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

Early Phase 1

Completed

• Conditions: Intertrigo
• Interventions: Drug: Vusion

• Registration Number: NCT01118910
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Primary Completion: 2010-11
• Study Completion: 2011-05
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vusion ointment	Vusion	-

Primary Outcome Measures

Name	Time	Method
The number of patients for whom Vusion effectively treated intertrigo	3 months

Trial Locations

Locations (1)

Image Dermatology P.C.; 🇺🇸 Montclair, New Jersey, United States