The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis

NCT02644551 | Unknown Phase 2

• 1 other identifier: CELEXT07-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks.

  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

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  week 52

Study Arms (3)

CELEXT07

EXPERIMENTAL

suspension that is applied topically to the infected nail(s) daily.

Drug: CELEXT07

placebo

PLACEBO COMPARATOR

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

Penlac

ACTIVE COMPARATOR

Is a standard of care for the condition and is applied topically to the infected nail(s) daily.

Drug: Penlac

Interventions

CELEXT07 DRUG

CELEXT07

Penlac DRUG

Also known as: topical Penlac nail lacquer

Penlac

vehicle solution OTHER

Also known as: placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are eligible to be included in the study only if they meet all of the following criteria:
• Age \> 18.
• Clinically diagnosed onychomycosis of the target nail.
• Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected.
• Has a positive KOH examination from the target nail.
• Has a positive dermatophyte culture from the target nail.
• Written informed consent obtained.
• Subject agreed to follow the protocol.

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the following criteria:
• Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug.
• Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis.
• Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit.
• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
• Inability to understand and comply with the instructions of the study
• Patients less than age 18
• Individuals with known allergy/hypersensitivity to Thuja occidentalis, Chelidonium majus, Eucalyptus citriodora, Tea tree or Thymus vulgaris.

Sponsors & Collaborators

• 9305-9954 Quebec Inc: lead

Study Sites (1)

Clinique podiatrique de Montréal

Montreal, Quebec, H1X 2B3, Canada

RECRUITING

MeSH Terms

Conditions

Onychomycosis

Interventions

Ciclopirox

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyridones; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Céline Devaux, MD, FRCPC

  9305-9954 Quebec Inc

  PRINCIPAL INVESTIGATOR

• Guy Chamberland, M.Sc., Ph.D.

  9305-9954 Quebec Inc

  STUDY DIRECTOR

Central Study Contacts

Wil Lee, DPM, AACFAS

CONTACT

514-254-5000; drwlee@hotmail.com

Liza Lymberopoulos

CONTACT

514-254-5000

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 1, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

CA (1)