Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to determine if people with moist, red, patches on their skin in body folds would benefit treatment of those areas with an FDA-approved drug called Vusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Apr 2010
Shorter than P25 for early_phase_1
1 active site
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
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 6, 2010
CompletedFirst Posted
Study publicly available on registry
May 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedAugust 4, 2011
August 1, 2011
7 months
May 6, 2010
August 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of patients for whom Vusion effectively treated intertrigo
3 months
Study Arms (1)
Vusion ointment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Evidence of intertrigo
You may not qualify if:
- Pregnancy
- Use of systemic or topical antifungal or corticosteroid treatment in the previous 14 days or during the 3-month treatment period
- allergy of sensitivity to Vusion
- undergoing warfarin anticoagulation
- alcohol or drug abuse
- Investigator determines they cannot particpate
- history of non-compliance or poor cooperation
- participation in an investigaitonal drug study within 30 days of Baseline Visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Image Dermatology P.C.
Montclair, New Jersey, 07042, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeanine B. Downie, M.D.
Image Dermatology P.C.
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 6, 2010
First Posted
May 7, 2010
Study Start
April 1, 2010
Primary Completion
November 1, 2010
Study Completion
May 1, 2011
Last Updated
August 4, 2011
Record last verified: 2011-08