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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT03405818
Eligibility Criteria:
Inclusion Criteria:
* males or females, ages \>/= 6 years and \</= 16 years and 11 months
* clinical diagnosis of distal subungual onychomycosis affecting at least 20% of one of the great toenails (target nail); and with positive KOH and positive culture for T. rubrum or T. mentagrophytes from either great toenail
Exclusion Criteria:
* the target toenail has proximal subungual onychomycosis, onychomycosis involving the nail lunula, superficial white onychomycosis, dermatophytoma, exclusively lateral disease, or yellow or brown spikes, or has co-infection with certain fungi or molds
* anatomic abnormalities of the toes or toenail
* current or past history of chronic moccasin-type tinea pedis
* current or past history of psoriasis or lichen planus
* history of significant chronic fungal disease (other than onychomycosis)
* diabetes
* immunodeficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
72 Months
Maximum Age:
203 Months
Study:
NCT03405818
Study Brief:
Protocol Section:
NCT03405818