title: A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris.
abstract: OBJECTIVE
  Naftifine HCl 2% cream (NAFT-2%) is a topical allylamine antifungal preparation under development in the U.S. The objective of this randomized, double-blind, vehicle-controlled study was to evaluate the efficacy and safety of a two-week course of once-daily NAFT-2% vs. vehicle in the treatment of Tinea cruris ("jock itch").
  
  
  METHODS
  A total of 334 subjects with T. cruris were enrolled and randomly assigned to NAFT-2% (n=166) or vehicle (n=168), which was applied once daily for 14 days. Efficacy and safety were evaluated at week 2 (end of treatment) and week 4. Efficacy measures included complete cure, treatment effectiveness, mycological cure, clinical cure, and clinical success and were analyzed only in subjects with a positive potassium hydroxide (KOH) and dermatophyte culture at baseline (n=75, naftifine; n=71, vehicle). Safety was assessed by adverse events and changes from baseline in clinical status and laboratory studies.
  
  
  RESULTS
  At week 4, 25 percent of naftifine-treated subjects achieved complete cure vs. three percent of vehicle subjects and 72 percent achieved mycological cure vs. 16 percent of vehicle treated subjects (one-sided, P<0.001). Treatment effectiveness was achieved in 60 percent of NAFT-2% subjects vs. 10 percent of vehicle subjects (one-sided, P<0.001). Clinical cure rate and clinical success rate were 33 percent and 84 percent in NAFT-2% subjects, respectively vs. 10 percent and 46 percent in vehicle subjects (both P is less than 0.001, 2-sided). Week 2 efficacy response rates in NAFT-2% subjects were all lower than at week 4 but were significantly higher than week 2 vehicle-treated counterparts (P<0.025). Treatment-related AE occurred in 11 subjects (7 NAFT-2%, 4 vehicle) during the study. The most common AE in both groups were contact dermatitis (2 NAFT-2%), pruritus (2 vehicle), and application site reaction (1 per group).
  
  
  CONCLUSIONS
  NAFT-2% applied once daily for two weeks (one-half the treatment duration for naftifine 1% cream) is efficacious and safe for the treatment of T. cruris.
authors.affiliation: Department of Dermatology and Cutaneous Biology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA, USA. lparish@parishdermatology.com
authors.forename: Lawrence Charles
authors.initials: LC
authors.lastname: Parish
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Parish
authors.forename: Hirak B
authors.initials: HB
authors.lastname: Routh
authors.forename: Edward
authors.initials: E
authors.lastname: Avakian
authors.forename: Babajide
authors.initials: B
authors.lastname: Olayinka
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Pappert
authors.forename: Stefan
authors.initials: S
authors.lastname: Plaum
authors.forename: Alan B
authors.initials: AB
authors.lastname: Fleischer
authors.forename: Bhushan
authors.initials: B
authors.lastname: Hardas
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000499:Allylamine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D014005:Tinea / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D000499:Allylamine; C029178:naftifine