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.

Abstract

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.

• Authors: James J Leyden, Lincoln Krochmal, Alex Yaroshinsky
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 54 Issue 1 Pg. 73-81 (Jan 2006) ISSN: 1097-6787 [Electronic] United States
• PMID: 16384759 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• Acne Vulgaris (drug therapy, pathology)
• Adolescent
• Anti-Bacterial Agents (adverse effects, therapeutic use)
• Clindamycin (adverse effects, 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, therapeutic use)