| Title | Clinical safety and efficacy studies of a novel formulation combining 1.2% clindamycin phosphate and 0.025% tretinoin for the treatment of acne vulgaris. | | Author(s) | Schlessinger J, Menter A, Gold M, Leonardi C, Eichenfield L, Plott RT, Leyden J, Wortzman M, ZIANA Study Group | | Institution | Advanced Skin Research Center, Omaha, NE, USA. | | Source | J Drugs Dermatol 2007 Jun; 6(6):607-15. | | Abstract | Clindamycin phosphate 1.2% and tretinoin 0.025% gel (CLIN/RA gel [ZIANA Gel]) is a novel topical combination agent approved by the FDA for the treatment of acne vulgaris in patients 12 years of age or older. A solution of clindamycin phosphate 1.2% combined with partially solubilized and crystalline tretinoin 0.025% suspended in an aqueous-based, alcohol-free gel formulation, CLIN/RA gel was studied in 2 randomized, vehicle-controlled trials involving more than 4,500 patients. Efficacy results from these studies showed that treatment with the combination significantly reduced lesion counts and improved patients' overall appearance to a greater extent than the individual components. Individual ingredients and the combination were well-tolerated. Among those treated with the combination formulation, discontinuation rates due to adverse events were 1% or less. | | Language | eng | | Pub Type(s) | Journal Article
| | PubMed ID | 17668526 |
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