Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT02961634
Eligibility Criteria:
Inclusion Criteria:
* Volunteers of both sexes;
* Volunteers aged 18-65 years;
* Volunteers with onychomycosis confirmed by positive direct mycological nail of hands or feet;
* Agreement to comply with the test procedures and attend the clinic in the days and times for certain applications and / or assessments;
* Understand, consent and sign the Instrument of Consent of Clarified.
Exclusion Criteria:
* Pregnancy or risk pregnancy / lactation;
* Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
* Concomitant nail pathologies (psoriasis, lichen planus, etc.);
* Systemic conditions that may compromise the growth of the nail (vascular disease, diabetes, etc.);
* Irritation History to similar products to the investigational product;
* Treatment with antifungal medication prior to the study (up to 12 weeks for systemic medications and topical medications for four weeks);
* Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02961634
Study Brief:
Protocol Section:
NCT02961634