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

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ClinicalTrials.gov Identifier: NCT01469767
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : May 1, 2017
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date  ICMJE November 7, 2011
First Posted Date  ICMJE November 10, 2011
Results First Submitted Date  ICMJE January 27, 2017
Results First Posted Date  ICMJE May 1, 2017
Last Update Posted Date September 7, 2018
Actual Study Start Date  ICMJE February 1, 2012
Actual Primary Completion Date August 17, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
IGA [ Time Frame: 14 days ]
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2011)
Change in Investigator's Global Assessment of atopic dermatitis [ Time Frame: Baseline to 14 days ]
Change History Complete list of historical versions of study NCT01469767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
  • Actigraphy [ Time Frame: 14 days ]
    Actigraphy Movement Count per Hour:Subjects will be asked to wear an actigraphy monitor on each wrist for the duration of the 14-day study. These monitors appear and function similarly to a wristwatch. The actigraph provides a continuous measure of wrist activity and may be used to quantify nocturnal scratching behavior. A piezoelectric accelerometer records the integration of intensity, amount, and duration of stimuli in all 3 dimensions of wrist movement. Measurements are taken at 32 Hz and a summation value is recorded at the end of each 30-second epoch. The number of 30-second epochs with movement (in which acceleration was detected irrespective of the magnitude of the acceleration) is recorded and summed to give a movement score. This is divided by the duration of time in bed to produce a movement count per hour, which is a sensitive quantitative measure of scratch-associated activity.
  • EASI [ Time Frame: 14 days ]
    Eczema Area and Severity Index Score:Disease severity will be assessed with the Eczema Area and Severity Index (EASI).This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions and scores erythema, excoriation, induration/papulation, and lichenification. The total are summed for one total EASI score. .The total scores range from 0 (no Eczema) -72 (most severe Eczema)."
  • BSA [ Time Frame: 14 days ]
    Body Surface Area of atopic dermatitis. The BSA is measured as the total percent of the entire body with atopic dermatitis involved, so the scores range from 0% to 100% of total body involvement.
  • VAS [ Time Frame: 14 days ]
    Visual Analog Scale for itch: A 100 millimeter (mm) Visual Analog Scale (VAS) will be used to measure itch intensity. VAS is a self-report tool that is designed to present to the respondent a rating scale with minimum constraints. VAS data is recorded as the number of mm from the left of the line with the range 0-100 mm. The Visual Analog Scale is anchored with the verbal descriptions of "no itch" on the left and "the most intense itch imaginable" on the right.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2011)
  • Change in Actigraphy Movement Count per Hour [ Time Frame: Baseline to 14 days ]
  • Change in Eczema Area and Severity Index Score [ Time Frame: Baseline to 14 days ]
  • Change in Body Surface Area of atopic dermatitis [ Time Frame: Baseline to 14 days ]
  • Change in Visual Analog Scale for itch [ Time Frame: Baseline to 14 days ]
  • Subject Global Assessment of atopic dermatitis [ Time Frame: 14 days ]
  • Adherence to Fluocinonide Cream [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
Official Title  ICMJE Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE Drug: Fluocinonide cream
Fluocinonide cream 0.1% applied twice daily for 5 days.
Other Name: Vanos
Study Arms  ICMJE Experimental: Fluocinonide cream
Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Intervention: Drug: Fluocinonide cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2011)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 17, 2013
Actual Primary Completion Date August 17, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01469767
Other Study ID Numbers  ICMJE IRB00018876
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor  ICMJE Wake Forest University
Collaborators  ICMJE Medicis Pharmaceutical Corporation
Investigators  ICMJE
Principal Investigator: Steven R Feldman, MD, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP