Phase 2
N=10
Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT01469767 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: IGA — 1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluocinonide cream (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Wake Forest University
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IGA |
1 | — |
| SECONDARY Actigraphy |
85.7 | — |
| SECONDARY EASI |
2.2 | — |
| SECONDARY BSA |
5.5 | — |
| SECONDARY VAS |
41 | — |
Summary
The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).
Eligibility Criteria
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 (parent permission and assent if applicable).
- Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 through 4 in the Investigator Global Assessment).
- Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on a 100-point scale.
- Percentage of overall body surface area of involvement (BSA) must be ≥2%.
- Women of childbearing potential will be allowed to participate in the study, and will be required to use at least one form of birth control.
Exclusion Criteria
- Use within four weeks from Baseline any systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.
- Application or use within two weeks of Baseline 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.
- Use of anti-histamines while participating in the study will not be permitted unless the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the subject must remain on a stable dose of anti-histamine throughout the study period. If a patient meets such criteria for anti-histamine use, this will be noted in the subject's chart.
- 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
- Women who are breastfeeding
Data sourced from ClinicalTrials.gov (NCT01469767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.