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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04883593

Enrollment

160

Registered

2021-05-12

Start date

2020-09-03

Completion date

2021-02-20

Last updated

2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinea Pedis

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.

Interventions

DRUGTA103

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.

DRUGPlacebo Control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026