Trial Outcomes & Findings for Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis (NCT NCT01469767)

Last Updated: 2018-09-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

14 days

Results posted on

2018-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	Fluocinonide Cream 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 Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluocinonide Cream n=10 Participants Subjects will apply fluocinonide cream 0.1% twice daily for 5 days. Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	Fluocinonide Cream n=10 Participants Subjects will apply fluocinonide cream 0.1% twice daily for 5 days. Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.
IGA	1 units on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fluocinonide Cream n=10 Participants Subjects will apply fluocinonide cream 0.1% twice daily for 5 days. Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.
Actigraphy	85.7 Movement count per hour Standard Deviation 3.2

SECONDARY outcome

Timeframe: 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)."

Outcome measures

Outcome measures
Measure	Fluocinonide Cream n=10 Participants Subjects will apply fluocinonide cream 0.1% twice daily for 5 days. Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.
EASI	2.2 units on a scale Interval 0.2 to 23.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fluocinonide Cream n=10 Participants Subjects will apply fluocinonide cream 0.1% twice daily for 5 days. Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.
BSA	5.5 Percent BSA Interval 1.0 to 55.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fluocinonide Cream n=10 Participants Subjects will apply fluocinonide cream 0.1% twice daily for 5 days. Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.
VAS	41 units on a scale Interval 0.0 to 100.0

Adverse Events

Fluocinonide Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steve Feldman MD

Wake Forest University Health Sciences

Phone: 336-716=3775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place