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VANOS Cream and Skin Barrier Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00819507
First received: January 8, 2009
Last updated: August 11, 2009
Last verified: August 2009
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Steroids
U.S. FDA Resources

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
Experimental: Vanos Cream
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

No publications provided

Responsible Party: Eric Simpson, MD, Oregon Health & Science university
ClinicalTrials.gov Identifier: NCT00819507     History of Changes
Other Study ID Numbers: 4590
Study First Received: January 8, 2009
Last Updated: August 11, 2009
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

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

ClinicalTrials.gov processed this record on May 22, 2013