VANOS Cream and Skin Barrier Function

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Fluocinonide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00819507

4590

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Vanos Cream

Experimental group

Description:

glucocorticoid cream

Treatment:

Drug: Fluocinonide