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

Information source: The Hong Kong Polytechnic University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tinea Pedis

Intervention: Anti-fungal agent (Clotrimazole) loaded microcapsules (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Prof. Yuen Chun-Wah

Official(s) and/or principal investigator(s):
Chun Wah M. Yuen, Principal Investigator, Affiliation: Hong Kong PU


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: • Complete Cure

Secondary outcome: Effective Treatment

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Institute of Textiles and Clothing, The Hong Kong Polytechnic University, Kowloon 00852, Hong Kong
Additional Information

Starting date: January 2012
Last updated: March 31, 2013

Page last updated: August 23, 2015

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