Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis

Condition(s) targeted: Atopic Dermatitis

Intervention: Fluocinonide cream (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Wake Forest University

Official(s) and/or principal investigator(s):
Steven R Feldman, MD, PhD, Principal Investigator, Affiliation: Wake Forest University

The purpose of this study is to assess the efficacy and tolerability of short-term treatment with fluocinonide cream 0. 1% (Vanos®) in the treatment of atopic dermatitis (AD). Our hypothesis is that subjects will have a reduction in Investigator's Global Assessment scores at Day 7 and Day 14 compared to Baseline.

Secondary objectives include the use of actigraphy monitoring to determine the ability of Vanos® cream to reduce itch, and thus nocturnal scratching, in AD. Our hypothesis is that subjects will have a reduction in nocturnal scratching activity, as measured by actigraphy movement count per hour, at Day 7 and Day 14 compared to Baseline. Other secondary outcome measures include Eczema Area and Severity Index (EASI) score, body surface area involvement, Visual Analog Scale for itch, and Subject Global Assessment. The investigators hypothesize that each of these measures will be improved at Day 7 and Day 14 compared to Baseline. Medication adherence will be determined using objective adherence monitors. The investigators also hypothesize that subjects will have improved adherence to a topical medication for AD, compared to published sources, if they are only required to use the medication for a short and defined duration.

Official title: Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis

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

Primary outcome: Change in Investigator's Global Assessment of atopic dermatitis

Secondary outcome:

Change in Actigraphy Movement Count per Hour

Change in Eczema Area and Severity Index Score

Change in Body Surface Area of atopic dermatitis

Change in Visual Analog Scale for itch

Subject Global Assessment of atopic dermatitis

Adherence to Fluocinonide Cream

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

Criteria:

Inclusion Criteria:

- Male or female with mild to severe atopic dermatitis, 12 years of age or older, that

agree to participate and provide written consent (parent permission and assent if applicable).

- Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA

rating of 2 through 4 in the Investigator Global Assessment).

- Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on

a 100-point scale.

- Percentage of overall body surface area of involvement (BSA) must be ≥2%.

- Women of childbearing potential will be allowed to participate in the study, and will

be required to use at least one form of birth control.

Exclusion Criteria:

- Use within four weeks from Baseline any systemic anti�inflammatory medication, which

may influence study outcome, such as systemic corticosteroids.

- Application or use within two weeks of Baseline topical corticosteroid medications or

topical anti�inflammatory medication, which may influence study outcome.

- Presence of a concurrent medical condition, which is determined by the investigator

to potentially interfere with study outcomes or patient assessments.

- Introduction of any other prescription medication, topical or systemic, for atopic

dermatitis while participating in the study.

- Use of anti-histamines while participating in the study will not be permitted unless

the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the subject must remain on a stable dose of anti-histamine throughout the study period. If a patient meets such criteria for anti-histamine use, this will be noted in the subject's chart.

- Amount of disease involvement that would require >60 gm of cream in a 1 week period.

- Subjects with known allergy or sensitivity to topical Vanos® cream or components.

- Pregnant women

- Women who are breastfeeding

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
Susie Dowd, Phone: 336-716-3775, Email: sdowd@wakehealth.edu
Adele Clark, PA-C, Phone: 336-716-7465, Email: adclark@wakehealth.edu
Steven R Feldman, MD, PhD, Principal Investigator

Starting date: November 2011
Last updated: June 27, 2012