VANOS Cream and Skin Barrier Function

This study is currently recruiting participants.

Verified by Oregon Health and Science University, December 2008

Sponsors and Collaborators:	Oregon Health and Science University Medicis Pharmaceutical Corporation
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00819507

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 we 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 IV

Drug Information available for: Corticosteroids Fluocinonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Effects of a Novel Formulation of Fluocinonide 0.1% Cream on Skin Barrier Function in Atopic Dermatitis

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

Primary Outcome Measures:

Eczema Severity and Area Index [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Transepidermal water loss [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	January 2009
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vanos Cream: Experimental glucocorticoid cream	Drug: Fluocinonide Fluocinonide 0.1% cream topical daily for two weeks

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819507

Contacts

Contact: Maureen Keene

503-228-7350

Locations

United States, Oregon
Oregon Health & Science University Department of Dermatology	Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Eric L Simpson, MD

Sponsors and Collaborators

Oregon Health and Science University

Medicis Pharmaceutical Corporation

More Information

Responsible Party:	Oregon Health & Science university ( Eric Simpson, MD )
Study ID Numbers:	4590
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819507
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Skin barrier
Atopic Dermatitis
Corticosteroid
Effects on skin severity and barrier function

Study placed in the following topic categories:

Hypersensitivity
Fluocinonide
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Allergic Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009