Clinical safety and efficacy studies of a novel formulation combining 1.2% clindamycin phosphate and 0.025% tretinoin for the treatment of acne vulgaris.
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.
Schlessinger
Joel
J
Advanced Skin Research Center, Omaha, NE, USA.
Menter
Alan
A
Gold
Michael
M
Leonardi
Craig
C
Eichenfield
Lawrence
L
Plott
R Todd
RT
Leyden
James
J
Wortzman
Mitchell
M
D000152:Acne Vulgaris / Q000188:drug therapy*; D002981:Clindamycin / Q000009:adverse effects / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D004338:Drug Combinations; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014212:Tretinoin / Q000009:adverse effects / Q000627:therapeutic use*
D004338:Drug Combinations; C117880:clindamycin, tretinoin drug combination; D002981:Clindamycin; D014212:Tretinoin