Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis
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
1 other identifier
interventional
604
5 countries
24
Brief Summary
The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2011
Shorter than P25 for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 3, 2011
CompletedFirst Posted
Study publicly available on registry
May 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJanuary 23, 2013
January 1, 2013
1.3 years
May 3, 2011
January 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects with Adverse Events
To examine the long-term safety of treating tinea pedis, tinea corporis or tinea cruris, treatment-emergent adverse events occurring during the study will be recorded. Adverse events will be summarized by the number of subjects reporting events, system organ class, preferred term, severity, relationship to study drug, and seriousness. Baseline and end of study laboratory assessments will be conducted.
One Year
Secondary Outcomes (1)
Clinical Cure and Mycological Cure
1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment
Study Arms (1)
Safety Population
EXPERIMENTALInterventions
Daily dosing for 2 weeks each recurrence for patients with tinea pedis and Daily dosing for 1 week each recurrence for patients with tinea cruris and tinea corporis
Eligibility Criteria
You may qualify if:
- Evidence of tinea cruris, tinea pedis, or tinea corporis. Additional criteria listed in protocol
You may not qualify if:
- Pregnancy and allergies. Additional criteria listed in protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Fremont, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Miramar, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Warren, Michigan, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Paramus, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Hershey, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Goodletsville, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
College Station, Texas, United States
Unknown Facility
Plano, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Lynchburg, Virginia, United States
Unknown Facility
Belize City, Belize District, Belize
Unknown Facility
San Salvador, El Salvador
Unknown Facility
San Pedro, Sula, Honduras
Unknown Facility
Cidra, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2011
First Posted
May 9, 2011
Study Start
May 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
January 23, 2013
Record last verified: 2013-01