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Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis

NCT04360187

CompletedPhase 3

Sponsor: Pfizer

Conditions: Atopic Dermatitis

Interventions: Crisaborole Ointment, Crisaborole Placebo Vehicle

Countries: China, Japan, South Korea

This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).

Eligibility overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

\- Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA.

Exclusion Criteria:

* Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant physical examination finding at Screening that in the PI's or designee's opinion may interfere with study objectives.
* Has participated in a previous crisaborole clinical study.
Locations (39)
  • Beijing, Beijing Municipality, China
  • Guangzhou, Guangdong, China
  • Guangzhou, Guangdong, China
  • Guangzhou, Guangdong, China
  • Shantou, Guangdong, China
  • Shenzhen, Guangdong, China
  • Wuhan, Hubei, China
  • Changsha, Hunan, China
  • Changchun, Jilin, China
  • Jinan, Shandong, China
  • Shanghai, Shanghai Municipality, China
  • Tianjin, Tianjin Municipality, China
  • Kunming, Yunnan, China
  • Hangzhou, Zhejiang, China
  • Hangzhou, Zhejiang, China
  • Hangzhou, Zhejiang, China
  • Wenzhou, Zhejiang, China
  • Beijing, China
  • Beijing, China
  • Chongqing, China
  • Shanghai, China
  • Tianjin, China
  • Matsudo, Chiba, Japan
  • Hiroshima, Hiroshima, Japan
  • Asahikawa-shi, Hokkaido, Japan
  • Chitose Shi, Hokkaido, Japan
  • Obihiro, Hokkaido, Japan
  • Akashi, Hyōgo, Japan
  • Kobe, Hyōgo, Japan
  • Yokohama, Kanagawa, Japan
  • + 9 more on CT.gov