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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118910
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : August 4, 2011
Information provided by:
Image Dermatology P.C.

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.

Condition or disease Intervention/treatment Phase
Intertrigo Drug: Vusion Early Phase 1

Detailed Description:

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
Study Start Date : April 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: Vusion ointment Drug: Vusion
Vusion will be applied to areas of intertrigo

Primary Outcome Measures :
  1. The number of patients for whom Vusion effectively treated intertrigo [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01118910

United States, New Jersey
Image Dermatology P.C.
Montclair, New Jersey, United States, 07042
Sponsors and Collaborators
Image Dermatology P.C.
Principal Investigator: Jeanine B. Downie, M.D. Image Dermatology P.C.

Responsible Party: Jeanine B. Downie, M.D., Image Dermatology P.C. Identifier: NCT01118910     History of Changes
Other Study ID Numbers: W0319-501
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011

Keywords provided by Image Dermatology P.C.:

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Eczematous