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

Primary Purpose

Intertrigo

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vusion
Sponsored by
Image Dermatology P.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intertrigo focused on measuring Intertrigo, Vusion

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Image Dermatology P.C.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vusion ointment

Arm Description

Outcomes

Primary Outcome Measures

The number of patients for whom Vusion effectively treated intertrigo

Secondary Outcome Measures

Full Information

First Posted
May 6, 2010
Last Updated
August 3, 2011
Sponsor
Image Dermatology P.C.
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1. Study Identification

Unique Protocol Identification Number
NCT01118910
Brief Title
Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
Official Title
Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Image Dermatology P.C.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intertrigo
Keywords
Intertrigo, Vusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vusion ointment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vusion
Intervention Description
Vusion will be applied to areas of intertrigo
Primary Outcome Measure Information:
Title
The number of patients for whom Vusion effectively treated intertrigo
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanine B. Downie, M.D.
Organizational Affiliation
Image Dermatology P.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Image Dermatology P.C.
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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