Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
Information source: Wake Forest University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: Fluocinonide cream (Drug)
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
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.
- 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
- 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 â¥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.
- Use within four weeks from Baseline any systemic antiâinflammatory medication, which
may influence study outcome, such as systemic corticosteroids.
- Application or use within two weeks of Baseline topical corticosteroid medications or
topical antiâinflammatory 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
- Amount of disease involvement that would require >60 gm of cream in a 1 week period.
- Subjects with known allergy or sensitivity to topical VanosÂ® cream or components.
- Pregnant women
- Women who are breastfeeding
Locations and Contacts
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
Susie Dowd, Phone: 336-716-3775, Email: email@example.com
Adele Clark, PA-C, Phone: 336-716-7465, Email: firstname.lastname@example.org
Steven R Feldman, MD, PhD, Principal Investigator
Starting date: November 2011
Last updated: June 27, 2012