Efficacy and Safety of Naftifine HCl Gel 2% in the Treatment of Interdigital and Moccasin Type Tinea Pedis: Pooled Results from Two Multicenter, Randomized, Double-Blind, Vehicle-Controlled Trials
August 2013 | Volume 12 | Issue 8 | Original Article | 911 | Copyright © August 2013
Linda F. Stein Gold MD,a Lawrence Charles Parish, MD,b,c Tracey Vlahovic DPM,d Leon Kircik MD,e Stefan
Plaum MD,f Alan B. Fleischer Jr MD,f Amit Verma DrPH,f Babajide Olayinka MSc,f
and Bhushan Hardas MDf on behalf of the NAFT-600 Study Group*
aHenry Ford Health System, Detroit, MI
bDepartment of Dermatology and Cutaneous Biology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA
cPaddington Testing Company, Inc. Philadelphia, PA
dTemple University School of Podiatric Medicine, Philadelphia, PA
eMount Sinai Medical Center, New York, NY
fMerz Pharmaceuticals, LLC, Greensboro, NC
*See Appendix 1: List of Investigators from the NAFT-600 Study Group
OBJECTIVE: To evaluate the efficacy and safety of two-weeks once daily application of naftifine gel 2% in the treatment of tinea pedis.
METHODS: At baseline, 1715 subjects were randomly assigned 2:1 to naftifine gel 2% (n=1144) and vehicle (n=571). Efficacy consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline and weeks 2, 4, and 6. Efficacy was analyzed in 1174 subjects (n=782, naftifine; n=392, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 6 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 1714 subjects (n=1143, naftifine; n=571, vehicle).
RESULTS: Subjects treated with naftifine gel 2% for interdigital-type tinea pedis demonstrated greater improvement from baseline for complete cure (P=0.001), mycological cure (P<0.0001), and treatment effectiveness (P<0.0001) as early as 2 weeks when compared to vehicle; however the highest response rates were seen 4-weeks post treatment (P<0.0001, for all endpoints). Statistically significant results for complete cure, mycological cure, and treatment effectiveness (P<0.0001, for all endpoints) were also seen at week 6 among subjects with moccasin-type tinea pedis. Treatment related adverse events were minimal.
CONCLUSIONS: Treatment with naftifine gel 2% applied once daily for two weeks is well-tolerated and is effective in treating both interdigital-type and moccasin-type tinea pedis. Continuous improvement is observed from the end of treatment to four-weeks after treatment cessation among key outcome measures (complete cure, mycological cure, and treatment effectiveness) as well as clinical signs and symptoms (erythema, scaling, and pruritus).
J Drugs Dermatol. 2013;12(8):911-918.