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.
|Study Design:||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 ]
- Change in Actigraphy Movement Count per Hour [ Time Frame: Baseline to 14 days ]
- Change in Eczema Area and Severity Index Score [ Time Frame: Baseline to 14 days ]
- Change in Body Surface Area of atopic dermatitis [ Time Frame: Baseline to 14 days ]
- Change in Visual Analog Scale for itch [ Time Frame: Baseline to 14 days ]
- Subject Global Assessment of atopic dermatitis [ Time Frame: 14 days ]
- Adherence to Fluocinonide Cream [ Time Frame: 14 days ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469767
|United States, North Carolina|
|Wake Forest University Health Sciences||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Susie Dowd 336-716-3775 firstname.lastname@example.org|
|Contact: Adele Clark, PA-C 336-716-7465 email@example.com|
|Principal Investigator: Steven R Feldman, MD, PhD|
|Principal Investigator:||Steven R Feldman, MD, PhD||Wake Forest University Health Sciences|