Status:
COMPLETED
Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
Lead Sponsor:
Prof. Yuen Chun-Wah
Collaborating Sponsors:
Dr. Cheung Hing Cheong Private Dermatology Clinic
Conditions:
Tinea Pedis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 wee...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01524432
Start Date
January 1 2012
End Date
December 1 2012
Last Update
April 2 2013
Active Locations (1)
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1
Institute of Textiles and Clothing, The Hong Kong Polytechnic University
Kowloon, Hong Kong, 00852