target toenail. Data are presented for the pooled Intent-to-Treat (ITT) population.
RESULTS
Subject demographics are summarized in Table 1. The numbers of patients in each group assessed were comparable (range, 279-354). There were no obvious differences in terms of demographics.
Overall, the mean percent affected target toenail at baseline was comparable between efinaconazole and vehicle (36.4% and 36.7% respectively). Over the duration of the 48-week study, and 4-week follow-up the mean percent affected target toenail changed very little with vehicle (only a 1% reduction from baseline to study end). In contrast, the mean percent affected target toenail following efinaconazole treatment was 20.6% at week 52, a 43% reduction (Figure 1).
Improvement in affected target toenail with efinaconazole at week 52 was greater in females, although the trajectory for the male cohort was similar. Both genders showed significant improvement (active versus vehicle) from week 12 (P=.001 [males] and P=.034 [females] and both P<.001 from week 24). At week 52, mean percent affected target toenail was 14.4% Bhatia(females) and 20.6% (males), a 60% and 44% reduction respectively, see Figure 2A. Differences were less marked with respect to age. Younger patients (<45 years old) tended to do slightly better, with a mean percent affected target toenail of 16.0% following efinaconazole treatment, compared with 20.2% in the older cohort (P=.185 [<45 years] and P<.001 [≥45 years] active versus vehicle at week 12; and both P<.001 active versus vehicle from week 24, see Figure 2B). Similar findings are observed in the assessment of patients with diabetes. Those patients where co-existing diabetes was recorded at
