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 © January 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
Abstract
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.
INTRODUCTION
Tinea cruris, a pruritic, superficial fungal infection of the groin and adjacent skin, is the second most common clinical presentation of dermatophytosis. It affects the upper inner thighs and sometimes extends to the groin and pubic
area. The infection more commonly affects men than women, and proliferation of fungi is aided by warm, moist environments; diabetes; and immunosuppression.1 Tinea cruris is caused primarily by one or more of 3 pathogens: Trichophyton rubrum, Epidermophyton floccosum, and Trichophyton mentagrophytes.2 Patient factors are very important in the risk of tinea cruris infection and its recurrence and/or relapse following treatment.1
Topical treatments for tinea cruris using allylamine and azole antifungals have demonstrated effectiveness.3-8 A recent systematic review found naftifine and terbinafine to have a slightly greater cure rate compared with bifonazole, clotrimazole, and miconazole in patients with fungal infections of the skin and feet.9 However, there have been few direct comparisons of individual topical agents, making it difficult to justify the choice of one preparation over another.7,10 Prescription topical treatments include butenafine7,11,12 and naftifine,13 which require at least 2 weeks of therapy. Longer treatment periods are believed to compromise patient adherence.4 Although over-the-counter (OTC) products are available to treat tinea cruris, patients seek medical attention for this condition, especially when treatment with OTC products has failed, caused adverse events (AEs), or been followed by recurrence.14
Luliconazole cream 1% has been approved in Japan since 2005 for treatment of tinea cruris, tinea corporis, and tinea pedis. Luliconazole cream 1% is a fungicidal (ie, kills fungi) and fungistatic (ie, inhibits the growth of fungi) azole that has exhibited in vitro activity against T rubrum, E floccosum, and T mentagrophytes greater than or equal to that of other agents, including terbinafine, ketoconazole, clotrimazole, neticonazole, miconazole, and bifonazole.15-17 Preclinical studies found luliconazole
