Back to resultsSINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS
Primary Purpose
Tinea Pedis
Status
Unknown status
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
TERBINAFINE HYDROCHLORIDE (1%)
BUTENAFINE HYDROCHLORIDE (1%)
Vehicle Control
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Pedis
Eligibility Criteria
Inclusion Criteria:
- Male or nonpregnant females aged 18-60 years old.
- Clinical diagnosis of tinea pedis (total sign/symptom score >2), lesions between the toes, with possible extension to the lateral surfaces and soles of the feet confirmed by a positive microscopy prior to dosing.
- Willing to sign the informed consent.
Exclusion Criteria:
- Females who are pregnant (confirmed by a pregnancy test), suspect themselves to be pregnant (even if pregnancy test is negative), breast-feeding, or planning a pregnancy.
- Signs of systemic or other superficial fungal disease (e.g.onychomycosis), clinically relevant abnormal findings upon physical examination of the foot or previous treatment with a disallowed medication (such as corticosteroids).
- Presence of non-healing wounds and/or bacterial infection on the feet.
- Secondary bacterial infection due to tinea pedis
- Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
- History of hypersensitivity to any component of the test products.
- Current imuunosuppression. Specifically, these include patients with co-morbidities such as diabetes, HIV, chronic diseases requiring maintenance medications, acute febrile/infectious illnesses (i.e. Dengue, pneumonia, etc)
- Use within 3 months prior to baseline of: 1.) chemotherapy, or 2.) radiation therapy
Sites / Locations
- Clinical Trial Management and Testing Associates, Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment # 1
Treatment # 2
Placebo Control
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants with effective treatment at week 6
Defined as negative microscopy and improvement in signs and symptoms: mild or no erythema, desquamation or pruritis (<=1), no vesiculation, and a total sign/symptom score of <=2.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03999437
Brief Title
SINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS
Official Title
EFFICACY AND SAFETY OF A SINGLE-APPLICATION TREATMENT USING TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION TREATMENT USING BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
December 13, 2019 (Anticipated)
Study Completion Date
January 3, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Laboratories
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Tinea pedis or athlete's foot is the most common fungal infection worldwide, caused by infection of the feet with dermatophytes such as Trichophyton rubrum, Trichophyton interdigitale (formerly Trichophyton mentagrophytes), and Epidermophyton floccosum. Diagnosis of tinea pedia involves clinical symptoms as well as microscopic examination. Topical therapies are usually applied once or twice daily for as long as 4 weeks, posing a challenge to compliance. The current study aims to test a formulation of the single-dose 1% terbinafine hydrochloride, as well as a single-dose 1% butenafine hydrochloride, versus a vehicle control in adult Filipino patients with athlete's foot. This study will benefit the Filipino community by helping us determine which anti-fungal cream is most effective for athlete's foot.
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
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment # 1
Arm Type
Experimental
Arm Title
Treatment # 2
Arm Type
Experimental
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TERBINAFINE HYDROCHLORIDE (1%)
Intervention Description
Topical liquid solution
Intervention Type
Drug
Intervention Name(s)
BUTENAFINE HYDROCHLORIDE (1%)
Intervention Description
Topical liquid solution
Intervention Type
Drug
Intervention Name(s)
Vehicle Control
Intervention Description
Topical liquid solution
Primary Outcome Measure Information:
Title
Proportion of participants with effective treatment at week 6
Description
Defined as negative microscopy and improvement in signs and symptoms: mild or no erythema, desquamation or pruritis (<=1), no vesiculation, and a total sign/symptom score of <=2.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or nonpregnant females aged 18-60 years old.
Clinical diagnosis of tinea pedis (total sign/symptom score >2), lesions between the toes, with possible extension to the lateral surfaces and soles of the feet confirmed by a positive microscopy prior to dosing.
Willing to sign the informed consent.
Exclusion Criteria:
Females who are pregnant (confirmed by a pregnancy test), suspect themselves to be pregnant (even if pregnancy test is negative), breast-feeding, or planning a pregnancy.
Signs of systemic or other superficial fungal disease (e.g.onychomycosis), clinically relevant abnormal findings upon physical examination of the foot or previous treatment with a disallowed medication (such as corticosteroids).
Presence of non-healing wounds and/or bacterial infection on the feet.
Secondary bacterial infection due to tinea pedis
Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
History of hypersensitivity to any component of the test products.
Current imuunosuppression. Specifically, these include patients with co-morbidities such as diabetes, HIV, chronic diseases requiring maintenance medications, acute febrile/infectious illnesses (i.e. Dengue, pneumonia, etc)
Use within 3 months prior to baseline of: 1.) chemotherapy, or 2.) radiation therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliene Co, PhD
Phone
(632)8580001
Ext
8553
Email
julieneco@gmail.com
Facility Information:
Facility Name
Clinical Trial Management and Testing Associates, Inc.
City
Muntinlupa
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gertrude Chan, M.D.
Phone
(632) 659-3238
Email
clintrialtest@gmail.com
12. IPD Sharing Statement
Learn more about this trial
SINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS
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