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Safety and Efficacy of a Novel Topical Therapy for Tinea Pedis (Athlete's Foot)

Primary Purpose

Tinea Pedis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Topical therapy
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Pedis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Otherwise healthy patients with laboratory proven tinea pedis

Exclusion Criteria:

  • Age lower than 18 and higher than 80

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm Description

Patients with tinea pedis

Outcomes

Primary Outcome Measures

Cure of tinea pedis

Secondary Outcome Measures

Full Information

First Posted
August 28, 2008
Last Updated
February 23, 2009
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00848666
Brief Title
Safety and Efficacy of a Novel Topical Therapy for Tinea Pedis (Athlete's Foot)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a novel topical therapy in patients with laboratory confirmed tinea pedis. During the follow-up period clinical and mycological examinations will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Patients with tinea pedis
Intervention Type
Drug
Intervention Name(s)
Topical therapy
Intervention Description
One time immersion of the feet in a liquid containing water, alcohol, vinegar, benzoic acid and salicylic acid for a total of 30 minutes.
Primary Outcome Measure Information:
Title
Cure of tinea pedis
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Otherwise healthy patients with laboratory proven tinea pedis Exclusion Criteria: Age lower than 18 and higher than 80
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kahana
Phone
972-4-6304667
Email
kahanam@hy.health.gov.il
First Name & Middle Initial & Last Name & Degree
Michael Kahana, MD

12. IPD Sharing Statement

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Safety and Efficacy of a Novel Topical Therapy for Tinea Pedis (Athlete's Foot)

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