Back to resultsHygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
Primary Purpose
Tinea Pedis
Status
Completed
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
Anti-fungal agent (Clotrimazole) loaded microcapsules
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Pedis focused on measuring Clotrimazole, Microcapsules
Eligibility Criteria
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.
Sites / Locations
- Institute of Textiles and Clothing, The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Drug loaded microcapsules socks
No drug loaded microcapsules socks
Arm Description
Study medication
Placebo medication
Outcomes
Primary Outcome Measures
• 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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01524432
First Posted
January 18, 2012
Last Updated
March 31, 2013
Sponsor
Prof. Yuen Chun-Wah
Collaborators
Dr. Cheung Hing Cheong Private Dermatology Clinic
1. Study Identification
Unique Protocol Identification Number
NCT01524432
Brief Title
Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
Official Title
Phase III Study in Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Yuen Chun-Wah
Collaborators
Dr. Cheung Hing Cheong Private Dermatology Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis
Keywords
Clotrimazole, Microcapsules
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug loaded microcapsules socks
Arm Type
Experimental
Arm Description
Study medication
Arm Title
No drug loaded microcapsules socks
Arm Type
Placebo Comparator
Arm Description
Placebo medication
Intervention Type
Drug
Intervention Name(s)
Anti-fungal agent (Clotrimazole) loaded microcapsules
Other Intervention Name(s)
Anti-fungal agent loaded microcapsules
Intervention Description
Clotrimazole loaded microcapsules padded on socks and the patient should wear the socks every day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
No drug loaded microcapsules socks
Primary Outcome Measure Information:
Title
• Complete Cure
Description
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.
Time Frame
Day 44
Secondary Outcome Measure Information:
Title
Effective Treatment
Description
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.
Time Frame
Day 44
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Wah M. Yuen
Organizational Affiliation
Hong Kong PU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Textiles and Clothing, The Hong Kong Polytechnic University
City
Kowloon
ZIP/Postal Code
00852
Country
Hong Kong
12. IPD Sharing Statement
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Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
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