Clinical Trials List
2020-10-09 - 2020-12-10
Phase III
Terminated7
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT, 2% IN CHINESE AND JAPANESE PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
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Sponsor
Pfizer
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Yi-Hsien Shih Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 蕭百芬 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chun-Bing Chen Division of Dermatology
- Yu-Huei Huang Division of Dermatology
- Wen-Hung Chung Division of Dermatology
- Chun-Wei Lu Division of Dermatology
- I-Hsin Shih Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- 紀敏慧 Division of Dermatology
- 丁思文 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Cheng-Yuan Li Division of Dermatology
- DINGDAR LEE Division of Dermatology
- Yun-Ting Chang Division of Dermatology
- 吳貞宜 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 洪琡茹 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- WEI-HSIN WU Division of Dermatology
- Chih-Chieh Chan Division of Dermatology
- 卓雍哲 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Percent change from Baseline in Eczema Area and Severity Index (EASI) total score at Day 29 [ Time Frame: Baseline, Day 29 ]
The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
Percentage of subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 60 ]
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of subjects with clinically significant changes from Baseline in clinical laboratory parameters [ Time Frame: Baseline up to Day 29 ]
Laboratory parameters included: hematology and chemistry. Clinical significance of laboratory parameters was determined at the investigator's discretion.
Percentage of subjects with clinically significant changes from Baseline in vital signs [ Time Frame: Baseline up to Day 29 ]
Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with subjects in the seated position, after having sat/lied calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.
Inclution 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.
The Estimated Number of Participants
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Taiwan
40 participants
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Global
510 participants
