Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01349998 |
Date of registration:
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03/05/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis
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Scientific title:
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An Open-Label Study to Evaluate the Safety of Long-Term Administration of Product 33525 in Subjects With Tinea Pedis, Tinea Corporis, or Tinea Cruris |
Date of first enrolment:
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May 2011 |
Target sample size:
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604 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01349998 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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Phase 3
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Countries of recruitment
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Belize
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El Salvador
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Honduras
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Puerto Rico
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Evidence of tinea cruris, tinea pedis, or tinea corporis. Additional criteria listed
in protocol
Exclusion Criteria:
- Pregnancy and allergies. Additional criteria listed in protocol
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tinea Cruris
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Tinea Corporis
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Tinea Pedis
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Intervention(s)
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Drug: Product 33525
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Primary Outcome(s)
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Number of Subjects with Adverse Events
[Time Frame: One Year]
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Secondary Outcome(s)
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Clinical Cure and Mycological Cure
[Time Frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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