Phase 4
Completed N=25
VANOS Cream and Skin Barrier Function
Source: ClinicalTrials.gov NCT00819507 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Change in Eczema Severity and Area Index — 6.01 units — p=<0.01
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Eczema Severity and Area Index |
6.01 | <0.01 sig |
| SECONDARY Change in Transepidermal Water Loss |
14.35 | <0.01 sig |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00819507). 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.