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

NCT ID: NCT01118910

Last Updated: 2011-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-05-31

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.

Conditions

Intertrigo

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vusion ointment

Group Type: EXPERIMENTAL

Vusion

Intervention Type: DRUG

Vusion will be applied to areas of intertrigo

Interventions

Vusion

Vusion will be applied to areas of intertrigo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Image Dermatology P.C.

OTHER

Sponsor Role: lead

Responsible Party

Image Dermatology P.C.

Principal Investigators

Jeanine B. Downie, M.D.

Role: PRINCIPAL_INVESTIGATOR

Image Dermatology P.C.

Locations

Image Dermatology P.C.

Montclair, New Jersey, United States

Countries

United States

Other Identifiers

W0319-501

Identifier Type: -

Identifier Source: org_study_id