Tinea PedisPhase 1NCT01524432
Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
A Phase 1 study testing Anti-fungal agent (Clotrimazole) loaded microcapsules in people with Tinea Pedis, run by Prof. Yuen Chun-Wah at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Anti-fungal agent (Clotrimazole) loaded microcapsules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2012to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Institute of Textiles and Clothing, The Hong Kong Polytechnic University
Kowloon, 00852
About this study
Official title: Phase III Study in 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.
Read the 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.
- Conditions
- Tinea Pedis
- Being tested
- Anti-fungal agent (Clotrimazole) loaded microcapsules, Placebo
- Keywords
- Clotrimazole, Microcapsules
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-fungal agent (Clotrimazole) loaded microcapsulesDrug
Also called Anti-fungal agent loaded microcapsules
Clotrimazole loaded microcapsules padded on socks and the patient should wear the socks every day for 2 weeks
PlaceboDrug
No drug loaded microcapsules socks
| Study group | Role | What they receive |
|---|---|---|
| Drug loaded microcapsules socks | Experimental | Study medication Receives: Drug: Anti-fungal agent (Clotrimazole) loaded microcapsules |
| No drug loaded microcapsules socks | Placebo comparator | Placebo medication Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: Day 44
Secondary outcomes (1)
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.
Measured: Day 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Yuen Chun-Wah
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Cheung Hing Cheong Private Dermatology Clinic
- Responsible party
- Sponsor-investigator, Prof. Yuen Chun-Wah, The Hong Kong Polytechnic University
- Investigators
- Chun Wah M. Yuen, Principal investigator, Hong Kong PU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524432
- Sponsor's protocol ID
- Mic_Clo_Terb
- Status last verified
- Mar 2013
- First submitted
- 18 Jan 2012
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study in Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
- ClinicalTrials.gov ID
- NCT01524432
- Acronym / sponsor ID
- Mic_Clo_Terb
- Conditions
- Tinea Pedis
- Keywords
- Clotrimazole, Microcapsules
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Prof. Yuen Chun-WahUniversity, hospital or other
- Collaborators
- Dr. Cheung Hing Cheong Private Dermatology Clinic
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug loaded microcapsules socks | Experimental | Drug: Anti-fungal agent (Clotrimazole) loaded microcapsulesStudy medication |
| No drug loaded microcapsules socks | Placebo comparator | Drug: PlaceboPlacebo medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-fungal agent (Clotrimazole) loaded microcapsulesAlso: Anti-fungal agent loaded microcapsulesClotrimazole loaded microcapsules padded on socks and the patient should wear the socks every day for 2 weeks | Drug | Drug loaded microcapsules socks |
| PlaceboNo drug loaded microcapsules socks | Drug | No drug loaded microcapsules socks |
Primary outcome
• 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.
1 secondary outcome
Effective Treatment
Time frame: Day 44
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Wah M. Yuen principal investigator
Hong Kong PU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-fungal agent (Clotrimazole) loaded microcapsules in people with Tinea Pedis, run by Prof. Yuen Chun-Wah at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Complete Cure (time frame: Day 44). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013.