Atopic Dermatitis
Conditions
Keywords
Skin barrier, Atopic Dermatitis, Corticosteroid, Effects on skin severity and barrier function
Brief summary
The purpose of this study is to determine the effect of short-term therapy using VANOS Cream, a super-potent topical steroid cream on skin barrier function in patients with atopic dermatitis. This cream is already approved for this indication, but the investigators will further examine its effects on the skin barrier. This cream is a novel formulation of fluocinonide designed to enhance compliance with a cream base, but have the skin barrier repair properties of an ointment.
Interventions
DRUGFluocinonide
Fluocinonide 0.1% cream topical daily for two weeks
Sponsors
Medicis Pharmaceutical Corporation
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of AD according to Hanifin-Rajka criteria (see Appendix B) * Age 12 years or older * Must have an Investigator's Global Assessment (IGA) Score of Moderate, Severe, or Very Severe (See Appendix C) * Must have failed to achieve adequate disease despite adequate topical or systemic therapy * Must be a candidate, according to the principal investigator and standard of care, for a super-potent topical steroid course. Subjects that are candidates for super-potent topical steroids are defined as subjects whose disease is not adequately controlled with medium-potency topical steroids or systemic therapy, including phototherapy.
Exclusion criteria
* Active skin infection * Hypersensitivity to any ingredients in Vanos cream * Previous use of super-potent topical steroids within 2 weeks of starting study (Class I steroid).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eczema Severity and Area Index | 2 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Transepidermal Water Loss | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vanos Cream glucocorticoid cream
Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Vanos Cream |
|---|---|
| Age, Continuous | 39 years |
| Race/Ethnicity, Customized African-American | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Caucasian, Non-Hispanic | 19 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized Mixed race | 1 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Change in Eczema Severity and Area Index
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.
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vanos Cream | Change in Eczema Severity and Area Index | 6.01 units | Standard Deviation 7.9 |
p-value: <0.01t-test, 2 sided
Secondary
Change in Transepidermal Water Loss
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).
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vanos Cream | Change in Transepidermal Water Loss | 14.35 G/m^2/hr | Standard Deviation 16 |
p-value: <0.01t-test, 2 sided