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

• ClinicalTrials.gov Identifier: NCT04360187
• Recruitment Status: Completed
• First Posted: April 24, 2020
• Results First Posted: May 2, 2022
• Last Update Posted: June 7, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: April 4, 2020
• First Posted Date: April 24, 2020
• Results First Submitted Date: April 3, 2022
• Results First Posted Date: May 2, 2022
• Last Update Posted Date: June 7, 2022
• Actual Study Start Date: July 27, 2020
• Actual Primary Completion Date: September 8, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 3, 2022)

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29 [ Time Frame: Baseline, Day 29 ]
  The EASI quantifies the severity of a participant'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. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
• Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 60 ]
  An adverse event was considered as a treatment-emergent adverse event (TEAE) if the event started after the first dose of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. 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. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
• Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters [ Time Frame: Baseline up to Day 29 ]
  Laboratory parameters included: hematology and chemistry. Clinically significant laboratory abnormalities are defined as abnormal values that have clinical manifestations or require medical intervention. Clinically significant laboratory criteria included Hemoglobin <0.8 x lower limit of normal (LLN), Leukocytes >1.5 x upper limit of normal (ULN), Lymphocytes <0.8 x LLN, Lymphocytes/Leukocytes >1.2 x ULN, Neutrophils <0.8 x LLN, Neutrophils >1.2x ULN, Neutrophils/Leukocytes <0.8 x LLN, Basophils/Leukocytes >1.2 x ULN, Eosinophils >1.2 x ULN, Eosinophils/Leukocytes >1.2 x ULN, Monocytes >1.2 x ULN, Monocytes/Leukocytes (%) >1.2 x ULN, Bicarbonate <0.9 x LLN, and Glucose >1.5x ULN.
• Percentage of Participants 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 participants in the seated position, after having sat/lied calmly for at least 5 minutes. Clinically significant vital signs criteria included Diastolic Blood Pressure (DBP) Value <50 mmHg, DBP Change ≥20 mmHg increase, DBP Change ≥20 mmHg decrease, Pulse Rate Value >120 beats per minute (bpm), Systolic Blood Pressure (SBP) Value <90 mmHg, SBP Change ≥30 mmHg increase, SBP Change ≥30mmHg decrease

Original Primary Outcome Measures (submitted: April 21, 2020)

• 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.

Current Secondary Outcome Measures (submitted: April 3, 2022)

• Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29 [ Time Frame: Baseline, Day 29 ]
  ISGA assessed the severity of atopic dermatitis (AD) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Improvement in ISGA is defined as ISGA score of 0 or 1.
• Percentage of Participants Achieving Success in ISGA at Day 29 [ Time Frame: Baseline, Day 29 ]
  ISGA assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Success in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline.
• Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years [ Time Frame: Baseline, Week 4 ]
  Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 is no pruritus and 10 is worst itch imaginable. Change: score at Week 4 minus score at baseline.
• Percentage of Participants Achieving Success in ISGA Over Time [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29 ]
  ISGA assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Success in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline.
• Percentage of Participants Achieving Improvement in ISGA Over Time [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29 ]
  ISGA (Investigator's Static Global Assessment) assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Improvement in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) .
• Percent Change From Baseline in EASI Total Score Over Time [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29 ]
  The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of 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. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
• Change From Baseline in Percent Body Surface Area (%BSA) Over Time [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29 ]
  4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp was excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated.
• Percentage of Participants Achieving EASI-50 Over Time [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29 ]
  The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. EASI-50 is defined as EASI score has ≥50% improvement from baseline.
• Percentage of Participants Achieving EASI-75 Over Time [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29 ]
  The EASI quantifies the severity of a participant's AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. EASI-75 is defined as EASI score has ≥75% improvement from baseline.
• Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]
  Peak Pruritus NRS is participants-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 is no pruritus and 10 is worst itch imaginable. Change: score at observation minus score at baseline.
• Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]
  Patient Reported Itch Severity Scale is a 5-point scale indicating no itchy to very itchy (ranged from 0 to 4, where 0=no itch to 4=worst itch imaginable) for participants ≥6 and <12 years of age.
• Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]
  Observer Reported Itch Severity Scale is an 11-point (ranged from 0 to 10, where 0=no itch to 10=worst itch imaginable) scale and must be completed by the observer (caregivers of participants) for participants <6 years of age.
• Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time [ Time Frame: Baseline, Day 15, Day 29 ]
  The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. The questionnaire will be completed by all participants aged 16 years and older, based on the age at Screening Visit/time of informed consent/assent. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
• Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time [ Time Frame: Baseline, Day 15, Day 29 ]
  The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children's (aged 4-15 years) quality of life. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
• Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time [ Time Frame: Baseline, Day 15, Day 29 ]
  The IDQOL was completed by observer for participants aged 2-3 years, based on the age at the Screening Visit/time of informed consent/assent. The IDQOL is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score the more quality of life is impaired.
• Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time [ Time Frame: Baseline, Day 15, Day 29 ]
  The DFI was completed by all observer for participants aged 2-17 years, based on the age at Screening Visit/time of informed consent/assent. The minimum DFI score is 0; the maximum DFI score is 30. The higher score means worse outcome.
• Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years [ Time Frame: Baseline, Day 15, Day 29 ]
  The POEM is a validated 7-item measure used to assess the impact of AD over the past week. The POEM contains 7 symptom based questions with responses rating number of days each symptom is experienced over the past week, from 0 (no days) to 4 (every day), with a maximum score of 28. Higher score means worse outcome.
• Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years [ Time Frame: Baseline, Day 15, Day 29 ]
  The POEM is a validated 7-item measure used to assess the impact of AD over the past week. The POEM contains 7 symptom based questions with responses rating number of days each symptom is experienced over the past week, from 0 (no days) to 4 (every day), with a maximum score of 28. Higher score means worse outcome.
• Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]
  The PGIS (for participants 12 years and older) is a single item patient-rated measure of the participant's AD condition severity at a given point in time. This single item instrument uses a 7-point rating scale, which range from 1 to 7, where 1=Not present to 7=Extremely severe.
• Patient Global Impression of Change (PGIC) Score [ Time Frame: Day 8, Day 15, Day 22, Day 29 ]
  The PGIC (for participants 12 years and older) was used to determine global improvement as assessed by the participant or caregiver. It was used as an anchor to define a responder definition for the peak pruritus scales for 'clinically important responder' and as a sensitivity analysis for defining a 'clinical important difference' on the peak pruritus scales. This single item instrument is a 7-point rating scale, anchored by (1) 'very much improved' to (7) 'very much worse'.
• Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]
  The OGIS (for participants ≥2 and <12 years) is a single item observer-rated measure of the participant's AD condition severity at a given point in time. This single item instrument uses a 7-point rating scale, which ranged from 1 to 7, where 1=Not present to 7=Extremely severe.
• Observer Reported Global Impression of Change (OGIC) Score [ Time Frame: Day 8, Day 15, Day 22, Day 29 ]
  The OGIC (for participants ≥2 and <12 years ) was used to determine global improvement as assessed by the participant or caregiver. It was used as an anchor to define a responder definition for the peak pruritus scales for 'clinically important responder' and as a sensitivity analysis for defining a 'clinical important difference' on the peak pruritus scales. This single item instrument is a 7-point rating scale, anchored by (1) 'very much improved' to (7) 'very much worse'.

Original Secondary Outcome Measures (submitted: April 21, 2020)

• Achievement of improvement in Investigator's Static Global Assessment (ISGA) at Day 29 [ Time Frame: Day 29 ]
  ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Improvement in ISGA is defined as ISGA score of 0 or 1.
• Achievement of Success in ISGA at Day 29 [ Time Frame: Baseline, Day 29 ]
  Success in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline.
• Change from Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for subjects ≥12 years [ Time Frame: Baseline, Week 4 ]
  Subjects-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point Numeric Rating Score (NRS) where 0 is no pruritus and 10 is worst itch imaginable. Change: score at observation minus score at baseline.
• Success in ISGA over time [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29 ]
  Success in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from Baseline.
• Improvement in ISGA over time [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29 ]
  ISGA(Investigator's Static Global Assessment) assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Improvement in ISGA is defined as an ISGA score of Clear (0) or Almost Clear (1) .
• Percent change from Baseline in EASI total score over time [ Time Frame: Baseline, Day 8, Day 15, Day 22, 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.
• Change from Baseline in % BSA over time [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29 ]
  4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp was excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated.
• Achievement of EASI-50 over time [ Time Frame: Baseline, Day 8, Day 15, Day 22, 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. The EASI score can vary in increments of range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. EASI-50 is defined as EASI score has ≥50% improvement from baseline
• Achievement of EASI-75 over time [ Time Frame: Baseline, Day 8, Day 15, Day 22, 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. The EASI score can vary in increments of range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. EASI-75 is defined as EASI score has ≥75% improvement from baseline.
• Change from Baseline in Peak Pruritus NRS over time-for subjects ≥12 years [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29 ]
  Peak Pruritus Numerical Rating Scale (NRS) is subjects-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point Numeric Rating Score (NRS) where 0 is no pruritus and 10 is worst itch imaginable. Change: score at observation minus score at baseline.
• Change from Baseline in Patient Reported Itch Severity Scale over time-for subjects ≥6 years and <12 years. [ Time Frame: Baseline, Day 29 ]
  Patient Reported Itch Severity Scale is a five-point scale indicating no itchy to very itchy for subjects ≥6 and <12 years of age.
• Change from Baseline in Observer Reported Itch Severity Scale over time-for subjects <6 years. [ Time Frame: Baseline, Day 29 ]
  Observer Reported Itch Severity Scale is an 11-point (0-10 for no itch to worst itch imaginable) scale and must be completed by the observer (caregivers of subjects) for subjects <6 years of age.
• Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score over time [ Time Frame: Baseline, Day 15, Day 29 ]
  The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. The questionnaire will be completed by all subjects aged 16 years and older, based on the age at Screening Visit/time of informed consent/assent. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
• Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) Score over time [ Time Frame: Baseline, Day 15, Day 29 ]
  The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children's (aged 4-15 years) quality of life. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
• Change from Infants' Dermatitis Quality of Life Index (IDQOL) Total Score over time [ Time Frame: Baseline, Day 15, Day 29 ]
  The Infants' Dermatitis Quality of Life Index (IDQOL) will be completed by observer for subjects aged 2-3 years, based on the age at the Screening Visit/time of informed consent/assent. The IDQOL is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score the more quality of life is impaired.
• Change from Baseline in Dermatitis Family Impact Questionnaire (DFI) Score over time [ Time Frame: Baseline, Day 15, Day 29 ]
  The Dermatitis Family Impact Questionnaire (DFI) will be completed by all observer for subjects aged 2-17 years, based on the age at Screening Visit/time of informed consent/assent. The minimum DFI score is 0; the maximum DFI score is 30. The higher score means worse outcome.
• Change from Baseline in Patient-Oriented Eczema Measure (POEM) over time [ Time Frame: Baselne, Day 15, Day 29 ]
  The POEM is a validated 7-item measure used to assess the impact of AD over the past week. The POEM contains 7 symptom based questions with responses rating number of days each symptom is experienced over the past week, from 0 (no days) to 4 (every day), with a maximum score of 28. Higher score means worse outcome.
• Change from Baseline in weekly average of Patient Global Impression of Severity (PGIS) score [ Time Frame: Baseline to Day 29 ]
  The PGIS is a single item patient-rated measure of the subject's AD condition severity at a given point in time. This single item instrument uses a 7-point rating scale. The PGIS will be used daily as an anchor for defining a 'clinical important difference' on the pruritus and itch assessments and can also be used to create severity categorization for pruritus and itch assessments to enhance interpretation. Higher score means worse outcome.
• Patient Global Impression of Change (PGIC) score [ Time Frame: Day 8, Day 15, Day 22, Day 29 ]
  The PGIC is an one item- question to rate change in a patient's overall status. This single item instrument is a 7-point rating scale and will be used to determine global improvement. It will be used as an anchor to define a responder definition for the pruritus and itch assessments for 'clinically important responder' and as a sensitivity analysis for defining a 'clinical important difference' for pruritus and itch assessments. Higher score means worse outcome.
• Change from Baseline in weekly average of Observer Reported Global Impression of Severity (OGIS) score [ Time Frame: Baseline to Day 29 ]
  The OGIS is a single item observer-rated measure of the subject's AD condition severity at a given point in time. This single item instrument uses a 7-point rating scale. The OGIS will be used daily as an anchor for defining a 'clinical important difference' on the pruritus and itch assessments and can also be used to create severity categorization for pruritus and itch assessments to enhance interpretation. Higher score means worse outcome.
• Observer Reported Global Impression of Change (OGIC) score [ Time Frame: Day 8, Day 15, Day 22, Day 29 ]
  The OGIC is an one item- question to rate change in a patient's overall status. This single item instrument is a 7-point rating scale and will be used to determine global improvement. It will be used as an anchor to define a responder definition for the pruritus and itch assessments for 'clinically important responder' and as a sensitivity analysis for defining a 'clinical important difference' for pruritus and itch assessments. Higher score means worse outcome.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
• Official Title: 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
• 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 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Atopic Dermatitis

Intervention

• Drug: Crisaborole Ointment
  Crisaborole ointment 2%
• Drug: Crisaborole Placebo Vehicle
  Placebo for crisaborole ointment

Study Arms

• Experimental: Crisaborole ointment
  Crisaborole ointment application twice daily for 28 days
  Intervention: Drug: Crisaborole Ointment
• Placebo Comparator: Crisaborole Placebo Vehicle
  Vehicle Ointment application twice daily for 28 days
  Intervention: Drug: Crisaborole Placebo Vehicle

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 28, 2021): 391
• Original Estimated Enrollment (submitted: April 21, 2020): 732
• Actual Study Completion Date: September 8, 2021
• Actual Primary Completion Date: September 8, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China, Japan, Korea, Republic of
• Removed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT04360187
• Other Study ID Numbers: C3291032
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2022