VANOS Cream and Skin Barrier Function

• ClinicalTrials.gov Identifier: NCT00819507
• Recruitment Status: Completed
• First Posted: January 9, 2009
• Results First Posted: July 11, 2017
• Last Update Posted: July 11, 2017
• Sponsor: Oregon Health and Science University
• Collaborator: Medicis Pharmaceutical Corporation
• Information provided by (Responsible Party): Eric Simpson, Oregon Health and Science University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Fluocinonide	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: N/A
• 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
• Study Start Date: January 2009
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: June 21, 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vanos Cream; glucocorticoid cream	Drug: Fluocinonide; Fluocinonide 0.1% cream topical daily for two weeks

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 4590
• First Posted: January 9, 2009
• 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, Atopic; Dermatitis; 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