Crisaborole for Asian Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
NCT04360187
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- 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.
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Crisaborole for Asian Subjects (?2 Years of Age) With Mild to Moderate Atopic Dermatitis | ||||||
Official Title ICMJE | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT 2% IN ASIAN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS | ||||||
Brief Summary | This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Asian 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). | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Atopic Dermatitis | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 732 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | November 30, 2021 | ||||||
Estimated Primary Completion Date | November 30, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | 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:
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Sex/Gender ICMJE |
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Ages ICMJE | 2 Years and older (Child, Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China, Japan, Korea, Republic of | ||||||
Removed Location Countries | Taiwan | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04360187 | ||||||
Other Study ID Numbers ICMJE | C3291032 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |