Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of hygienic socks with antifungal agent-loaded microcapsules for subjects with interdigital type tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 2 week treatment period and a 4 week follow-up evaluation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Yuen Chun-Wah
• Collaborator: Dr. Cheung Hing Cheong Private Dermatology Clinic
• Treatments: Antifungal Agents; Clotrimazole; Miconazole

Criteria

Inclusion Criteria:

• Be at least 18 years of age and of either sex.

• Subjects must have clinical evidence of interdigital tinea pedis of one or both feet characterized by: (i) moderate erythema, (ii) scaling and (iii) mild pruritis.

• Have microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte in the skin scrapings taken at the Baseline Visit. Subjects with a positive KOH may be entered into the study pending the results of the fungal culture

• Be willing and able to give informed consent/assent or have their parent/guardian do so, if applicable.

• Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.

• Be in good health and free of any disease or physical condition which might, in the Investigator's opinion, expose the subject to an unacceptable risk by study participation.

• Females must be non-pregnant, non-lactating and not intending to become pregnant during the course of the study.

Exclusion Criteria:

• Is pregnant, nursing or planning a pregnancy during the study.

• Has used topical antifungals or topical corticosteroids on the feet within 4 weeks prior to the start of the study.

• Has received systemic antifungal therapy within 4 weeks prior to the start of the study medication.

• Has used systemic antibacterials or systemic corticosteroids within 4 weeks prior to the start of the study. Systemic corticosteroids do not include intranasal, inhaled, and ophthalmic corticosteroids used for the management of allergies, pulmonary disorders or other conditions.

• Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).

• Has concurrent tinea infection e.g. Tinea Versicolor, Tinea Cruris, Moccasin-type Tinea Pedis, etc. (in the opinion of the Investigator).

• Onychomycosis, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.

• Has any other skin disease which might interfere with the evaluation of tinea pedis.

• Is currently enrolled in an investigational drug or device study.

• Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.

• Is unreliable, including subjects with a history of drug or alcohol abuse.

• Has known hypersensitivity to any of the components of the study medications.