are available.

OBJECTIVE:

We evaluated the efficacy and tolerability of a fixed combination of 5% benzoyl peroxide and 1% clindamycin in a topical gel for the treatment of rosacea. Methods This was a 12-week, double-blind, vehicle-controlled, randomized, prospective, parallel-group study in 53 patients with moderate to severe rosacea.

RESULTS:

The mean percentage reduction in papules and pustules from baseline to the end of treatment was 71.3% in the benzoyl peroxide/clindamycin group (n = 26) and 19.3% in the vehicle group (n = 26; P = 0.0056). A significant (P = 0.0141) difference in favor of benzoyl peroxide/clindamycin was evident by the third week of treatment. Severity scores for erythema, papules/pustules, and flushing/blushing decreased more with benzoyl peroxide/clindamycin than with vehicle. Overall rosacea severity, Physician Global Assessment, and Patient's Global Assessment at the end of treatment were all significantly improved with benzoyl peroxide/clindamycin compared with vehicle (P = 0.0101, 0.0026, and 0.0002, respectively). Application site reactions were reported in four patients (14.8%) in the benzoyl peroxide/clindamycin group.

CONCLUSION:

A once-daily topical application of a combination of 5% benzoyl peroxide and 1% clindamycin is effective and well tolerated in patients with moderate to severe rosacea.

• Authors: Debra Breneman, Ronald Savin, Christine VandePol, George Vamvakias, Sharon Levy, James Leyden
• Journal: International journal of dermatology (Int J Dermatol) Vol. 43 Issue 5 Pg. 381-7 (May 2004) ISSN: 0011-9059 [Print] England
• PMID: 15117375 (Publication Type: Clinical Trial, Historical Article, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Gels
• Clindamycin
• Benzoyl Peroxide

Topics

• Administration, Cutaneous
• Adolescent
• Adult
• Aged
• Anti-Bacterial Agents (administration & dosage)
• Benzoyl Peroxide (administration & dosage)
• Clindamycin (administration & dosage)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Gels
• History, 17th Century
• Humans
• Male
• Prospective Studies
• Rosacea (drug therapy, pathology)
• Severity of Illness Index
• Treatment Outcome
• United States