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

Study Overview
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Brief Summary
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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.

Detailed Description
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Tinea pedis (Athlete's Foot) is a common skin disease which affects a large number of the population. The development of hygienic socks through the microencapsulation technology have great potential to provide the convenient pharmacological treatment on one hand, and good moisture management which can reduce the microbial overgrowth on the other hand for patients with tinea pedis. The socks, therefore, reduce the effects of the skin disease on the quality of life.

Official Title
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Phase III Study in Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Anti-fungal agent (Clotrimazole) loaded microcapsules
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug loaded microcapsules socks<br>Study medication | Drug: Anti-fungal agent (Clotrimazole) loaded microcapsules<br>* Clotrimazole loaded microcapsules padded on socks and the patient should wear the socks every day for 2 weeks<br>* Other names: Anti-fungal agent loaded microcapsules;|
| Placebo Comparator: No drug loaded microcapsules socks<br>Placebo medication | Drug: Placebo<br>* No drug loaded microcapsules socks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Complete Cure | Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease for each sign and symptom at Day 44. | Day 44 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Treatment | Effective Treatment defined as negative KOH, negative fungal culture, no or mild erythema and/or scaling with all other signs or symptoms being absent at Day 44. | Day 44 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clotrimazole, Microcapsules