Back to resultsThe Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis
Primary Purpose
Onychomycosis
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
CELEXT07
Penlac
vehicle solution
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria
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.
Sites / Locations
- Clinique podiatrique de MontréalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
CELEXT07
placebo
Penlac
Arm Description
suspension that is applied topically to the infected nail(s) daily.
placebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily.
Is a standard of care for the condition and is applied topically to the infected nail(s) daily.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02644551
Brief Title
The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis
Official Title
The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis: a Phase 2, Randomized, Double-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
9305-9954 Quebec Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CELEXT07
Arm Type
Experimental
Arm Description
suspension that is applied topically to the infected nail(s) daily.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo is a suspension that simulates the physical properties of the experimental agent CELEXT07. It is applied topically to the infected nail(s) daily.
Arm Title
Penlac
Arm Type
Active Comparator
Arm Description
Is a standard of care for the condition and is applied topically to the infected nail(s) daily.
Intervention Type
Drug
Intervention Name(s)
CELEXT07
Intervention Type
Drug
Intervention Name(s)
Penlac
Other Intervention Name(s)
topical Penlac nail lacquer
Intervention Type
Other
Intervention Name(s)
vehicle solution
Other Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 52 Weeks
Description
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
Time Frame
week 52
Secondary Outcome Measure Information:
Title
Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 52 Weeks.
Description
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
Time Frame
week 52
Title
Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 52 Weeks.
Description
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.
Time Frame
week 52
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wil Lee, DPM, AACFAS
Phone
514-254-5000
Email
drwlee@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liza Lymberopoulos
Phone
514-254-5000
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline Devaux, MD, FRCPC
Organizational Affiliation
9305-9954 Quebec Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guy Chamberland, M.Sc., Ph.D.
Organizational Affiliation
9305-9954 Quebec Inc
Official's Role
Study Director
Facility Information:
Facility Name
Clinique podiatrique de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1X 2B3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Lee
Phone
514 254-5000
Email
drwlee@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis
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