Onychomycosis
Conditions
Brief 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.
Interventions
Sponsors
9305-9954 Quebec Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects are eligible to be included in the study only if they meet all of the following criteria: 1. Age \> 18. 2. Clinically diagnosed onychomycosis of the target nail. 3. Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected. 4. Has a positive KOH examination from the target nail. 5. Has a positive dermatophyte culture from the target nail. 6. Written informed consent obtained. 7. Subject agreed to follow the protocol.
Exclusion criteria
Subjects will be excluded from the study if they meet any of the following criteria: 1. Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug. 2. Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis. 3. Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit. 4. Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period. 5. Inability to understand and comply with the instructions of the study 6. Patients less than age 18 7. Individuals with known allergy/hypersensitivity to Thuja occidentalis, Chelidonium majus, Eucalyptus citriodora, Tea tree or Thymus vulgaris.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks | week 52 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks. | week 52 | 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 |
| Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks. | week 52 | Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes. Mycological cure is a composite binary variable defined as Yesif : * Negative microscopy and * Negative culture for dermatophytes No if otherwise. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | week 52 | — |
Countries
Canada
Contacts
Primary ContactWil Lee, DPM, AACFAS
Backup ContactLiza Lymberopoulos
Outcome results
None listed