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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 )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Intervention Drug: Fluocinonide cream
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluocinonide Cream
Hide Arm/Group Description

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

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Fluocinonide Cream
Hide Arm/Group Description

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

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
3
  30.0%
Between 18 and 65 years
6
  60.0%
>=65 years
1
  10.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
7
  70.0%
Male
3
  30.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  40.0%
White
6
  60.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title IGA
Hide Description 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
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluocinonide Cream
Hide Arm/Group Description:

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

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: units on a scale
1
(1 to 3)
2.Secondary Outcome
Title Actigraphy
Hide Description 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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluocinonide Cream
Hide Arm/Group Description:

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

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Movement count per hour
85.7  (3.2)
3.Secondary Outcome
Title EASI
Hide Description 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)."
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluocinonide Cream
Hide Arm/Group Description:

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

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: units on a scale
2.2
(0.2 to 23.2)
4.Secondary Outcome
Title BSA
Hide Description 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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluocinonide Cream
Hide Arm/Group Description:

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

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: Percent BSA
5.5
(1 to 55)
5.Secondary Outcome
Title VAS
Hide Description 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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluocinonide Cream
Hide Arm/Group Description:

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

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: units on a scale
41
(0 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluocinonide Cream
Hide Arm/Group Description

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

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.

All-Cause Mortality
Fluocinonide Cream
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fluocinonide Cream
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluocinonide Cream
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steve Feldman MD
Organization: Wake Forest University Health Sciences
Phone: 336-716=3775
EMail: sfeldman@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT01469767     History of Changes
Other Study ID Numbers: IRB00018876
First Submitted: November 7, 2011
First Posted: November 10, 2011
Results First Submitted: January 27, 2017
Results First Posted: May 1, 2017
Last Update Posted: September 7, 2018