The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis

Phase 2

• Conditions: Onychomycosis
• Interventions: Drug: CELEXT07; Other: vehicle solution; Drug: Penlac

• Registration Number: NCT02644551
• Lead Sponsor: 9305-9954 Quebec Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-29
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2016-01-01
• Study Start: 2016-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2018-05
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CELEXT07	CELEXT07	suspension that is applied topically to the infected nail(s) daily.
placebo	vehicle solution	placebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily.
Penlac	Penlac	Is a standard of care for the condition and is applied topically to the infected nail(s) daily.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	week 52
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.

Trial Locations

Locations (1)

Clinique podiatrique de Montréal; 🇨🇦 Montreal, Quebec, Canada