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A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis (Vanos)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluocinonide Cream 0.1%
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Open-Label, Topical, Cream, Eczema, Vanos

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (and assent if applicable)
  • Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 - 4 in the Investigator Global Assessment (Appendix B))
  • Percentage of overall body surface are of involvement (BSA) must be ≥2%
  • Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control

Exclusion Criteria:

  • Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids
  • Application or use within 2 weeks of baseline of 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
  • 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 and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fluocinonide Cream 0.1%

Arm Description

Fluocinonide Cream 0.1% open label

Outcomes

Primary Outcome Measures

Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.
Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.

Secondary Outcome Measures

Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.
Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.

Full Information

First Posted
January 12, 2010
Last Updated
July 3, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
Medicis Pharmaceutical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01049243
Brief Title
A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis
Acronym
Vanos
Official Title
An Open-Label Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Medicis Pharmaceutical Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days.
Detailed Description
This is a single center study. This is an open label study of fluocinonide cream 0.1% (Vanos™) for subjects with mild to severe atopic dermatitis with an assessment of 2 to 4 on the Investigator Global Assessment scale (Appendix B). Up to 20 subjects age 12 and above will be enrolled after providing informed consent. All subjects will receive the study medication, fluocinonide cream 0.1% (Vanos™). Each subject will be instructed to use fluocinonide cream 0.1% (Vanos™) twice daily for three consecutive days (for a total of 6 doses). The study period will last for approximately 2 weeks. Subjects will be evaluated at baseline and Day 2 or 3 (as needed to achieve 6 doses), day 7 and day 14 (or end of study). Subjects will not apply any study drug after the 6 doses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Open-Label, Topical, Cream, Eczema, Vanos

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluocinonide Cream 0.1%
Arm Type
Other
Arm Description
Fluocinonide Cream 0.1% open label
Intervention Type
Drug
Intervention Name(s)
Fluocinonide Cream 0.1%
Other Intervention Name(s)
Vanos
Intervention Description
0.1% Cream, One Application, Twice Daily, 14 Days
Primary Outcome Measure Information:
Title
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.
Description
Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.
Time Frame
Baseline to 3 days
Secondary Outcome Measure Information:
Title
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.
Description
Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.
Time Frame
Baseline to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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 (and assent if applicable) Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 - 4 in the Investigator Global Assessment (Appendix B)) Percentage of overall body surface are of involvement (BSA) must be ≥2% Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control Exclusion Criteria: Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids Application or use within 2 weeks of baseline of 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 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 and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis

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