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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Wake Forest School of Medicine
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01469767
First received: November 7, 2011
Last updated: July 24, 2014
Last verified: July 2014

November 7, 2011
July 24, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
Change in Investigator's Global Assessment of atopic dermatitis [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01469767 on ClinicalTrials.gov Archive Site
  • Change in Actigraphy Movement Count per Hour [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
  • Change in Eczema Area and Severity Index Score [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
  • Change in Body Surface Area of atopic dermatitis [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
  • Change in Visual Analog Scale for itch [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
  • Subject Global Assessment of atopic dermatitis [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Adherence to Fluocinonide Cream [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis

The purpose of this study is to assess the efficacy and tolerability of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD). Our hypothesis is that subjects will have a reduction in Investigator's Global Assessment scores at Day 7 and Day 14 compared to Baseline.

Secondary objectives include the use of actigraphy monitoring to determine the ability of Vanos® cream to reduce itch, and thus nocturnal scratching, in AD. Our hypothesis is that subjects will have a reduction in nocturnal scratching activity, as measured by actigraphy movement count per hour, at Day 7 and Day 14 compared to Baseline. Other secondary outcome measures include Eczema Area and Severity Index (EASI) score, body surface area involvement, Visual Analog Scale for itch, and Subject Global Assessment. The investigators hypothesize that each of these measures will be improved at Day 7 and Day 14 compared to Baseline. Medication adherence will be determined using objective adherence monitors. The investigators also hypothesize that subjects will have improved adherence to a topical medication for AD, compared to published sources, if they are only required to use the medication for a short and defined duration.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atopic Dermatitis
Drug: Fluocinonide cream
Fluocinonide cream 0.1% applied twice daily for 5 days.
Other Name: Vanos
Experimental: Fluocinonide cream
Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Intervention: Drug: Fluocinonide cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
United States
 
NCT01469767
00018876
No
Steven R. Feldman, Wake Forest School of Medicine
Wake Forest School of Medicine
Medicis Pharmaceutical Corporation
Principal Investigator: Steven R Feldman, MD, PhD Wake Forest School of Medicine
Wake Forest School of Medicine
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP