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

The purpose of this study is to assess the efficacy 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
and Visual Analog Scale for itch. The investigators hypothesize that each of these measures
will be improved at Day 7 and Day 14 compared to Baseline.

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