A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.
NCT ID: NCT04883593
Last Updated: 2021-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
160 participants
INTERVENTIONAL
2020-09-03
2021-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Sun Pharmaceutical Industries, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Zaidoon A. Al-Zubaidy
Role: STUDY_DIRECTOR
Catawba Research
Locations
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Catawba Research, LLC
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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TA103-2004
Identifier Type: -
Identifier Source: org_study_id
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