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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01118910

Enrollment

Registered

2010-05-07

Start date

2010-04-30

Completion date

2011-05-31

Last updated

2011-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intertrigo

Keywords

Intertrigo, Vusion

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.

Interventions

DRUGVusion

Vusion will be applied to areas of intertrigo

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
The number of patients for whom Vusion effectively treated intertrigo	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026