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.


CONCLUSIONS
It is not possible to determine the contributions of the individual active ingredients.


CONCLUSIONS
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.
Department of Dermatology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.
Guy
G
Webster