The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis

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

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.

Study Overview

• Status: Unknown
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: CELEXT07; Other: vehicle solution; Drug: Penlac

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wil Lee, DPM, AACFAS; Phone Number: 514-254-5000; Email: drwlee@hotmail.com
• Study Contact Backup: Name: Liza Lymberopoulos; Phone Number: 514-254-5000

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1X 2B3
      • Recruiting
      • Clinique podiatrique de Montréal
      • Contact: William Lee; Phone Number: 514 254-5000; Email: drwlee@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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: placebo
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: topical Penlac nail lacquer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		week 52

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: December 29, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis; Anti-Infective Agents; Antifungal Agents; Ciclopirox
• Other Study ID Numbers: CELEXT07-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided