Dr. Cook-Bolden is from Skin Specialty Dermatology, New York, New York. Dr. Lin is from Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey.
Dr. Cook-Bolden was a principle investigator in the study and has served as an advisory board member, researcher, and speaker for Valeant Pharmaceuticals North America LLC. Dr. Lin is an employee and shareholder of Valeant Pharmaceuticals North America LLC.
Correspondence: Fran E. Cook-Bolden, MD, Skin Specialty Dermatology, 150 E 58th St, New York, NY 10155 (skinspecialtydermatology@gmail.com).
At week 52, 25.6% of Latino participants in the efinaconazole group achieved complete cure versus 0% in the vehicle group (P<.001)(Figure 1). The efficacy of efinaconazole was statistically superior in Latino participants versus non-Latino participants (17.2% [P=.012]). The net effect (calculated by active treatment minus vehicle) for Latino participants also was superior to non-Latino participants (25.6% vs 11.6%).
Figure 1. Primary efficacy end point of complete cure at week 52 (intention-to-treat pooled data) for Latino and non-Latino subpopulations. Asterisk indicates P<.001 vs vehicle; dagger, P=.012 between the 2 efina-conazole groups.
Secondary Efficacy End Points (OC)
At week 52, 61.5% of Latino participants in the efina-conazole group achieved mycologic cure versus 15.3% in the vehicle group (P<.001)(Figure 2). The net effect for Latino participants was superior to non-Latino participants (46.2% vs 38.5%). More Latino participants in the efinaconazole group compared to vehicle group achieved complete/almost complete cure (32.7% vs 1.7%) or treatment success (49.4% vs 5.1%)(all P<.001)(Figure 3). Although there was no significant difference between the 2 groups for secondary efficacy end points, the net effect of efinaconazole was greater for all end points.
Figure 2. Secondary efficacy end point of mycologic cure at week 52 (intention-to-treat pooled data) for Latino and non-Latino subpopulations. Asterisk indicates P<.001 vs vehicle; dagger, P=.154 between the 2 efina-conazole groups.
Figure 3. Secondary efficacy end point of treatment success (≤10% clinical involvement of target toenail) at week 52 (intention-to-treat pooled data) for Latino and non-Latino subpopulations. Asterisk indicates P<.001 vs vehicle; dagger, P=.559 between the 2 efinaconazole groups.
Safety
Adverse event rates were higher in the efinaconazole group than the vehicle group (65.3% vs 54.4%) and were similar in both populations; they were generally mild (61.8% vs 54.5%) or moderate (35.3% vs 45.5%) in severity, not related to study medication (96.8% vs 98.0%), and resolved without sequelae. Only 3 Latino participants (1.6%) discontinued efinaconazole treatment compared to 29 (2.8%) in the non-Latino population.
