Back to resultsEfficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
Primary Purpose
Onychomycosis of Toenail
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Excilor Forte
Loceryl 5%
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis of Toenail
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 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 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 uncontrolled 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 Forte
Loceryl 5%
Arm Description
Outcomes
Primary Outcome Measures
Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail
Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the percentage of healthy surface (primary efficacy endpoint) of the great toenail was performed to evaluate changes from baseline between both treatment groups. Additionally, blind assessment of the percentage of healthy surface of the great toenail will be performed at all other visits (day 30, 60, and 120, respectively) to evaluate changes from baseline between both treatment groups
Secondary Outcome Measures
Evaluation of clinical efficacy by the investigator, assessing the following parameters: onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening, following treatment with test medical device versus reference product.
Onycholysis, nail distrophy, nail discoloration, and nail thickening was evaluated by a blinded investigator, using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe. Onychomycosis evolution was scored as follows: 1 = failure (aggravation, increase total infected area), 2 = status quo, 3 = improvement (decrease of total infected area), 4 = success: disappearance of the total infected area. In order to compare changes in nail dystrophy, discoloration, and nail thickening between baseline and day 180, five categories were reduced to two categories (none to slight versus moderate to severe). The Mc Nemar test for paired data was used to test if there was a change in nail dystrophy, discoloration, and nail thickening between baseline and day 180. A chi-square test test was performed to compare changes between both treatments in onychomycosis evolution.
Note: scores are used and for this reason, no units of measure can be assigned.
Evaluation of microbiological efficacy of the product, using KOH staining and fungal culture on D0 and D180 versus reference product.
Patients with positive KOH staining were included in the study. In addition, a fungal culture was performed to identify the involved species. At day 180, a new KOH staining and fungal culture was performed to evaluate the impact of each treatment on both microbiological parameters.
Evaluation of product tolerance at each visit during the trial, assessed by the investigator by clinical evaluation and subject interrogatory.
The investigator assigned a score from 0 (bad tolerance) to 3 (very good tolerance).
Evaluation of the quality of life of the subjects using a validated questionnaire (NailQoL) before (baseline), after 60 and 180 days of treatment with test product, versus comparator.
A NailQol global score of 0 corresponds with a quality of life never altered by onychomycosis, whereas a score of 100 corresponds to a quality of life that is always affected by onychomycosis.
Subject evaluation using an evaluation questionnaire, performed at each visit.
A questionnaire was included to evaluate product usability and functionality of Excilor Forte. The questionnaire was completed at each evaluation point (day 30, 60, 120, and 180, respectively). General questions were asked regarding the cosmetic effect (e.g. smoothening, brightening effect, conventional packaging..), overall satisfaction (e.g. smell, fits daily routine ...), product application (e.g. ease of application, drying time, stress-resistance, combination with top coat...), purchase intent and tolerance were asked. Subjects needed to score as follows: strongly agree, agree, neutral, disagree, strongly disagree, not concerned. Data were summarized in frequencies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03382717
Brief Title
Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
Official Title
Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 26, 2016 (Actual)
Primary Completion Date
August 26, 2017 (Actual)
Study Completion Date
August 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oystershell NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effect of the medical device "Excilor® Forte" 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 of Toenail
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Excilor Forte
Arm Type
Experimental
Arm Title
Loceryl 5%
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Excilor Forte
Intervention Description
1 application per day during 6 months
Intervention Type
Drug
Intervention Name(s)
Loceryl 5%
Intervention Description
1 application per week during 6 months
Primary Outcome Measure Information:
Title
Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail
Description
Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the percentage of healthy surface (primary efficacy endpoint) of the great toenail was performed to evaluate changes from baseline between both treatment groups. Additionally, blind assessment of the percentage of healthy surface of the great toenail will be performed at all other visits (day 30, 60, and 120, respectively) to evaluate changes from baseline between both treatment groups
Time Frame
After 30, 60, 120 and 180 days of treatment
Secondary Outcome Measure Information:
Title
Evaluation of clinical efficacy by the investigator, assessing the following parameters: onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening, following treatment with test medical device versus reference product.
Description
Onycholysis, nail distrophy, nail discoloration, and nail thickening was evaluated by a blinded investigator, using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe. Onychomycosis evolution was scored as follows: 1 = failure (aggravation, increase total infected area), 2 = status quo, 3 = improvement (decrease of total infected area), 4 = success: disappearance of the total infected area. In order to compare changes in nail dystrophy, discoloration, and nail thickening between baseline and day 180, five categories were reduced to two categories (none to slight versus moderate to severe). The Mc Nemar test for paired data was used to test if there was a change in nail dystrophy, discoloration, and nail thickening between baseline and day 180. A chi-square test test was performed to compare changes between both treatments in onychomycosis evolution.
Note: scores are used and for this reason, no units of measure can be assigned.
Time Frame
After 30, 60, 120 and 180 days of treatment
Title
Evaluation of microbiological efficacy of the product, using KOH staining and fungal culture on D0 and D180 versus reference product.
Description
Patients with positive KOH staining were included in the study. In addition, a fungal culture was performed to identify the involved species. At day 180, a new KOH staining and fungal culture was performed to evaluate the impact of each treatment on both microbiological parameters.
Time Frame
At baseline (day 0) and after 180 days of treatment
Title
Evaluation of product tolerance at each visit during the trial, assessed by the investigator by clinical evaluation and subject interrogatory.
Description
The investigator assigned a score from 0 (bad tolerance) to 3 (very good tolerance).
Time Frame
After 30, 60, 120 and 180 days of treatment
Title
Evaluation of the quality of life of the subjects using a validated questionnaire (NailQoL) before (baseline), after 60 and 180 days of treatment with test product, versus comparator.
Description
A NailQol global score of 0 corresponds with a quality of life never altered by onychomycosis, whereas a score of 100 corresponds to a quality of life that is always affected by onychomycosis.
Time Frame
After 60 and 180 days of treatment
Title
Subject evaluation using an evaluation questionnaire, performed at each visit.
Description
A questionnaire was included to evaluate product usability and functionality of Excilor Forte. The questionnaire was completed at each evaluation point (day 30, 60, 120, and 180, respectively). General questions were asked regarding the cosmetic effect (e.g. smoothening, brightening effect, conventional packaging..), overall satisfaction (e.g. smell, fits daily routine ...), product application (e.g. ease of application, drying time, stress-resistance, combination with top coat...), purchase intent and tolerance were asked. Subjects needed to score as follows: strongly agree, agree, neutral, disagree, strongly disagree, not concerned. Data were summarized in frequencies.
Time Frame
After 30, 60, 120 and 180 days of treatment
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 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 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 uncontrolled 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
Plan to Share IPD
No
Citations:
PubMed Identifier
30051298
Citation
Eertmans F, Doss N, Rossel B, Adriaens E. Daily Application of an Aqueous, Acidifying, Peelable Nail Polish versus Weekly Amorolfine for Topical Onychomycosis Treatment: A Prospective, Randomized, Blinded Trial. Dermatol Ther (Heidelb). 2018 Sep;8(3):463-473. doi: 10.1007/s13555-018-0254-1. Epub 2018 Jul 26.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
We'll reach out to this number within 24 hrs