VANOS Cream and Skin Barrier Function

NCT ID: NCT00819507

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-06-21

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vanos Cream

glucocorticoid cream

Group Type: EXPERIMENTAL

Fluocinonide

Intervention Type: DRUG

Fluocinonide 0.1% cream topical daily for two weeks

Interventions

Fluocinonide

Fluocinonide 0.1% cream topical daily for two weeks

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicis Pharmaceutical Corporation

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Eric Simpson

Professor, Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University Department of Dermatology

Portland, Oregon, United States

Countries

United States

Other Identifiers

4590

Identifier Type: -

Identifier Source: org_study_id