Status:
COMPLETED
A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Tinea Pedis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04883593
Start Date
September 3 2020
End Date
February 20 2021
Last Update
May 12 2021
Active Locations (1)
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1
Catawba Research, LLC
Charlotte, North Carolina, United States, 28217