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Outline
What is the generic name?
CLINDAMYCIN
What is the Trade Name for CLINDAMYCIN?
Clindagel
What are the Indications for CLINDAMYCIN?
- 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 treatment 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% P<0.05 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.
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References: https://open.fda.gov/
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