Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Open-Label, Topical, Cream, Eczema, Vanos
Brief summary
The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days.
Detailed description
This is a single center study. This is an open label study of fluocinonide cream 0.1% (Vanos™) for subjects with mild to severe atopic dermatitis with an assessment of 2 to 4 on the Investigator Global Assessment scale (Appendix B). Up to 20 subjects age 12 and above will be enrolled after providing informed consent. All subjects will receive the study medication, fluocinonide cream 0.1% (Vanos™). Each subject will be instructed to use fluocinonide cream 0.1% (Vanos™) twice daily for three consecutive days (for a total of 6 doses). The study period will last for approximately 2 weeks. Subjects will be evaluated at baseline and Day 2 or 3 (as needed to achieve 6 doses), day 7 and day 14 (or end of study). Subjects will not apply any study drug after the 6 doses.
Interventions
DRUGFluocinonide Cream 0.1%
0.1% Cream, One Application, Twice Daily, 14 Days
Sponsors
Medicis Pharmaceutical Corporation
Wake Forest University Health Sciences
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
* Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (and assent if applicable) * Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 - 4 in the Investigator Global Assessment (Appendix B)) * Percentage of overall body surface are of involvement (BSA) must be ≥2% * Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control
Exclusion criteria
* Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids * Application or use within 2 weeks of baseline of topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome * Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments * Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study * Amount of disease involvement that would require \>60 gm of cream in a 1 week period * Subjects with known allergy or sensitivity to topical Vanos™ cream or components * Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3. | Baseline to 3 days | Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14. | Baseline to 14 days | Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clininc
Participants by arm
| Arm | Count |
|---|---|
| Single Group | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Single Group |
|---|---|
| Age, Continuous | 27 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 9 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 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.
Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.
Time frame: Baseline to 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3. | -0.72 Scores on a scale | Standard Deviation 0.57 |
Secondary
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.
Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.
Time frame: Baseline to 14 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Group | Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14. | 2.4 units on a scale |