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The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis

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ClinicalTrials.gov Identifier: NCT02644551
Recruitment Status : Unknown
Verified April 2017 by 9305-9954 Quebec Inc.
Recruitment status was:  Recruiting
First Posted : January 1, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
9305-9954 Quebec Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: CELEXT07 Drug: Penlac Other: vehicle solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study
Actual Study Start Date : November 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

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Arms and Interventions
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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 Name: 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 Name: topical Penlac nail lacquer


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks [ Time Frame: 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 :
  1. Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks. [ Time Frame: 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

  2. Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks. [ Time Frame: 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.

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644551


Contacts
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Contact: Wil Lee, DPM, AACFAS 514-254-5000 drwlee@hotmail.com
Contact: Liza Lymberopoulos 514-254-5000

Locations
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Canada, Quebec
Clinique podiatrique de Montréal Recruiting
Montreal, Quebec, Canada, H1X 2B3
Contact: William Lee    514 254-5000    drwlee@hotmail.com   
Sponsors and Collaborators
9305-9954 Quebec Inc
Investigators
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Principal Investigator: Céline Devaux, MD, FRCPC 9305-9954 Quebec Inc
Study Director: Guy Chamberland, M.Sc., Ph.D. 9305-9954 Quebec Inc
More Information
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Responsible Party: 9305-9954 Quebec Inc
ClinicalTrials.gov Identifier: NCT02644551    
Other Study ID Numbers: CELEXT07-01
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
 Nail Diseases
Skin Diseases
Ciclopirox
Antifungal Agents
Anti-Infective Agents