title: Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study.
abstract: BACKGROUND
  Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis.
  
  
  OBJECTIVE
  This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis.
  
  
  METHODS
  A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (i.e., days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments.
  
  
  RESULTS
  Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P< 0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle.
  
  
  CONCLUSIONS
  This study was conducted in a relatively small population under controlled clinical trial conditions.
  
  
  CONCLUSIONS
  Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.
authors.forename: Michael
authors.initials: M
authors.lastname: Jarratt
authors.forename: Terry
authors.initials: T
authors.lastname: Jones
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Adelglass
authors.forename: Alicia
authors.initials: A
authors.lastname: Bucko
authors.forename: Richard
authors.initials: R
authors.lastname: Pollak
authors.forename: Amaury
authors.initials: A
authors.lastname: Roman-Miranda
authors.forename: Jason T
authors.initials: JT
authors.lastname: Olin
authors.forename: Leonard
authors.initials: L
authors.lastname: Swinyer
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D014008:Tinea Pedis / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D007093:Imidazoles; C112528:luliconazole