Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis
NCT ID: NCT06631170
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
354 participants
INTERVENTIONAL
2024-11-21
2025-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Roflumilast cream 0.15%
Active comparator
Roflumilast Cream 0.15%
Roflumilast cream 0.15% is applied once daily for 4 weeks
Vehicle cream
Placebo comparator
Vehicle cream
Vehicle cream is applied once daily for 4 weeks
Interventions
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Roflumilast Cream 0.15%
Roflumilast cream 0.15% is applied once daily for 4 weeks
Vehicle cream
Vehicle cream is applied once daily for 4 weeks
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with atopic dermatitis (AD) for at least 6 months for subjects aged ≥18 years and 3 months for subjects aged 6\~17 years at screening.
3. Have stable disease for the past 4 weeks prior to screening.
4. Have mild or moderate AD at baseline.
5. Have BSA affected by AD of 3%-20% at baseline.
6. Women of childbearing potential (WOCBP) have a negative pregnancy blood test at screening and a negative urine pregnancy test at baseline. WOCBP must have taken and agree to continue taking highly effective contraceptive measures from 4 weeks before the first dose to 2 months after the last dose.
7. Being in good health as judged by the Investigator.
8. Subjects voluntarily participate in the study and sign the ICF before the start of study-related activities.
Exclusion Criteria
2. Previous treatment with roflumilast cream.
3. Use of systemic treatments that affect the efficacy assessment of AD 4 weeks or 5 half-lives (whichever is longer) prior to the first dose.
4. Use of topical treatments that affect the efficacy assessment of AD 2 weeks prior to the first dose.
5. Use of phototherapy, tanning beds, or any other light-emitting devices within 4 weeks prior to the first dose.
6. Female subjects who are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.
7. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
8. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
9. Subjects/legal guardians who are unable to communicate, understand the study, or other situations deemed inappropriate for participation in a clinical trial by the investigator.
6 Years
ALL
No
Sponsors
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Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
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
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
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
Countries
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Other Identifiers
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HDM3014-2-301
Identifier Type: -
Identifier Source: org_study_id
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