VANOS Cream and Skin Barrier Function

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00819507
• Other study ID #: 4590
• Status: Recruiting
• Phase: Phase 4
• First received: January 8, 2009
• Last updated: August 11, 2009
• Start date: January 2009

Study information

• Verified date: August 2009
• Source: Oregon Health and Science University
• Contact: Maureen Keene
• Phone: 503-228-7350
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Fluocinonide
Fluocinonide 0.1% cream topical daily for two weeks

Locations

Country	Name	City	State
United States	Oregon Health & Science University Department of Dermatology	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Medicis Pharmaceutical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eczema Severity and Area Index		2 Weeks	No
Secondary	Transepidermal water loss		2 weeks	No