CLINICAL STUDIES
In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used
Clindagel
®
(clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatement of acne vulgaris of mild to moderate severity,
Clindagel®
applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table:
Lesions |
Clindagel® QD
N=162
|
Vehicle Gel
QD
N=82
|
Inflammatory |
51% |
40%
|
Noninflammatory |
25% |
12% |
Total |
38% |
27% |
There was a trend in the investigator's global assessment of the results which favored
Clindagel®
QD over the vehicle QD.
In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to
Clindagel®.
There was no signal for contact sensitization in the clinical trials under normal use conditions.
INDICATIONS AND USAGE
Clindagel®
is indicated for topical application in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS.)
|