Back to resultsA Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.
Primary Purpose
Tinea Pedis
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
TA103
Placebo Control
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Pedis
Eligibility Criteria
Inclusion Criteria:
- Healthy male or non pregnant female aged ≥ 18 years
- Subjects must have provided IRB approved written informed consent
- Subjects must have clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
Exclusion Criteria:
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- Subjects with a history of hypersensitivity or allergy to any of the study medication ingredients and its excipients.
- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
Sites / Locations
- Catawba Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TA103
Placebo Control
Arm Description
The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.
The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.
Outcomes
Primary Outcome Measures
The proportion of subjects with complete cure at Week 6 (+/- 4 days) following treatment (study day 38-46)
To evaluate safety and efficacy of TA103
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04883593
Brief Title
A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.
Official Title
A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TA103 and Placebo Control in the Treatment of Tinea Pedis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
February 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate and compare the safety and efficacy of TA103 in the treatment of tinea pedis.
Detailed Description
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing TA103 and the placebo control in the treatment of tinea pedis.
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
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TA103
Arm Type
Experimental
Arm Description
The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.
Intervention Type
Drug
Intervention Name(s)
TA103
Other Intervention Name(s)
Test Product
Intervention Description
The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.
Intervention Type
Drug
Intervention Name(s)
Placebo Control
Other Intervention Name(s)
Vehicle
Intervention Description
The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.
Primary Outcome Measure Information:
Title
The proportion of subjects with complete cure at Week 6 (+/- 4 days) following treatment (study day 38-46)
Description
To evaluate safety and efficacy of TA103
Time Frame
Baseline to Week 6 Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or non pregnant female aged ≥ 18 years
Subjects must have provided IRB approved written informed consent
Subjects must have clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
Exclusion Criteria:
Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
Subjects with a history of hypersensitivity or allergy to any of the study medication ingredients and its excipients.
Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaidoon A. Al-Zubaidy
Organizational Affiliation
Catawba Research
Official's Role
Study Director
Facility Information:
Facility Name
Catawba Research, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28217
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.
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