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NCT04883593 Clinical Trial

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

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04883593
Other study ID # TA103-2004
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date September 3, 2020
Est. completion date February 20, 2021

Study information
Verified date May 2021
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date February 20, 2021
Est. primary completion date February 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
United States Catawba Research, LLC Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of subjects with complete cure at Week 6 (+/- 4 days) following treatment (study day 38-46) To evaluate safety and efficacy of TA103 Baseline to Week 6 Visit
See also
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Completed NCT03897257 - A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis Phase 2
Completed NCT03129321 - Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis Phase 3
Completed NCT02335255 - Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Phase 1
Withdrawn NCT02606383 - Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis Phase 3