TABLE 1.
Comparative demographics and background characteristics in pivotal trials (intent-to-treat populations) Ciclopirox 8% nail lacquer1 and efinaconazole 10% solution2
| STUDY 1 | STUDY 2 | STUDY 1 | STUDY 2 | |||||
|---|---|---|---|---|---|---|---|---|
| CICLOPIROX | VEHICLE | CICLOPIROX | VEHICLE | EFINACONAZOLE | VEHICLE | EFINACONAZOLE | VEHICLE | |
| Total patients | 112 | 111 | 119 | 118 | 656 | 214 | 583 | 202 |
| Gender | ||||||||
| Male | 85 (76%) | 90 (81%) | 94 (79%) | 89 (75%) | 489 (75%) | 158 (74%) | 464 (80%) | 164 (82%) |
| Female | 27 (24%) | 21 (19%) | 25 (21%) | 29 (25%) | 167 (25%) | 56 (26%) | 116 (20%) | 37 (18%) |
| Age (years) | ||||||||
| Mean | 50.4 | 48.6 | 37.7 | 38.3 | 52.4 | 51.9 | 50.6 | 50.7 |
| Range | 20–63 | 20–63 | 20–65 | 21–62 | 20–71 | 18–70 | 18–71 | 18–70 |
| Area of target toenail involved (%) | ||||||||
| Mean | 39.6 | 40.3 | 37.7 | 38.3 | 36.7 | 36.8 | 36.2 | 36.7 |
| Range | 20–63 | 20–63 | 20–65 | 21–62 | 20–50 | 20–50 | 20–50 | 20–50 |
1
Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol. 2000;43:S70–S80.
2
Elewski BE, Rich P, Pollak R, et al. Efinaconazole 10% solution in the treatment of toenail onychomycosis: two phase 3 multicenter, randomized, double-blind studies. J Am Acad Dermatol. 2013;68:600–608.