The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis

Onychomycosis Clinical Trial

Official title:

The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02644551
• Other study ID #: CELEXT07-01
• Status: Recruiting
• Phase: Phase 2
• First received: December 29, 2015
• Last updated: April 24, 2017
• Start date: November 2016
• Est. completion date: September 2018

Study information

• Verified date: April 2017
• Source: 9305-9954 Quebec Inc
• Contact: Wil Lee, DPM, AACFAS
• Phone: 514-254-5000
• Email: drwlee[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• CELEXT07

• Penlac

Other:
• vehicle solution

Locations

Country	Name	City	State
Canada	Clinique podiatrique de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
9305-9954 Quebec Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy 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	week 52
Secondary	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	week 52
Secondary	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.	week 52
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		week 52