Trial Outcomes & Findings for VANOS Cream and Skin Barrier Function (NCT NCT00819507)

NCT ID: NCT00819507

Last Updated: 2017-07-11

Results Overview

The eczema area and severity index (EAS I) is a validated composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and end of study (baseline EASI subtracted from end of study EASI) was calculated as a final outcome data point.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

2 Weeks

Results posted on

2017-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Vanos Cream glucocorticoid cream Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VANOS Cream and Skin Barrier Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vanos Cream n=25 Participants glucocorticoid cream Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks
Age, Continuous	39 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian, Non-Hispanic	19 Participants n=5 Participants
Race/Ethnicity, Customized African-American	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Race/Ethnicity, Customized Mixed race	1 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Weeks

Outcome measures

Outcome measures
Measure	Vanos Cream n=25 Participants glucocorticoid cream Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks
Change in Eczema Severity and Area Index	6.01 units Standard Deviation 7.9

SECONDARY outcome

Timeframe: 2 weeks

A measure of water flux out the skin using a small non-invasive probe. Values can range between 0-no water loss and over 100-severe water loss. This measure indicates the degree of skin barrier permeability with lower values indicating lower permeability (improved skin barrier function).

Outcome measures

Outcome measures
Measure	Vanos Cream n=25 Participants glucocorticoid cream Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks
Change in Transepidermal Water Loss	14.35 G/m^2/hr Standard Deviation 16

Adverse Events

Vanos Cream

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vanos Cream n=25 participants at risk glucocorticoid cream Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks
Skin and subcutaneous tissue disorders burning	4.0% 1/25 • Number of events 1

Additional Information

Eric Simpson

Oregon Health & Science University

Phone: 503-494-2121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place