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

NCT01524432 | Completed Phase 1 DMC

• 1 other identifier: Mic_Clo_Terb
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinea Pedis

Keywords

Clotrimazole; Microcapsules

Outcome Measures

Primary Outcomes (1)

• • 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.

  Day 44

Secondary Outcomes (1)

• Effective Treatment

  Day 44

Study Arms (2)

Drug loaded microcapsules socks

EXPERIMENTAL

Study medication

Drug: Anti-fungal agent (Clotrimazole) loaded microcapsules

No drug loaded microcapsules socks

PLACEBO COMPARATOR

Placebo medication

Drug: Placebo

Interventions

Anti-fungal agent (Clotrimazole) loaded microcapsules DRUG

Clotrimazole loaded microcapsules padded on socks and the patient should wear the socks every day for 2 weeks

Also known as: Anti-fungal agent loaded microcapsules

Drug loaded microcapsules socks

Placebo DRUG

No drug loaded microcapsules socks

No drug loaded microcapsules socks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Yuen Chun-Wah: lead
• Dr. Cheung Hing Cheong Private Dermatology Clinic: collaborator

Study Sites (1)

Institute of Textiles and Clothing, The Hong Kong Polytechnic University

Kowloon, 00852, Hong Kong

Location

MeSH Terms

Conditions

Tinea Pedis

Interventions

Clotrimazole

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chun Wah M. Yuen

  Hong Kong PU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: February 2, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 2, 2013

Record last verified: 2013-03

Locations

HK (1)