Phase III Study in Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- • Complete Cure
Study Overview
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 week treatment period and a 4 week follow-up evaluation.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Drug loaded microcapsules socks
Study medication
Intervention: Anti-fungal agent (Clotrimazole) loaded microcapsules (Drug)
No drug loaded microcapsules socks
Placebo medication
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
• Complete Cure
Time Frame: Day 44
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.
Secondary Outcomes
- Effective Treatment(Day 44)
Investigators
Prof. Yuen Chun-Wah
Professor
The Hong Kong Polytechnic University