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
  Purpose

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.


Condition Intervention
Atopic Dermatitis
Drug: Fluocinonide cream

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Change in Investigator's Global Assessment of atopic dermatitis [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluocinonide cream
Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.
Drug: Fluocinonide cream
Fluocinonide cream 0.1% applied twice daily for 5 days.
Other Name: Vanos

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469767

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Susie Dowd    336-716-3775    sdowd@wakehealth.edu   
Contact: Adele Clark, PA-C    336-716-7465    adclark@wakehealth.edu   
Principal Investigator: Steven R Feldman, MD, PhD         
Sponsors and Collaborators
Wake Forest School of Medicine
Medicis Pharmaceutical Corporation
Investigators
Principal Investigator: Steven R Feldman, MD, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Steven R. Feldman, Professor of Dermatology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01469767     History of Changes
Other Study ID Numbers: 00018876
Study First Received: November 7, 2011
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
eczema
itch
scratching
actigraphy
adherence

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Fluocinonide
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014