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VANOS Cream and Skin Barrier Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00819507
First Posted: January 9, 2009
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Eric Simpson, Oregon Health and Science University
  Purpose
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.

Condition Intervention Phase
Atopic Dermatitis Drug: Fluocinonide Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Novel Formulation of Fluocinonide 0.1% Cream on Skin Barrier Function in Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Eric Simpson, Oregon Health and Science University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Change in Transepidermal Water Loss [ Time Frame: 2 weeks ]
    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).


Enrollment: 25
Study Start Date: January 2009
Study Completion Date: June 21, 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vanos Cream
glucocorticoid cream
Drug: Fluocinonide
Fluocinonide 0.1% cream topical daily for two weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819507


Locations
United States, Oregon
Oregon Health & Science University Department of Dermatology
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Medicis Pharmaceutical Corporation
  More Information

Responsible Party: Eric Simpson, Professor, Dermatology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00819507     History of Changes
Other Study ID Numbers: 4590
First Submitted: January 8, 2009
First Posted: January 9, 2009
Results First Submitted: May 17, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017

Keywords provided by Eric Simpson, Oregon Health and Science University:
Skin barrier
Atopic Dermatitis
Corticosteroid
Effects on skin severity and barrier function

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluocinonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents