Phase 4
Completed N=20
A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis
Source: ClinicalTrials.gov NCT01049243 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3. — -0.72 Scores on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3. |
-0.72 | — |
| SECONDARY Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14. |
2.4 | — |
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 (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.
Data sourced from ClinicalTrials.gov (NCT01049243). 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. Informational only — not medical advice.