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Phase 2 N=10 Treatment

Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis

Atopic Dermatitis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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