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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02132260
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant, non-lactating females 18 years or older
* Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot
* The presence of interdigital tinea pedis infection
* The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus
Exclusion Criteria:
* Females who are pregnant, lactating or planning to become pregnant during the study period
* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit
* Use of topical corticosteroids, antibiotics or antifungal therapies within two weeks prior to baseline visit
* Use of systemic corticosteroids, antibiotics or antifungal therapies within one month prior to baseline visit
* Use of oral terbinafine or itraconazole within two months prior to baseline visit
* Use of immunosuppressive medication or radiation therapy within three months prior to baseline visit
* Any known hypersensitivity to Naftifine Hydrochloride, or any component of the formulation
* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
* History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place undue risk by participation or could jeopardize the integrity of study evaluations
* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with tinea pedis evaluation
* Past history of dermatophyte infections with a lack of response ot antifungal therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02132260
Study Brief:
Protocol Section:
NCT02132260