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A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.

Sponsor
Taro Pharmaceuticals USA (Industry)
Overall Status
Completed
CT.gov ID
NCT04883593
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
5.6
Actual Duration (Months)
28.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate and compare the safety and efficacy of TA103 in the treatment of tinea pedis.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TA103 and Placebo Control in the Treatment of Tinea Pedis.
Actual Study Start Date :
Sep 3, 2020
Actual Primary Completion Date :
Feb 20, 2021
Actual Study Completion Date :
Feb 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: TA103

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.

Drug: TA103
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.
Other Names:
  • Test Product

    		•
    Placebo Comparator: Placebo Control

    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.

    Drug: Placebo Control
    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.
    Other Names:
  • Vehicle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The proportion of subjects with complete cure at Week 6 (+/- 4 days) following treatment (study day 38-46) [Baseline to Week 6 Visit]

      To evaluate safety and efficacy of TA103

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Catawba Research, LLC Charlotte North Carolina United States 28217

    Sponsors and Collaborators

    • Taro Pharmaceuticals USA

    Investigators

    • Study Director: Zaidoon A. Al-Zubaidy, Catawba Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taro Pharmaceuticals USA
    ClinicalTrials.gov Identifier:
    NCT04883593
    Other Study ID Numbers:
    • TA103-2004
    First Posted:
    May 12, 2021
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tinea
    Tinea Pedis

    Study Results

    No Results Posted as of May 12, 2021