VANOS Cream and Skin Barrier Function
Information source: Oregon Health and Science University
Information obtained from ClinicalTrials.gov on February 07, 2013
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
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