This study will assess the safety and efficacy of Roflumilast cream versus vehicle applied once a day for 4 weeks by subjects with atopic dermatitis.
This is a parallel group, double blind, vehicle-controlled study in which Roflumilast cream or vehicle is applied once daily for 4 weeks to subjects with mild or moderate atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
354
Roflumilast cream 0.15% is applied once daily for 4 weeks
Vehicle cream is applied once daily for 4 weeks
Percentage of subjects with vIGA-AD success
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear). IGA sucess is defined as a vIGA-AD score of 'clear' or 'almost clear' plus at least 2-grade improvement from baseline
Time frame: Baseline, week 4
In subjects with moderate AD severity (vIGA-AD score of 3) at baseline, percentage of subjects with vIGA-AD success
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
Time frame: Baseline, week 4
Percentage of subjects with vIGA-AD of "clear" or "almost clear"
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
Time frame: Baseline, week 4
In subjects with WI-NRS ≥ 4 at baseline, percentage of subjects with ≥ 4 point reduction in WI-NRS
The Worst Itch Numerical Rating Scale (WI-NRS) will be determined by the subject's recording of daily assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst itch imaginable" or "worst imaginable itch").
Time frame: Baseline, week 4
Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)
EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). Four anatomic sites-head, upper extremities, trunk, and lower extremities-are assessed for erythema, induration/infiltration (papules), excoriation, and lichenification as seen on the day of the examination. To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
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The Second affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Aerospace General Hospital
Beijing, Beijing Municipality, China
Beijing Children's Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Chongqing Medical University Affiliated Second Hospital
Chongqing, Chongqing Municipality, China
People's Hospital Affiliated to Chongqing Three Gorges Medical College
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The Second affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
...and 51 more locations
Time frame: Baseline, week 4
Safety: treatment emergence adverse events
Incidence, severity, and causal relationship of treatment emergence adverse events (TEAE), TEAEs leading to withdrawal and death.
Time frame: Up to 4 weeks
Trough concentration (Ctrough)
Trough concentration of plasma roflumilast and its N-oxide
Time frame: Week 2, week 4