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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT00253305
Eligibility Criteria:
Inclusion Criteria:
* clinical diagnosis of distal subungual tinuea unguium of one great toenail.
* between 20 - 65% infected area for target nail
* 2 mm of clear nail proximally on target nail
* positive dermatophyte culture and positive KOH test
* able to sign informed consent
* understand requirements of study
* females must be post-menopausal or agree to use approved contraceptives throughout the study
Exclusion Criteria:
* patients with nails infected with organisms other than dermatophytes
* patients with proximal subungual tinea unguium
* patients with spikes of disease extending to nail matrix
* patients with more than 5 infected nails
* patients with confounding problems/ abnormalities of target nail
* patients with screening lab values more than 20% of normal
* patients with known hypersensitivity to test material components
* patients requiring systemic medications that may interfere with study
* patients with a poor history of compliance with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00253305
Study Brief:
Protocol Section:
NCT00253305