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VANOS Cream and Skin Barrier Function

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluocinonide
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Skin barrier, Atopic Dermatitis, Corticosteroid, Effects on skin severity and barrier function

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of AD according to Hanifin-Rajka criteria (see Appendix B)
  • Age 12 years or older
  • Must have an Investigator's Global Assessment (IGA) Score of Moderate, Severe, or Very Severe (See Appendix C)
  • Must have failed to achieve adequate disease despite adequate topical or systemic therapy
  • Must be a candidate, according to the principal investigator and standard of care, for a super-potent topical steroid course. Subjects that are candidates for super-potent topical steroids are defined as subjects whose disease is not adequately controlled with medium-potency topical steroids or systemic therapy, including phototherapy.

Exclusion Criteria:

  • Active skin infection
  • Hypersensitivity to any ingredients in Vanos cream
  • Previous use of super-potent topical steroids within 2 weeks of starting study (Class I steroid).

Sites / Locations

  • Oregon Health & Science University Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vanos Cream

Arm Description

glucocorticoid cream

Outcomes

Primary Outcome Measures

Change in Eczema Severity and Area Index
The eczema area and severity index (EAS I) is a validated composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and end of study (baseline EASI subtracted from end of study EASI) was calculated as a final outcome data point.

Secondary Outcome Measures

Change in Transepidermal Water Loss
A measure of water flux out the skin using a small non-invasive probe. Values can range between 0-no water loss and over 100-severe water loss. This measure indicates the degree of skin barrier permeability with lower values indicating lower permeability (improved skin barrier function).

Full Information

First Posted
January 8, 2009
Last Updated
June 9, 2017
Sponsor
Oregon Health and Science University
Collaborators
Medicis Pharmaceutical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00819507
Brief Title
VANOS Cream and Skin Barrier Function
Official Title
Effects of a Novel Formulation of Fluocinonide 0.1% Cream on Skin Barrier Function in Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
June 21, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Medicis Pharmaceutical Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of short-term therapy using "VANOS Cream," a super-potent topical steroid cream on skin barrier function in patients with atopic dermatitis. This cream is already approved for this indication, but the investigators will further examine its effects on the skin barrier. This cream is a novel formulation of fluocinonide designed to enhance compliance with a cream base, but have the skin barrier repair properties of an ointment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Skin barrier, Atopic Dermatitis, Corticosteroid, Effects on skin severity and barrier function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vanos Cream
Arm Type
Experimental
Arm Description
glucocorticoid cream
Intervention Type
Drug
Intervention Name(s)
Fluocinonide
Intervention Description
Fluocinonide 0.1% cream topical daily for two weeks
Primary Outcome Measure Information:
Title
Change in Eczema Severity and Area Index
Description
The eczema area and severity index (EAS I) is a validated composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and end of study (baseline EASI subtracted from end of study EASI) was calculated as a final outcome data point.
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Change in Transepidermal Water Loss
Description
A measure of water flux out the skin using a small non-invasive probe. Values can range between 0-no water loss and over 100-severe water loss. This measure indicates the degree of skin barrier permeability with lower values indicating lower permeability (improved skin barrier function).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of AD according to Hanifin-Rajka criteria (see Appendix B) Age 12 years or older Must have an Investigator's Global Assessment (IGA) Score of Moderate, Severe, or Very Severe (See Appendix C) Must have failed to achieve adequate disease despite adequate topical or systemic therapy Must be a candidate, according to the principal investigator and standard of care, for a super-potent topical steroid course. Subjects that are candidates for super-potent topical steroids are defined as subjects whose disease is not adequately controlled with medium-potency topical steroids or systemic therapy, including phototherapy. Exclusion Criteria: Active skin infection Hypersensitivity to any ingredients in Vanos cream Previous use of super-potent topical steroids within 2 weeks of starting study (Class I steroid).
Facility Information:
Facility Name
Oregon Health & Science University Department of Dermatology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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VANOS Cream and Skin Barrier Function

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