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VANOS Cream and Skin Barrier Function

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atopic Dermatitis

Intervention: Fluocinonide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Oregon Health and Science University

Overall contact:
Maureen Keene, Phone: 503-228-7350

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.

Clinical Details

Official title: Effects of a Novel Formulation of Fluocinonide 0.1% Cream on Skin Barrier Function in Atopic Dermatitis

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Eczema Severity and Area Index

Secondary outcome: Transepidermal water loss

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Maureen Keene, Phone: 503-228-7350

Oregon Health & Science University Department of Dermatology, Portland, Oregon 97239, United States; Recruiting
Eric L Simpson, MD, Principal Investigator
Additional Information

Starting date: January 2009
Last updated: August 11, 2009

Page last updated: August 23, 2015

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