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

NCT ID: NCT01469767

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-01
• Study Completion Date: 2013-08-17

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 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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluocinonide cream

Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.

Group Type: EXPERIMENTAL

Fluocinonide cream

Intervention Type: DRUG

Fluocinonide cream 0.1% applied twice daily for 5 days.

Interventions

Fluocinonide cream

Fluocinonide cream 0.1% applied twice daily for 5 days.

Intervention Type: DRUG

Other Intervention Names

Vanos

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicis Pharmaceutical Corporation

INDUSTRY

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00018876

Identifier Type: -

Identifier Source: org_study_id