VANOS Cream and Skin Barrier Function



Status:Recruiting
Conditions:Psoriasis, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:4/2/2016
Start Date:January 2009
Contact:Maureen Keene
Phone:503-228-7350

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

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.


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).
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