The Efficacy and Safety of Efinaconazole 10% Solution for Treatment of Mild to Moderate Onychomycosis: A Pooled Analysis of Two Phase 3 Randomized Trials
July 2014 | Volume 13 | Issue 7 | Original Article | 815 | Copyright © July 2014
Aditya K. Gupta MD PhD FRCPC,a,b Boni E. Elewski MD,c Jeffrey L. Sugarman MD PhD,d
Chikara Ieda,e Hideki Kawabata MS,e Robert Kang PhD,f Radhakrishnan Pillai PhD,g
Jason T. Olin PhD,f and Shinichi Watanabe MD PhDh
aDepartment of Medicine, University of Toronto, Toronto, Canada
bMediprobe Research Inc. London, Canada
cDepartment of Dermatology, University of Alabama at Birmingham School of Medicine, Birmingham, AL
dDepartment of Dermatology, University of California, San Francisco, CA
eKaken Pharmaceutical Co Ltd, Tokyo, Japan
fValeant Pharmaceuticals North America LLC, Bridgewater, NJ
gDow Pharmaceutical Sciences Inc., Petaluma, CA
hDepartment of Dermatology, Teikyo University School of Medicine, Tokyo, Japan
OBJECTIVES: To investigate the efficacy and safety of efinaconazole 10% solution in pooled Phase III clinical trial participants with mild to moderate onychomycosis.
METHODS: Phase III clinical trials data from NCT01008033 and NCT01007708 were pooled. Efficacy analysis for the primary and secondary outcome variables was conducted using the mITT population and analysed using Cochran-Mantel-Haenszel tests. Subgroup analysis was conducted for prognostic factors that may affect drug efficacy. Safety analysis was conducted on all recipients of a single drug dose.
RESULTS: Efinaconazole 10% nail solution was superior to vehicle for all primary and secondary outcome measures assessed. Complete cure was 18.5% vs 4.7% P<0.001 [mITT] and mycological cure was 56.3% vs 16.6%, P<0.001 [mITT]. Complete or almost complete cure and treatment success were achieved in 27.7% and 47.2% compared to 7.9% and 18.2% with vehicle, respectively (P<0.001 [mITT]). In all subgroups, efinaconazole 10% solution had statistically higher cures rates compared to vehicle. Higher complete cure rates were observed in women and individuals with mild disease (≤33% involvement), but not in any other subgroup assessed. Treatment associated adverse events in the efinaconazole 10% solution group were similar to vehicle and limited to local site reactions (2%).
CONCLUSIONS: The findings from this pooled analysis suggest that efinaconazole 10% solution may become the preferred topical agent for mild to moderate onychomycosis.
J Drugs Dermatol. 2014;13(7):815-820.