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:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT02644551
Eligibility Criteria:
Inclusion Criteria:
Subjects are eligible to be included in the study only if they meet all of the following criteria:
1. Age \> 18.
2. Clinically diagnosed onychomycosis of the target nail.
3. Presence of mild to moderate onychomycosis, defined as 20-50% of the area of the target nail being clinically affected.
4. Has a positive KOH examination from the target nail.
5. Has a positive dermatophyte culture from the target nail.
6. Written informed consent obtained.
7. Subject agreed to follow the protocol.
Exclusion Criteria
Subjects will be excluded from the study if they meet any of the following criteria:
1. Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug.
2. Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis.
3. Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit.
4. Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
5. Inability to understand and comply with the instructions of the study
6. Patients less than age 18
7. Individuals with known allergy/hypersensitivity to Thuja occidentalis, Chelidonium majus, Eucalyptus citriodora, Tea tree or Thymus vulgaris.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02644551
Study Brief:
Protocol Section:
NCT02644551