- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00819507
VANOS Cream and Skin Barrier Function
June 9, 2017 updated by: Eric Simpson, Oregon Health and Science University
Effects of a Novel Formulation of Fluocinonide 0.1% Cream on Skin Barrier Function in Atopic Dermatitis
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University Department of Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vanos Cream
glucocorticoid cream
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Fluocinonide 0.1% cream topical daily for two weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Eczema Severity and Area Index
Time Frame: 2 Weeks
|
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.
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2 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Transepidermal Water Loss
Time Frame: 2 weeks
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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).
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
June 21, 2010
Study Registration Dates
First Submitted
January 8, 2009
First Submitted That Met QC Criteria
January 8, 2009
First Posted (Estimate)
January 9, 2009
Study Record Updates
Last Update Posted (Actual)
July 11, 2017
Last Update Submitted That Met QC Criteria
June 9, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Eczema
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Allergic Agents
- Fluocinonide
Other Study ID Numbers
- 4590
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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