Cutaneous Safety and Tolerability of a Fixed Combination Clindamycin (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Moderate-to-severe Acne Vulgaris.

OBJECTIVE: To investigate the cutaneous safety and tolerability of clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel in moderate-to-severe acne patients.
METHODS: A safety assessment of 498 patients with moderate-to-severe acne receiving clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel or vehicle for 12 weeks.
RESULTS: The vast majority (80-95%) of patients reported no cutaneous safety or tolerability problems throughout the study. Mean scores for both active and vehicle were all <1 (where l=mild) and reduced over the duration of the study. When scaling, erythema, itching, burning, or stinging was reported it was generally mild. Moderate or severe reactions to clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel were rare and generally seen early in treatment. There were eight reports (3.3%) of moderate erythema, four reports (1.7%) of moderate scaling, three reports (1.2%) of moderate itching, and one report of moderate burning (0.4%) at Week 4. There was one report (0.4%) of severe erythema and one report (0.4%) of severe burning (both at Week 4), with one report (0.4%) of severe stinging at Week 12. There were no substantive differences seen in cutaneous tolerability among treatment groups and younger patients tended to have milder reactions. LIMITATIONS: It is not possible to determine the contributions of the individual active ingredients.
CONCLUSION: Clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel has a favorable safety and tolerability profile with very low incidence of moderate or severe reactions.