A Randomized, Multicenter, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Luliconazole Cream 1% Once Daily for 7 Days in Patients Aged ≥ 12 Years With Tinea Cruris
January 2014 | Volume 13 | Issue 1 | Original Article | 32 | Copyright © 2014
Terry M. Jones MD,a Michael T. Jarratt MD,b Ines Mendez-Moguel MD,c Nelly Paz MD,d Steven K. Grekin DO,e
Christina Cognata Smith PharmD MBA,f and Mandeep Kaur MD MSf
aJ&S Studies, Inc., College Station, TX
bDermResearch, Austin, TX
cFXM Research International, Belize City, Belize
dHospital y Bendana, San Pedro Sula, Honduras
eGrekin Skin Institute, Warren, MI
fFormerly of Medicis, a division of Valeant Pharmaceuticals, Scottsdale, AZ
BACKGROUND: Tinea cruris, a pruritic superficial fungal infection of the groin, is the second most common clinical presentation for dermatophytosis.
OBJECTIVE: This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris.
METHODS: 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days. Efficacy was evaluated at baseline and at days 7, 14, 21, and 28 based on mycology (potassium hydroxide, fungal culture) and clinical signs (erythema, scaling, pruritus). The primary outcome was complete clearance at day 28 (21 days posttreatment). Safety evaluations included adverse events and laboratory assessments.
RESULTS: Complete clearance was obtained in 21.2% (35/165) of patients treated with luliconazole cream 1% compared with 4.4% (4/91) treated with vehicle (P<0.001). The safety profile of luliconazole cream 1% was similar to vehicle.
LIMITATIONS: The study was conducted under controlled conditions in a relatively small population.
CONCLUSION: Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.
J Drugs Dermatol. 2014;13(1):32-38.
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