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

This study has been completed.
Sponsor:
Collaborator:
Dr. Cheung Hing Cheong Private Dermatology Clinic
Information provided by (Responsible Party):
Prof. Yuen Chun-Wah, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01524432
First received: January 18, 2012
Last updated: March 31, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Tinea Pedis
Drug: Anti-fungal agent (Clotrimazole) loaded microcapsules
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study in Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • • Complete Cure [ Time Frame: Day 44 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 44 ] [ Designated as safety issue: No ]
    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.


Enrollment: 42
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug loaded microcapsules socks
Study medication
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
Placebo Comparator: No drug loaded microcapsules socks
Placebo medication
Drug: Placebo
No drug loaded microcapsules socks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524432

Locations
Hong Kong
Institute of Textiles and Clothing, The Hong Kong Polytechnic University
Kowloon, Hong Kong, 00852
Sponsors and Collaborators
Prof. Yuen Chun-Wah
Dr. Cheung Hing Cheong Private Dermatology Clinic
Investigators
Principal Investigator: Chun Wah M. Yuen Hong Kong PU
  More Information

No publications provided

Responsible Party: Prof. Yuen Chun-Wah, Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01524432     History of Changes
Other Study ID Numbers: Mic_Clo_Terb
Study First Received: January 18, 2012
Last Updated: March 31, 2013
Health Authority: Hong Kong: Department of Health
Hong Kong: Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:
Clotrimazole
Microcapsules

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Foot Dermatoses
Foot Diseases
Infection
Mycoses
Pruritus
Signs and Symptoms
Skin Diseases
Skin Diseases, Infectious
Skin Manifestations
Antifungal Agents
Miconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014