Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo|
- The number of patients for whom Vusion effectively treated intertrigo [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
|Experimental: Vusion ointment||
Vusion will be applied to areas of intertrigo
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.
|United States, New Jersey|
|Image Dermatology P.C.|
|Montclair, New Jersey, United States, 07042|
|Principal Investigator:||Jeanine B. Downie, M.D.||Image Dermatology P.C.|