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