Status:
COMPLETED
Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
Lead Sponsor:
Wake Forest University
Collaborating Sponsors:
Medicis Pharmaceutical Corporation
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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).
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01469767
Start Date
February 1 2012
End Date
August 17 2013
Last Update
September 7 2018
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157