Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
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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 |
- Change in Investigator's Global Assessment of atopic dermatitis [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
- 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: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (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 |
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| 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 | |
| Principal Investigator: | Steven R Feldman, MD, PhD | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Steven R. Feldman, Professor of Dermatology, Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01469767 History of Changes |
| Other Study ID Numbers: | 00018876 |
| Study First Received: | November 7, 2011 |
| Last Updated: | May 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
eczema itch scratching actigraphy adherence |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Fluocinonide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Allergic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 13, 2013