Trial | NCT01118910  Report issue

Official Title

Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    15
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.
Intertrigo is an inflammatory condition of skin folds, induced or aggravated by heat, moisture, maceration, friction, or lack of air circulation. It is typically chronic with insidious onset of itching, burning, and stinging within the affected skin folds. Intertrigo frequently worsened or colonized by infection, which most commonly is candidal but also may be bacterial, fungal, or viral. The etiology of diaper dermatitis shows significant overlap with that of intertrigo. Vusion ointment, a highly effective treatment for diaper dermatitis, has been used by physicians for the treatment of intertrigo; however, there is a paucity of data in the literature regarding the use of Vusion ointment in this indication.

This study is the first to formally investigate the efficacy and safety of Vusion ointment for the treatment of intertrigo.
Study Started
Apr 30
2010
Primary Completion
Nov 30
2010
Study Completion
May 31
2011
Last Update
Aug 04
2011
Estimate

Drug Vusion

Vusion will be applied to areas of intertrigo

Vusion ointment Experimental

Criteria 

Inclusion Criteria:

Evidence of intertrigo

Exclusion Criteria:

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
No Results Posted