title: When do efficacy outcomes in clinical trials correlate with clinical relevance? analysis of clindamycin phosphate 1.2%-benzoyl peroxide 3.75% gel in moderate to severe acne vulgaris.
abstract: Acne vulgaris (AV) is a common skin disease that is challenging to successfully treat due to its complex underlying pathophysiology and chronicity. Unrealistic expectations based on the desire for rapid and complete clearance or local tolerability reactions related to topical medications often lead to incomplete adherence with therapy, premature treatment cessation, and poor therapeutic outcomes. Despite stressing to patients the importance of compliance and the lag time of several weeks before visible improvement may be noted with treatments for AV, data on evaluation of the time taken to achieve a clinically meaningful improvement of AV that may be perceived by clinicians and patients are limited. Clindamycin phosphate 1.2%-benzoyl peroxide 3.75% (clindamycin-BP 3.75%) gel has been shown in pivotal trials to be effective and well tolerated in patients with moderate to severe AV. This article reviews a new concept referred to as time to onset of action (TOA), which is described in detail and illustrated using the pivotal trial data with clindamycin-BP 3.75% gel for treatment of AV.
authors.affiliation: Lakes Dermatology and Del Rosso Dermatology Research Center, Las Vegas, Nevada, USA.
authors.forename: James Q
authors.initials: JQ
authors.lastname: Del Rosso
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology; D001585:Benzoyl Peroxide / Q000494:pharmacology*; D002908:Chronic Disease; D002981:Clindamycin / Q000031:analogs & derivatives* / Q000494:pharmacology; D002986:Clinical Trials as Topic; D003879:Dermatologic Agents / Q000494:pharmacology; D006801:Humans; D010349:Patient Compliance / Q000523:psychology*; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D002981:Clindamycin; C007084:clindamycin phosphate; D001585:Benzoyl Peroxide