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

This study has been completed.
Sponsor:
Information provided by:
Image Dermatology P.C.
ClinicalTrials.gov Identifier:
NCT01118910
First received: May 6, 2010
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Intertrigo
Drug: Vusion
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo

Further study details as provided by Image Dermatology P.C.:

Primary Outcome Measures:
  • The number of patients for whom Vusion effectively treated intertrigo [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: April 2010
Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vusion ointment Drug: Vusion
Vusion will be applied to areas of intertrigo

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.

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118910

Locations
United States, New Jersey
Image Dermatology P.C.
Montclair, New Jersey, United States, 07042
Sponsors and Collaborators
Image Dermatology P.C.
Investigators
Principal Investigator: Jeanine B. Downie, M.D. Image Dermatology P.C.
  More Information

No publications provided

Responsible Party: Jeanine B. Downie, M.D., Image Dermatology P.C.
ClinicalTrials.gov Identifier: NCT01118910     History of Changes
Other Study ID Numbers: W0319-501
Study First Received: May 6, 2010
Last Updated: August 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Image Dermatology P.C.:
Intertrigo
Vusion

Additional relevant MeSH terms:
Intertrigo
Dermatitis
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on November 27, 2014