Topical Antifungal Treatment for Tinea Cruris
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Cruris
1 other identifier
interventional
483
5 countries
21
Brief Summary
To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2011
Shorter than P25 for phase_3
21 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
First Submitted
Initial submission to the registry
April 25, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedAugust 28, 2013
August 1, 2013
10 months
April 25, 2011
August 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients achieving complete clearance
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture
3 weeks post-treatment
Secondary Outcomes (1)
Proportion of patients achieving effective treatment
1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment
Study Arms (2)
Active
EXPERIMENTALProduct 33525
Placebo
EXPERIMENTALProduct 33525 Placebo
Interventions
Eligibility Criteria
You may qualify if:
- moderate erythema, mild scaling, and moderate pruritis
You may not qualify if:
- pregnancy and allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
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
Evansville, Indiana, United States
Unknown Facility
Warren, Michigan, United States
Unknown Facility
Paramus, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Cincinnati, Ohio, 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
Unknown Facility
San Salvador, El Salvador
Unknown Facility
San Pedro Sula, Honduras
Unknown Facility
Cidra, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ron Staugaard
Medicis Pharmaceutical
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2011
First Posted
April 27, 2011
Study Start
May 1, 2011
Primary Completion
March 1, 2012
Study Completion
May 1, 2012
Last Updated
August 28, 2013
Record last verified: 2013-08