The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CELEXT07 suspension that is applied topically to the infected nail(s) daily. |
Drug: CELEXT07
|
| Placebo Comparator: placebo placebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily. |
Other: vehicle solution
Other Names:
|
| Active Comparator: Penlac Is a standard of care for the condition and is applied topically to the infected nail(s) daily. |
Drug: Penlac
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 "Yes"if : 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects are eligible to be included in the study only if they meet all of the following criteria:
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Age > 18.
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Clinically diagnosed onychomycosis of the target nail.
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Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected.
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Has a positive KOH examination from the target nail.
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Has a positive dermatophyte culture from the target nail.
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Written informed consent obtained.
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Subject agreed to follow the protocol.
Exclusion Criteria
Subjects will be excluded from the study if they meet any of the following criteria:
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Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug.
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Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis.
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Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit.
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Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
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Inability to understand and comply with the instructions of the study
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Patients less than age 18
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Individuals with known allergy/hypersensitivity to Thuja occidentalis, Chelidonium majus, Eucalyptus citriodora, Tea tree or Thymus vulgaris.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique podiatrique de Montréal | Montreal | Quebec | Canada | H1X 2B3 |
Sponsors and Collaborators
- 9305-9954 Quebec Inc
Investigators
- Principal Investigator: Céline Devaux, MD, FRCPC, 9305-9954 Quebec Inc
- Study Director: Guy Chamberland, M.Sc., Ph.D., 9305-9954 Quebec Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CELEXT07-01