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

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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).

Key facts

Study ID

NCT01469767

Run by

Wake Forest University

People needed

10

Starts

2012-02-01

Expected to finish

2013-08-17

Last updated by the study team

2018-09-07

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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