Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
NCT ID: NCT04360187
Last Updated: 2022-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
391 participants
INTERVENTIONAL
2020-07-27
2021-09-08
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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Crisaborole ointment
Crisaborole ointment application twice daily for 28 days
Crisaborole Ointment
Crisaborole ointment 2%
Crisaborole Placebo Vehicle
Vehicle Ointment application twice daily for 28 days
Crisaborole Placebo Vehicle
Placebo for crisaborole ointment
Interventions
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Crisaborole Ointment
Crisaborole ointment 2%
Crisaborole Placebo Vehicle
Placebo for crisaborole ointment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Has participated in a previous crisaborole clinical study.
2 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First hospital of Jilin University
Changchun, Jilin, China
Shandong Provincial Institute of Dermatology and Venereology & Shandong Provincial Hospital for Skin
Jinan, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Hangzhou Third Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital/Dermatology Department
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The first Affiliated hospital of Wenzhou medical University
Wenzhou, Zhejiang, China
Peking University People's Hospital
Beijing, , China
Beijing Children's Hospital, Capital Medical University
Beijing, , China
The Second Affiliated Hospital of Army Medical University,PLA
Chongqing, , China
Children's Hospital of Shanghai
Shanghai, , China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, , China
Miyata Dermatology Clinic
Matsudo, Chiba, Japan
Shirao Clinic of Pediatrics and Pediatric Allergy
Hiroshima, Hiroshima, Japan
Motomachi Dermatology Clinic
Asahikawa-shi, Hokkaido, Japan
Chitose dermatology and plastic surgery clinic
Chitose Shi, Hokkaido, Japan
Takagi Dermatological Clinic
Obihiro, Hokkaido, Japan
Yoshimura Child Clinic
Akashi, Hyōgo, Japan
Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic
Kobe, Hyōgo, Japan
Nomura Dermatology Clinic
Yokohama, Kanagawa, Japan
Noguchi Dermatology Clinic
Kamimashiki-gun, Kumamoto, Japan
Yoshioka Dermatology Clinic
Neyagawa, Osaka, Japan
Kume Clinic
Sakai, Osaka, Japan
Mildix Skin Clinic
Adachi-ku, Tokyo, Japan
Yoga Allergy Clinic
Setagaya-ku, Tokyo, Japan
Sugamo Kobayashi Derma Clinic
Toshima-Ku, Tokyo, Japan
Sugamo Sengoku Dermatology
Toshima-Ku, Tokyo, Japan
Hoshikuma Dermatology・Allergy Clinic
Fukuoka, , Japan
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Countries
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References
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Ma L, Tao X, Liu S, Cheng H, Fang R, Zhao Y, Cha A, Encinas GA, Zhou Y, Deng Y, Zhang J. Efficacy and Safety of Crisaborole Ointment 2% in Chinese Patients Aged >/= 2 Years with Mild to Moderate Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 May;14(5):1229-1243. doi: 10.1007/s13555-024-01156-6. Epub 2024 May 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3291032
Identifier Type: -
Identifier Source: org_study_id
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