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

Image Dermatology P.C.

Status and phase

Completed

Early Phase 1

Conditions

Intertrigo

Treatments

Drug: Vusion

Study type

Interventional

Funder types

Other

Identifiers

NCT01118910

W0319-501

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

12 to 75 years old

Volunteers

Accepts Healthy Volunteers

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