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

• Status: Completed
• Trial end date: 2013-08-17
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University; Wake Forest University Health Sciences need to be deleted
• Collaborator: Medicis Pharmaceutical Corporation
• Treatments: Fluocinonide

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