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
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Fluocinonide cream||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis|
|Actual Study Start Date :||February 1, 2012|
|Actual Primary Completion Date :||August 17, 2013|
|Actual Study Completion Date :||August 17, 2013|
Experimental: Fluocinonide cream
Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Drug: Fluocinonide cream
Fluocinonide cream 0.1% applied twice daily for 5 days.
Other Name: Vanos
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469767
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Steven R Feldman, MD, PhD||Wake Forest University Health Sciences|