Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis
NCT ID: NCT03289871
Last Updated: 2017-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
112 participants
INTERVENTIONAL
2015-01-31
2015-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Excilor
2 applications per day for 6 months
Excilor
Loceryl 5%
1 application per week for 6 months
Loceryl 5%
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Excilor
Loceryl 5%
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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…).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oystershell NV
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nejib Doss, MD
Role: PRINCIPAL_INVESTIGATOR
Principal Instruction military hospital of Tunis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Habib Thameur
Tunis, , Tunisia
Principal instruction military hospital
Tunis, , Tunisia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14E0752
Identifier Type: -
Identifier Source: org_study_id