Phase
Condition
Athlete's Foot (Tinea Pedis)
Fungal Infections
Yeast Infections
Treatment
N/AClinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or nonpregnant females aged 18-60 years old.
Clinical diagnosis of tinea pedis (total sign/symptom score >2), lesions between thetoes, with possible extension to the lateral surfaces and soles of the feet confirmedby a positive microscopy prior to dosing.
Willing to sign the informed consent.
Exclusion
Exclusion Criteria:
Females who are pregnant (confirmed by a pregnancy test), suspect themselves to bepregnant (even if pregnancy test is negative), breast-feeding, or planning apregnancy.
Signs of systemic or other superficial fungal disease (e.g.onychomycosis), clinicallyrelevant abnormal findings upon physical examination of the foot or previous treatmentwith a disallowed medication (such as corticosteroids).
Presence of non-healing wounds and/or bacterial infection on the feet.
Secondary bacterial infection due to tinea pedis
Presence of pigmentation, extensive scarring, or pigmented lesions in the treatmentareas, which could interfere with the rating of efficacy parameters.
History of hypersensitivity to any component of the test products.
Current imuunosuppression. Specifically, these include patients with co-morbiditiessuch as diabetes, HIV, chronic diseases requiring maintenance medications, acutefebrile/infectious illnesses (i.e. Dengue, pneumonia, etc)
Use within 3 months prior to baseline of: 1.) chemotherapy, or 2.) radiation therapy
Study Design
Connect with a study center
Clinical Trial Management and Testing Associates, Inc.
Muntinlupa,
PhilippinesActive - Recruiting
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