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Completed

NCT Number: NCT04883593

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

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

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Key information

Conditions

Tinea Pedis Bacterial Infections and Mycoses Dermatomycoses Foot Dermatoses Foot Diseases Infections Mycoses Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Catawba Research, LLC

Charlotte, North Carolina, 28217, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TA103

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.

Other names: Test Product

Placebo Control

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.

Other names: Vehicle

Primary outcomes

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

    Time frame: Baseline to Week 6 Visit

    To evaluate safety and efficacy of TA103

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TA103 and Placebo Control in the Treatment of Tinea Pedis.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 12, 2021
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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