Clinical trial NCT02644551: The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis
Official title: The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Onychomycosis
Lead sponsor: 9305-9954 Quebec Inc
Sponsor class: INDUSTRY
First posted: 2016-01-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks
timeFrame: week 52
Secondary outcomes:
measure: Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks.
timeFrame: week 52
measure: Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks.
timeFrame: week 52
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: week 52
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique podiatrique de Montréal
state: Quebec
Study officials:
affiliation: 9305-9954 Quebec Inc
name: Céline Devaux, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: 9305-9954 Quebec Inc
name: Guy Chamberland, M.Sc., Ph.D.
role: STUDY_DIRECTOR
References: