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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT01891305
Eligibility Criteria:
Key Inclusion Criteria:
* Healthy male and non-pregnant female patients ≥18 years and \<65 years
* Clinical diagnosis of tinea pedis
* Positive baseline KOH
* Clinical signs and symptoms score of the target lesion is at least 6, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity)
* Patients must be able to swallow capsules intact
* Use acceptable birth control methods
Key Exclusion Criteria:
* Major organ system disease or clinical infection
* Poorly controlled diabetes mellitus
* Pregnant or lactating
* Confluent, diffuse moccasin-type tinea pedis
* Presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail
* Recent use of topical corticosteroids, topical antibiotics, or topical antifungal therapy to the foot
* Recent use of systemic corticosteroids or antifungal therapy
* Known(HIV)infection
* Known significant hepatic, or hematologic impairment .Requirement for treatment with concomitant antimicrobial or systemic antifungal therapy for any reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01891305
Study Brief:
Protocol Section:
NCT01891305