- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03382717
Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tunis, Tunisia
- Hospital Habib Thameur
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Tunis, Tunisia
- Principal instruction military hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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…).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Excilor Forte
One application of the MD daily (at same time point), preferably after showering/bathing, during the complete study period.
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1 application per day during 6 months
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Active Comparator: Loceryl 5%
One application per week of the positive control Loceryl 5% during the whole study period.
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1 application per week during 6 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: After 30, 60, 120 and 180 days of treatment
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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
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After 30, 60, 120 and 180 days of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: After 30, 60, 120 and 180 days of treatment
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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. |
After 30, 60, 120 and 180 days of treatment
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Evaluation of microbiological efficacy of the product, using KOH staining and fungal culture on D0 and D180 versus reference product.
Time Frame: At baseline (day 0) and after 180 days of treatment
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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.
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At baseline (day 0) and after 180 days of treatment
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Evaluation of product tolerance at each visit during the trial, assessed by the investigator by clinical evaluation and subject interrogatory.
Time Frame: After 30, 60, 120 and 180 days of treatment
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The investigator assigned a score from 0 (bad tolerance) to 3 (very good tolerance).
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After 30, 60, 120 and 180 days of treatment
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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.
Time Frame: After 60 and 180 days of treatment
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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.
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After 60 and 180 days of treatment
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Subject evaluation using an evaluation questionnaire, performed at each visit.
Time Frame: After 30, 60, 120 and 180 days of treatment
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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.
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After 30, 60, 120 and 180 days of treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nejib Doss, MD, Principal Instruction military hospital of Tunis
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16E1078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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