title: 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.
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.
  
  
  CONCLUSIONS
  The study was conducted under controlled conditions in a relatively small population.
  
  
  CONCLUSIONS
  Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.
authors.forename: Terry M
authors.initials: TM
authors.lastname: Jones
authors.forename: Michael T
authors.initials: MT
authors.lastname: Jarratt
authors.forename: Ines
authors.initials: I
authors.lastname: Mendez-Moguel
authors.forename: Nelly
authors.initials: N
authors.lastname: Paz
authors.forename: Steven K
authors.initials: SK
authors.lastname: Grekin
authors.forename: Christina
authors.initials: C
authors.lastname: Cognata Smith
authors.forename: Mandeep
authors.initials: M
authors.lastname: Kaur
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005658:Fungi / Q000187:drug effects; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009824:Ointments; D014005:Tinea / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D007093:Imidazoles; D009824:Ointments; C112528:luliconazole