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

Intertrigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118910
• Other study ID #: W0319-501
• Status: Completed
• Phase: Early Phase 1
• First received: May 6, 2010
• Last updated: August 3, 2011
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: Image Dermatology P.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Intertrigo

Intervention

Drug:
• Vusion
Vusion will be applied to areas of intertrigo

Locations

Country	Name	City	State
United States	Image Dermatology P.C.	Montclair	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Image Dermatology P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients for whom Vusion effectively treated intertrigo		3 months