VANOS Cream and Skin Barrier Function

Overview

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.

Full Title of Study: “Effects of a Novel Formulation of Fluocinonide 0.1% Cream on Skin Barrier Function in Atopic Dermatitis”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: January 2010

Interventions

• Drug: Fluocinonide
  • Fluocinonide 0.1% cream topical daily for two weeks

Arms, Groups and Cohorts

• Experimental: Vanos Cream
  • glucocorticoid cream

Clinical Trial Outcome Measures

Primary 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 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).

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Oregon Health and Science University
• Collaborator
  • Medicis Pharmaceutical Corporation
• Provider of Information About this Clinical Study
  • Principal Investigator: Eric Simpson, Professor, Dermatology – Oregon Health and Science University