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OpenTrials
Completed

NCT Number: NCT01118910

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

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.

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Key information

Conditions

Intertrigo Dermatitis Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Image Dermatology P.C.

Montclair, New Jersey, 07042, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vusion

Drug

Vusion will be applied to areas of intertrigo

Primary outcomes

  1. The number of patients for whom Vusion effectively treated intertrigo

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Image Dermatology P.C.

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 7, 2010
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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