Back to resultsClinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis
Primary Purpose
Onychomycosis
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Excilor
Loceryl 5%
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- Subject having given her/his informed, written consent,
- Subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
- Subject being psychologically able to understand information and to give their/his/her consent.
- Age: more than 18 years.
- Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablet).
- Subject with positive results of KOH staining.
- Subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
- Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
Exclusion Criteria:
- Subject considered by the Investigator likely to be non-compliant with the protocol.
- Patient enrolled in another clinical trial during the test period.
- Woman being pregnant, nursing or planning a pregnancy during the course of this study.
- Subject having a known allergy to one of the constituents of the tested products.
- Patient suffering from serious or progressive diseases (to investigator's discretion), such as diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology….
- Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Sites / Locations
- Hospital Habib Thameur
- Principal instruction military hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Excilor
Loceryl 5%
Arm Description
2 applications per day for 6 months
1 application per week for 6 months
Outcomes
Primary Outcome Measures
At the end of the study (day 168), evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
Secondary Outcome Measures
At different time points, evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
Evaluation of the clinical efficacy assessed by the investigator with structured scales. Comparison with the comparator product.
Onycholysis, nail dystrophy, nail discoloration and nail thickening were assessed using the following scores:
0 = none, 1 = very slight, 2 = slight, 3 =moderate, and 4 = severe.
Evaluation of the microbiological efficacy of the product assessed by fungal culture and comparison with the comparator product.
Evaluation of the product tolerance, assessed by the investigator by clinical evaluation and subject interrogatory with a score from 0 (bad tolerance) to 3 (very good tolerance).
Evaluation of the quality of life of the subjects thanks to the questionnaire NailQoL . Comparison with the comparator product.
Subjective evaluation by subjects by completing the subjective evaluation questionnaire at each visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03289871
Brief Title
Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis
Official Title
Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oystershell NV
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effect of the medical device "Excilor® Fungal Nail Infection" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Excilor
Arm Type
Experimental
Arm Description
2 applications per day for 6 months
Arm Title
Loceryl 5%
Arm Type
Active Comparator
Arm Description
1 application per week for 6 months
Intervention Type
Device
Intervention Name(s)
Excilor
Intervention Type
Drug
Intervention Name(s)
Loceryl 5%
Primary Outcome Measure Information:
Title
At the end of the study (day 168), evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
Description
Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
Time Frame
After 168 days of treatment
Secondary Outcome Measure Information:
Title
At different time points, evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
Description
Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
Time Frame
After 14, 28, 56 and 112 days of treatment
Title
Evaluation of the clinical efficacy assessed by the investigator with structured scales. Comparison with the comparator product.
Description
Onycholysis, nail dystrophy, nail discoloration and nail thickening were assessed using the following scores:
0 = none, 1 = very slight, 2 = slight, 3 =moderate, and 4 = severe.
Time Frame
On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
Title
Evaluation of the microbiological efficacy of the product assessed by fungal culture and comparison with the comparator product.
Time Frame
On baseline (day zero) and day 168
Title
Evaluation of the product tolerance, assessed by the investigator by clinical evaluation and subject interrogatory with a score from 0 (bad tolerance) to 3 (very good tolerance).
Time Frame
After 14, 28, 56 and 112 days of treatment
Title
Evaluation of the quality of life of the subjects thanks to the questionnaire NailQoL . Comparison with the comparator product.
Time Frame
On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
Title
Subjective evaluation by subjects by completing the subjective evaluation questionnaire at each visit.
Time Frame
On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject having given her/his informed, written consent,
Subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
Subject being psychologically able to understand information and to give their/his/her consent.
Age: more than 18 years.
Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablet).
Subject with positive results of KOH staining.
Subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
Exclusion Criteria:
Subject considered by the Investigator likely to be non-compliant with the protocol.
Patient enrolled in another clinical trial during the test period.
Woman being pregnant, nursing or planning a pregnancy during the course of this study.
Subject having a known allergy to one of the constituents of the tested products.
Patient suffering from serious or progressive diseases (to investigator's discretion), such as diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology….
Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nejib Doss, MD
Organizational Affiliation
Principal Instruction military hospital of Tunis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Habib Thameur
City
Tunis
Country
Tunisia
Facility Name
Principal instruction military hospital
City
Tunis
Country
Tunisia
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis
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