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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast cream 0.15% | Experimental | Active comparator |
|
| Vehicle cream | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast Cream 0.15% | Drug | Roflumilast cream 0.15% is applied once daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second affiliated Hospital of Wannan Medical College | Wuhu | Anhui | China | |||
| Beijing Aerospace General Hospital |
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| Vehicle cream | Drug | Vehicle cream is applied once daily for 4 weeks |
|
| 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). |
| 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"). | 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. | 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. | Up to 4 weeks |
| Trough concentration (Ctrough) | Trough concentration of plasma roflumilast and its N-oxide | Week 2, week 4 |
| 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 |
| The Sixth People's Hospital of Dongguan | Dongguan | Guangdong | China |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| The Second affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| Shenzhen Children's Hospital | Shenzhen | Guangdong | China |
| Union Shenzhen Hospital | Shenzhen | Guangdong | China |
| Liuzhou People's Hospital | Liuzhou | Guangxi | China |
| Hainan General Hospital | Haikou | Hainan | China |
| The Fifth People's Hospital of Hainan Province | Haikou | Hainan | China |
| Kunming Children's Hospital | Kunming | Hainan | China | China |
| Shijiazhuang People's Hospital | Shijiazhuang | Hebei | China |
| TCM Hospital of Shi Jia Zhuang City | Shijiazhuang | Hebei | China |
| Xingtai People's Hospital | Xingtai | Hebei | China |
| The Second Hospital affiliated to Henan University of Science and Technology | Luoyang | Henan | China |
| Nanyang Central Hospital | Nanyang | Henan | China |
| Sanmenxia Central Hospital | Sanmenxia | Henan | China |
| Henan Children's Hospital Zhengzhou Children's Hospital | Zhengzhou | Henan | China |
| Zhengzhou Central Hospital | Zhengzhou | Henan | China |
| Jingzhou Central Hospital | Jingzhou | Hubei | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | China |
| Yichang Central People's Hospital | Yichang | Hubei | China |
| The First People's Hospital of Changde City | Changde | Hunan | China |
| Hunan Children's Hospital | Changsha | Hunan | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Xiangya Hospital | Changsha | Hunan | China |
| Sir Run Run Hospital Nanjing Medical University | Nanjing | Jiangsu | China |
| J.Y Hospital of TCM | Wuxi | Jiangsu | China |
| People's hospital of Wuxi | Wuxi | Jiangsu | China |
| Wuxi Second People's Hospital | Wuxi | Jiangsu | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| Dermatology Hospital of Jiangxi Province | Nanchang | Jiangxi | China |
| The Second affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| The First Bethune Hospital of Jilin University | Changchun | Jilin | China |
| Dalian Dermatology Hospital | Dalian | Liaoning | China | China |
| Dalian Municipal Women and Children's Medical Center | Dalian | Liaoning | China |
| Panjin Liaohe Oilfield Gem Flower Hospital | Panjin | Liaoning | China |
| The First affiliated Hospital of Baotou College | Baotou | Neimenggu | China |
| Jinan Central Hospital | Jinan | Shandong | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | China |
| Liaocheng People's Hospital | Liaocheng | Shandong | China |
| Hiser Medical Center of Qingdao | Qingdao | Shandong | China |
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
| Shanghai Children's Hospital | Shanghai | Shanghai Municipality | China |
| The Second affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | China |
| Chengdu Second People's Hospital | Chengdu | Sichuan | China |
| Chengdu Women's and Children's Central Hospital | Chengdu | Sichuan | China |
| Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
| The First Hospital of Jiaxing | Jiaxing | Zhejiang | China |
| The Second Hospital of Jiaxing | Jiaxing | Zhejiang | China |
| The Second Hospital of Ningbo | Ningbo | Zhejiang | China |
| Taizhou Central Hospital | Taizhou | Zhejiang | China |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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