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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Clinique podiatrique de Montréal
Montreal, Quebec, Canada
RECRUITINGEfficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes. and no residual involvement of the target toenail. The complete cure is a composite binary variable defined as "Yes" if: * Mycological cure (negative KOH and negative culture for dermatophytes) and * No residual involvement of the target toenail "No" if otherwise
Time frame: week 52
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks.
Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and \<= 10% residual involvement of the target toenail.Clinical effectiveness is a composite binary variable defined as "Yes" if * Mycological cure (negative KOH and negative culture for dermatophytes) and ◦= 10% residual involvement of the target toenail "No" if otherwise
Time frame: week 52
Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks.
Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes. Mycological cure is a composite binary variable defined as "Yes"if : * Negative microscopy and * Negative culture for dermatophytes "No" if otherwise.
Time frame: week 52
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: week 52
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