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

NCT ID: NCT04883593

Last Updated: 2021-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-03

Study Completion Date

2021-02-20

Brief Summary

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

Detailed Description

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A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing TA103 and the placebo control in the treatment of tinea pedis.

Conditions

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Tinea Pedis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

TA103

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Test Product Vehicle

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zaidoon A. Al-Zubaidy

Role: STUDY_DIRECTOR

Catawba Research

Locations

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Catawba Research, LLC

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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TA103-2004

Identifier Type: -

Identifier Source: org_study_id

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