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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT07056660
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 70 years, irrespective of sex.
* Clinical diagnosis of interdigital tinea pedis (non-hyperkeratotic type), with or without extension to other areas, of moderate to severe intensity, defined as follows: target lesion(s) will have an erythema score of ≥2 and either a desquamation or pruritus score of ≥2, with a total score ≥4 (using a 0-3 scale for each item).
* Positive direct potassium hydroxide (KOH) microscopic examination for dermatophytes.
* Women of childbearing potential will agree to use effective contraception throughout the study period.
* Written informed consent will be obtained prior to enrollment.
Exclusion Criteria:
* Severe bacterial infection or other dermatological conditions that may interfere with study assessments.
* Serious cardiac, hepatic, or renal diseases, diabetes mellitus, or major psychiatric disorders.
* Systemic corticosteroid or immunosuppressant use within the past 3 months.
* Systemic antifungal agents within the past 2 months or topical antifungal agents within the past 2 weeks.
* Pregnancy or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07056660
Study Brief:
Protocol Section:
NCT07056660