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

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ClinicalTrials.gov Identifier: NCT01524432
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : April 2, 2013
Sponsor:
Collaborator:
Dr. Cheung Hing Cheong Private Dermatology Clinic
Information provided by (Responsible Party):
Prof. Yuen Chun-Wah, The Hong Kong Polytechnic University

Tracking Information
First Submitted Date  ICMJE January 18, 2012
First Posted Date  ICMJE February 2, 2012
Last Update Posted Date April 2, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
• 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01524432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
Effective Treatment [ Time Frame: Day 44 ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
Official Title  ICMJE Phase III Study in Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tinea Pedis
Intervention  ICMJE
  • Drug: Anti-fungal agent (Clotrimazole) loaded microcapsules
    Clotrimazole loaded microcapsules padded on socks and the patient should wear the socks every day for 2 weeks
    Other Name: Anti-fungal agent loaded microcapsules
  • Drug: Placebo
    No drug loaded microcapsules socks
Study Arms  ICMJE
  • Experimental: Drug loaded microcapsules socks
    Study medication
    Intervention: Drug: Anti-fungal agent (Clotrimazole) loaded microcapsules
  • Placebo Comparator: No drug loaded microcapsules socks
    Placebo medication
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2013)
42
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2012)
100
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01524432
Other Study ID Numbers  ICMJE Mic_Clo_Terb
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Yuen Chun-Wah, The Hong Kong Polytechnic University
Study Sponsor  ICMJE Prof. Yuen Chun-Wah
Collaborators  ICMJE Dr. Cheung Hing Cheong Private Dermatology Clinic
Investigators  ICMJE
Principal Investigator: Chun Wah M. Yuen Hong Kong PU
PRS Account The Hong Kong Polytechnic University
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP