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Trial record 22 of 27 for:    Clotrimazole AND Fungal Infections

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01524432
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : April 2, 2013
Dr. Cheung Hing Cheong Private Dermatology Clinic
Information provided by (Responsible Party):
Prof. Yuen Chun-Wah, The Hong Kong Polytechnic University

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study in Hygienic Socks With Antifungal Agent-loaded Microcapsules for Patients With Tinea Pedis
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. • 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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01524432

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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
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Principal Investigator: Chun Wah M. Yuen Hong Kong PU

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Responsible Party: Prof. Yuen Chun-Wah, Professor, The Hong Kong Polytechnic University Identifier: NCT01524432    
Other Study ID Numbers: Mic_Clo_Terb
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: April 2, 2013
Last Verified: March 2013
Keywords provided by Prof. Yuen Chun-Wah, The Hong Kong Polytechnic University:
Additional relevant MeSH terms:
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Skin Diseases, Infectious
Tinea Pedis
Skin Diseases
Foot Dermatoses
Foot Diseases
Skin Manifestations
Signs and Symptoms
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors