VANOS Cream and Skin Barrier Function

NCT00819507 | Completed Phase 4 Results

• 1 other identifier: 4590
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Eczema Severity and Area Index

  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.

  2 Weeks

Secondary Outcomes (1)

• Change in Transepidermal Water Loss

  2 weeks

Study Arms (1)

Vanos Cream

EXPERIMENTAL

glucocorticoid cream

Drug: Fluocinonide

Interventions

Fluocinonide DRUG

Fluocinonide 0.1% cream topical daily for two weeks

Vanos Cream

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Medicis Pharmaceutical Corporation: collaborator

Study Sites (1)

Oregon Health & Science University Department of Dermatology

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Fluocinonide

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluocinolone Acetonide; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Eric Simpson
• Organization: Oregon Health & Science University

simpsone@ohsu.edu

503-494-2121

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dermatology

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 9, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: June 21, 2010
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06

Locations

US (1)