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

Early Phase 1

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Placebo Control; Drug: TA103

• Registration Number: NCT04883593
• Lead Sponsor: Taro Pharmaceuticals USA

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.

Study Timeline

• Study Start: 2020-09-03
• Primary Completion: 2021-02-20
• Study Completion: 2021-02-20
• Status Verified: 2021-05
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Study First Posted: 2021-05-12
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control	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.
TA103	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Catawba Research, LLC; 🇺🇸 Charlotte, North Carolina, United States