The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis
Status:
Unknown status
Trial end date:
2018-09-01
Target enrollment:
Participant gender:
Summary
This will be an interventional safety and efficacy study of CELENT07 when used as a topical
treatment of onychomycosis in the toenails (tinea unguium) of adults 18 years and older. This
is randomized, double-blind, parallel design, placebo and active controlled study in patients
with mild to moderate toenail distal lateral subungual onychomycosis (DLSO) (n=120). Subjects
will be randomized (1:1:1) to receive CELENXT07, placebo of CELENXT07 or PENLAC®, daily for
52 weeks. Efficacy assessments will include complete cure, mycologic cure and clinical
efficacy and safety and tolerability.