OBJECTIVE: To investigate the cutaneous safety and tolerability of @entity10758 1.2%/ @entity18575 3.75% gel in moderate-to-severe @entity5477 @entity1 . METHODS: A safety assessment of 498 @entity1 with moderate-to-severe @entity5477 receiving @entity10758 1.2%/ @entity18575 3.75% gel or vehicle for 12 weeks. RESULTS: The vast majority (80-95%) of @entity1 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, @entity5105 , itching, burning, or stinging was reported it was generally mild. Moderate or severe reactions to @entity10758 1.2%/ @entity18575 3.75% gel were rare and generally seen early in treatment. There were eight reports (3.3%) of moderate @entity5105 , 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 @entity5105 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 @entity1 tended to have milder reactions. LIMITATIONS: It is not possible to determine the contributions of the individual active ingredients. CONCLUSION: @entity10758 1.2%/ @entity18575 3.75% gel has a favorable safety and tolerability profile with very low incidence of moderate or severe reactions.

Cutaneous Safety and Tolerability of a Fixed Combination Clindamycin (1.2%) and @entity18575 (3.75%) Aqueous Gel in Moderate-to-severe XXXX .

@entity10758 :: ('MESH:C007084', 'Chemical') :: ['clindamycin phosphate', 'Clindamycin phosphate'] @entity5477 :: ('MESH:D000152', 'Disease') :: ['acne'] @entity1 :: ('9606', 'Species') :: ['patients'] @entity18575 :: ('MESH:D001585', 'Chemical') :: ['benzoyl peroxide'] @entity5105 :: ('MESH:D004890', 'Disease') :: ['erythema']
@entity5477 :: (MESH:D000152,Disease) :: ['Acne Vulgaris']
