Atopic Dermatitis
Conditions
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).
Interventions
Crisaborole ointment 2%
DRUGCrisaborole Placebo Vehicle
Placebo for crisaborole ointment
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29 | 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) | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Success in ISGA Over Time | 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 | 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 | 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. |
| Percentage of Participants Achieving EASI-50 Over Time | 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 | 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 | 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 | 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 | 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 | 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 Percent Body Surface Area (%BSA) Over Time | 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. |
| Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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'. |
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time | 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. |
| Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29 | 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 | 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 | 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. |
Countries
China, Japan, South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Twice a Day (BID) Vehicle was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1. | 131 |
| Crisaborole 2% Twice a Day (BID) Crisaborole 2% was applied BID for 28 days to the Treatable BSA identified at Baseline/Day 1 and new AD lesions that appear after the Baseline/Day 1. | 260 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-Blind Treatment | Adverse Event | 9 | 11 |
| Double-Blind Treatment | Lack of Efficacy | 7 | 2 |
| Double-Blind Treatment | Physician Decision | 1 | 0 |
| Double-Blind Treatment | Withdrawal By Parent/Guardian | 2 | 0 |
| Double-Blind Treatment | Withdrawal by Subject | 4 | 2 |
| Follow-Up | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Vehicle Twice a Day (BID) | Total | Crisaborole 2% Twice a Day (BID) |
|---|---|---|---|
| Age, Customized 12-17 Years | 15 Participants | 40 Participants | 25 Participants |
| Age, Customized >=18 Years | 47 Participants | 159 Participants | 112 Participants |
| Age, Customized 2-11 Years | 69 Participants | 192 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants | 391 Participants | 260 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 131 Participants | 391 Participants | 260 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 64 Participants | 186 Participants | 122 Participants |
| Sex: Female, Male Male | 67 Participants | 205 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 0 / 260 |
| other Total, other adverse events | 43 / 131 | 101 / 260 |
| serious Total, serious adverse events | 1 / 131 | 1 / 260 |
Outcome results
Primary
Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
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.
Time frame: Baseline up to Day 29
Population: The Safety Analysis Set included all participants who were randomized and received at least 1 confirmed dose of investigational product. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for each row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Hemoglobin (g/L) <0.8 x lower limit of normal (LLN) | 1.6 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Leukocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Lymphocytes (10^9/L) <0.8 x LLN | 0.8 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Lymphocytes/Leukocytes (%) >1.2 x ULN | 3.2 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Neutrophils (10^9/L) <0.8 x LLN | 0 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Neutrophils (10^9/L) >1.2 x ULN | 0 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Neutrophils/Leukocytes (%) <0.8 x LLN | 3.2 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Basophils/Leukocytes (%) >1.2 x ULN | 4.8 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Eosinophils (10^9/L) >1.2 x ULN | 33.1 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Eosinophils/Leukocytes (%) >1.2 x ULN | 29.8 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Monocytes (10^9/L) >1.2 x ULN | 0 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Monocytes/Leukocytes (%) >1.2 x ULN | 1.6 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Bicarbonate (mmol/L) <0.9 x LLN | 0.8 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Glucose (mmol/L) >1.5 x ULN | 0 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Monocytes (10^9/L) >1.2 x ULN | 0.4 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Hemoglobin (g/L) <0.8 x lower limit of normal (LLN) | 0 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Basophils/Leukocytes (%) >1.2 x ULN | 3.1 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Leukocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0.4 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Bicarbonate (mmol/L) <0.9 x LLN | 0.8 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Lymphocytes (10^9/L) <0.8 x LLN | 0 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Eosinophils (10^9/L) >1.2 x ULN | 31.1 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Lymphocytes/Leukocytes (%) >1.2 x ULN | 1.9 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Monocytes/Leukocytes (%) >1.2 x ULN | 1.6 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Neutrophils (10^9/L) <0.8 x LLN | 0.4 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Eosinophils/Leukocytes (%) >1.2 x ULN | 33.1 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Neutrophils (10^9/L) >1.2 x ULN | 0.4 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Glucose (mmol/L) >1.5 x ULN | 0.8 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters | Neutrophils/Leukocytes (%) <0.8 x LLN | 2.7 Percentage of Participants |
Primary
Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs
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
Time frame: Baseline up to Day 29
Population: The Safety Analysis Set included all participants who were randomized and received at least 1 confirmed dose of investigational product. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure for each row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Pulse Rate (bpm) Value >120 beats per minute (bpm) | 2.3 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Diastolic Blood Pressure (mmHg) Value <50 mmHg | 7.8 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Systolic Blood Pressure (mmHg) Value <90mmHg | 23.3 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Diastolic Blood Pressure (mmHg) Change ≥20mmHg decrease | 3.9 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Systolic Blood Pressure (mmHg) Change ≥30mmHg increase | 0 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Systolic Blood Pressure (mmHg) Change ≥30mmHg decrease | 3.1 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Diastolic Blood Pressure (mmHg) Change ≥20mmHg increase | 2.3 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Systolic Blood Pressure (mmHg) Change ≥30mmHg decrease | 0.8 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Diastolic Blood Pressure (mmHg) Value <50 mmHg | 7.3 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Diastolic Blood Pressure (mmHg) Change ≥20mmHg increase | 3.5 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Diastolic Blood Pressure (mmHg) Change ≥20mmHg decrease | 3.1 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Pulse Rate (bpm) Value >120 beats per minute (bpm) | 1.9 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Systolic Blood Pressure (mmHg) Value <90mmHg | 26.3 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Systolic Blood Pressure (mmHg) Change ≥30mmHg increase | 2.3 Percentage of Participants |
Primary
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
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.
Time frame: Baseline up to Day 60
Population: Overall number of participants analyzed included all participants who were randomized and received at least 1 confirmed dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Participants With Adverse Events | 44.3 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Participants With Serious Adverse Events | 0.8 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Participants With Severe Adverse Events | 1.5 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Participants Discontinued From Study Due to Adverse Events | 0.8 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Participants Discontinued From Study Due to Adverse Events | 0 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Participants With Adverse Events | 46.2 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Participants With Severe Adverse Events | 0 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Participants With Serious Adverse Events | 0.4 Percentage of Participants |
Primary
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at 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.
Time frame: Baseline, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Vehicle Twice a Day (BID) | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29 | -42.79 Percent Change |
| Crisaborole 2% Twice a Day (BID) | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29 | -59.92 Percent Change |
p-value: 0.000295% CI: [-25.98, -8.27]Mixed effect Model for Repeated Measures
Secondary
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time
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.
Time frame: Baseline, Day 15, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged 4-15 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time | Day 29 | -1.8 Units on a Scale | Standard Deviation 6 |
| Vehicle Twice a Day (BID) | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time | Day 15 | -1.3 Units on a Scale | Standard Deviation 5.18 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time | Day 15 | -3.6 Units on a Scale | Standard Deviation 4.64 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time | Day 29 | -3.9 Units on a Scale | Standard Deviation 5.37 |
Secondary
Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time
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.
Time frame: Baseline, Day 15, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged 2-17 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time | Day 15 | -0.5 Units on a Scale | Standard Deviation 3.87 |
| Vehicle Twice a Day (BID) | Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time | Day 29 | -2.1 Units on a Scale | Standard Deviation 4.86 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time | Day 15 | -2.4 Units on a Scale | Standard Deviation 4.66 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time | Day 29 | -3.0 Units on a Scale | Standard Deviation 5.22 |
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
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.
Time frame: Baseline, Day 15, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥16 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Day 15 | -1.1 Units on a Scale | Standard Deviation 4.02 |
| Vehicle Twice a Day (BID) | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Day 29 | -1.5 Units on a Scale | Standard Deviation 4.67 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Day 15 | -1.7 Units on a Scale | Standard Deviation 3.57 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time | Day 29 | -1.8 Units on a Scale | Standard Deviation 4.11 |
Secondary
Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years
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.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged \<6 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years | Week 1 | -0.31 Units on a Scale |
| Vehicle Twice a Day (BID) | Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years | Week 2 | -0.73 Units on a Scale |
| Vehicle Twice a Day (BID) | Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years | Week 3 | -0.96 Units on a Scale |
| Vehicle Twice a Day (BID) | Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years | Week 4 | -1.25 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years | Week 4 | -1.95 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years | Week 1 | -1.03 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years | Week 3 | -1.79 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years | Week 2 | -1.68 Units on a Scale |
Secondary
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years
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.
Time frame: Baseline, Day 15, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years | Day 15 | -1.8 Units on a Scale | Standard Deviation 5.25 |
| Vehicle Twice a Day (BID) | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years | Day 29 | -3.3 Units on a Scale | Standard Deviation 5.38 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years | Day 15 | -5.4 Units on a Scale | Standard Deviation 5.19 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years | Day 29 | -5.7 Units on a Scale | Standard Deviation 6.32 |
Secondary
Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years
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.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥ 6 and \<12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years | Week 1 | -0.26 Units on a Scale |
| Vehicle Twice a Day (BID) | Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years | Week 3 | -0.37 Units on a Scale |
| Vehicle Twice a Day (BID) | Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years | Week 2 | -0.22 Units on a Scale |
| Vehicle Twice a Day (BID) | Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years | Week 4 | -0.52 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years | Week 2 | -0.70 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years | Week 1 | -0.51 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years | Week 4 | -0.86 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years | Week 3 | -0.78 Units on a Scale |
Secondary
Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years
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.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years | Week 1 | -0.38 Units on a Scale |
| Vehicle Twice a Day (BID) | Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years | Week 2 | -0.53 Units on a Scale |
| Vehicle Twice a Day (BID) | Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years | Week 3 | -0.64 Units on a Scale |
| Vehicle Twice a Day (BID) | Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years | Week 4 | -0.79 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years | Week 4 | -1.58 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years | Week 1 | -0.94 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years | Week 3 | -1.41 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years | Week 2 | -1.26 Units on a Scale |
Secondary
Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years
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.
Time frame: Baseline, Week 4
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years | -0.79 Units on a Scale |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years | -1.58 Units on a Scale |
p-value: 0.000995% CI: [-1.26, -0.33]Mixed effect Model for Repeated Measures
Secondary
Change From Baseline in Percent Body Surface Area (%BSA) Over Time
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.
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Percent Body Surface Area (%BSA) Over Time | Day 8 | -1.75 Percentage BSA |
| Vehicle Twice a Day (BID) | Change From Baseline in Percent Body Surface Area (%BSA) Over Time | Day 15 | -3.31 Percentage BSA |
| Vehicle Twice a Day (BID) | Change From Baseline in Percent Body Surface Area (%BSA) Over Time | Day 22 | -4.38 Percentage BSA |
| Vehicle Twice a Day (BID) | Change From Baseline in Percent Body Surface Area (%BSA) Over Time | Day 29 | -4.81 Percentage BSA |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Percent Body Surface Area (%BSA) Over Time | Day 29 | -9.89 Percentage BSA |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Percent Body Surface Area (%BSA) Over Time | Day 8 | -5.12 Percentage BSA |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Percent Body Surface Area (%BSA) Over Time | Day 22 | -8.72 Percentage BSA |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Percent Body Surface Area (%BSA) Over Time | Day 15 | -7.60 Percentage BSA |
Secondary
Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years
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.
Time frame: Baseline, Day 15, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥2 and \<12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years | Day 15 | -2.5 Units on a Scale | Standard Deviation 5.17 |
| Vehicle Twice a Day (BID) | Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years | Day 29 | -3.8 Units on a Scale | Standard Deviation 5.33 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years | Day 15 | -6.7 Units on a Scale | Standard Deviation 6.09 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years | Day 29 | -7.7 Units on a Scale | Standard Deviation 5.41 |
Secondary
Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score
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.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥2 and \<12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score | Week 1 | -0.12 Units on a Scale | Standard Deviation 0.593 |
| Vehicle Twice a Day (BID) | Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score | Week 2 | -0.27 Units on a Scale | Standard Deviation 0.617 |
| Vehicle Twice a Day (BID) | Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score | Week 3 | -0.41 Units on a Scale | Standard Deviation 0.77 |
| Vehicle Twice a Day (BID) | Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score | Week 4 | -0.54 Units on a Scale | Standard Deviation 0.854 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score | Week 2 | -0.93 Units on a Scale | Standard Deviation 0.794 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score | Week 4 | -1.14 Units on a Scale | Standard Deviation 0.893 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score | Week 1 | -0.62 Units on a Scale | Standard Deviation 0.667 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score | Week 3 | -1.03 Units on a Scale | Standard Deviation 0.822 |
Secondary
Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score
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.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score | Week 1 | -0.24 Units on a Scale | Standard Deviation 0.511 |
| Vehicle Twice a Day (BID) | Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score | Week 2 | -0.26 Units on a Scale | Standard Deviation 0.692 |
| Vehicle Twice a Day (BID) | Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score | Week 3 | -0.38 Units on a Scale | Standard Deviation 0.871 |
| Vehicle Twice a Day (BID) | Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score | Week 4 | -0.44 Units on a Scale | Standard Deviation 0.965 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score | Week 4 | -0.71 Units on a Scale | Standard Deviation 1.028 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score | Week 1 | -0.43 Units on a Scale | Standard Deviation 0.649 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score | Week 3 | -0.66 Units on a Scale | Standard Deviation 0.913 |
| Crisaborole 2% Twice a Day (BID) | Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score | Week 2 | -0.60 Units on a Scale | Standard Deviation 0.836 |
Secondary
Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time
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.
Time frame: Baseline, Day 15, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged 2-3 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice a Day (BID) | Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time | Day 15 | -1.3 Units on a Scale | Standard Deviation 3.34 |
| Vehicle Twice a Day (BID) | Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time | Day 29 | -0.7 Units on a Scale | Standard Deviation 3.86 |
| Crisaborole 2% Twice a Day (BID) | Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time | Day 15 | -3.0 Units on a Scale | Standard Deviation 3.3 |
| Crisaborole 2% Twice a Day (BID) | Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time | Day 29 | -4.3 Units on a Scale | Standard Deviation 4.44 |
Secondary
Observer Reported Global Impression of Change (OGIC) Score
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'.
Time frame: Day 8, Day 15, Day 22, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥2 and \<12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice a Day (BID) | Observer Reported Global Impression of Change (OGIC) Score | Day 8 | 3.0 Units on a Scale | Standard Deviation 1.08 |
| Vehicle Twice a Day (BID) | Observer Reported Global Impression of Change (OGIC) Score | Day 15 | 3.0 Units on a Scale | Standard Deviation 1.1 |
| Vehicle Twice a Day (BID) | Observer Reported Global Impression of Change (OGIC) Score | Day 22 | 2.9 Units on a Scale | Standard Deviation 1.16 |
| Vehicle Twice a Day (BID) | Observer Reported Global Impression of Change (OGIC) Score | Day 29 | 2.8 Units on a Scale | Standard Deviation 1.07 |
| Crisaborole 2% Twice a Day (BID) | Observer Reported Global Impression of Change (OGIC) Score | Day 29 | 2.2 Units on a Scale | Standard Deviation 1.05 |
| Crisaborole 2% Twice a Day (BID) | Observer Reported Global Impression of Change (OGIC) Score | Day 8 | 2.3 Units on a Scale | Standard Deviation 0.81 |
| Crisaborole 2% Twice a Day (BID) | Observer Reported Global Impression of Change (OGIC) Score | Day 22 | 2.4 Units on a Scale | Standard Deviation 0.99 |
| Crisaborole 2% Twice a Day (BID) | Observer Reported Global Impression of Change (OGIC) Score | Day 15 | 2.3 Units on a Scale | Standard Deviation 0.92 |
Secondary
Patient Global Impression of Change (PGIC) Score
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'.
Time frame: Day 8, Day 15, Day 22, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug and aged ≥12 years. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice a Day (BID) | Patient Global Impression of Change (PGIC) Score | Day 15 | 3.2 Units on a Scale | Standard Deviation 1.1 |
| Vehicle Twice a Day (BID) | Patient Global Impression of Change (PGIC) Score | Day 22 | 3.0 Units on a Scale | Standard Deviation 1.19 |
| Vehicle Twice a Day (BID) | Patient Global Impression of Change (PGIC) Score | Day 29 | 2.9 Units on a Scale | Standard Deviation 1.21 |
| Vehicle Twice a Day (BID) | Patient Global Impression of Change (PGIC) Score | Day 8 | 3.3 Units on a Scale | Standard Deviation 1.05 |
| Crisaborole 2% Twice a Day (BID) | Patient Global Impression of Change (PGIC) Score | Day 8 | 2.6 Units on a Scale | Standard Deviation 1.1 |
| Crisaborole 2% Twice a Day (BID) | Patient Global Impression of Change (PGIC) Score | Day 15 | 2.6 Units on a Scale | Standard Deviation 1.07 |
| Crisaborole 2% Twice a Day (BID) | Patient Global Impression of Change (PGIC) Score | Day 29 | 2.5 Units on a Scale | Standard Deviation 1.12 |
| Crisaborole 2% Twice a Day (BID) | Patient Global Impression of Change (PGIC) Score | Day 22 | 2.6 Units on a Scale | Standard Deviation 1.04 |
Secondary
Percentage of Participants Achieving EASI-50 Over Time
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.
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving EASI-50 Over Time | Day 15 | 32.7 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving EASI-50 Over Time | Day 22 | 42.2 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving EASI-50 Over Time | Day 29 | 49.4 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving EASI-50 Over Time | Day 8 | 18.5 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving EASI-50 Over Time | Day 8 | 37.1 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving EASI-50 Over Time | Day 15 | 58.9 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving EASI-50 Over Time | Day 29 | 72.7 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving EASI-50 Over Time | Day 22 | 66.4 Percentage of Participants |
Secondary
Percentage of Participants Achieving EASI-75 Over Time
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.
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving EASI-75 Over Time | Day 8 | 6.1 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving EASI-75 Over Time | Day 15 | 15.4 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving EASI-75 Over Time | Day 22 | 26.3 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving EASI-75 Over Time | Day 29 | 27.6 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving EASI-75 Over Time | Day 29 | 46.4 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving EASI-75 Over Time | Day 8 | 11.2 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving EASI-75 Over Time | Day 22 | 38.2 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving EASI-75 Over Time | Day 15 | 26.3 Percentage of Participants |
Secondary
Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at 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.
Time frame: Baseline, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29 | 28.5 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29 | 41.4 Percentage of Participants |
p-value: 0.012495% CI: [2.8, 23.1]normal approximation to response rates
Secondary
Percentage of Participants Achieving Improvement in ISGA Over Time
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) .
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving Improvement in ISGA Over Time | Day 8 | 7.8 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving Improvement in ISGA Over Time | Day 15 | 18.3 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving Improvement in ISGA Over Time | Day 22 | 25.1 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving Improvement in ISGA Over Time | Day 29 | 28.5 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving Improvement in ISGA Over Time | Day 29 | 41.4 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving Improvement in ISGA Over Time | Day 8 | 16.8 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving Improvement in ISGA Over Time | Day 22 | 32.3 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving Improvement in ISGA Over Time | Day 15 | 25.6 Percentage of Participants |
Secondary
Percentage of Participants Achieving Success in ISGA at 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.
Time frame: Baseline, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving Success in ISGA at Day 29 | 15.9 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving Success in ISGA at Day 29 | 27.6 Percentage of Participants |
p-value: 0.007895% CI: [3.1, 20.3]normal approximation to response rates
Secondary
Percentage of Participants Achieving Success in ISGA Over Time
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.
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving Success in ISGA Over Time | Day 8 | 0.0 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving Success in ISGA Over Time | Day 15 | 4.9 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving Success in ISGA Over Time | Day 22 | 10.8 Percentage of Participants |
| Vehicle Twice a Day (BID) | Percentage of Participants Achieving Success in ISGA Over Time | Day 29 | 15.9 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving Success in ISGA Over Time | Day 29 | 27.6 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving Success in ISGA Over Time | Day 8 | 4.8 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving Success in ISGA Over Time | Day 22 | 18.1 Percentage of Participants |
| Crisaborole 2% Twice a Day (BID) | Percentage of Participants Achieving Success in ISGA Over Time | Day 15 | 11.6 Percentage of Participants |
Secondary
Percent Change From Baseline in EASI Total Score Over Time
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.
Time frame: Baseline, Day 8, Day 15, Day 22, Day 29
Population: Overall number of participants analyzed included all participants randomized and dispensed study drug. Participants were assigned to the randomized treatment regardless of what treatment was received. Number analyzed=participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Vehicle Twice a Day (BID) | Percent Change From Baseline in EASI Total Score Over Time | Day 8 | -21.43 Percent Change |
| Vehicle Twice a Day (BID) | Percent Change From Baseline in EASI Total Score Over Time | Day 15 | -37.15 Percent Change |
| Vehicle Twice a Day (BID) | Percent Change From Baseline in EASI Total Score Over Time | Day 22 | -42.92 Percent Change |
| Vehicle Twice a Day (BID) | Percent Change From Baseline in EASI Total Score Over Time | Day 29 | -42.79 Percent Change |
| Crisaborole 2% Twice a Day (BID) | Percent Change From Baseline in EASI Total Score Over Time | Day 29 | -59.92 Percent Change |
| Crisaborole 2% Twice a Day (BID) | Percent Change From Baseline in EASI Total Score Over Time | Day 8 | -36.65 Percent Change |
| Crisaborole 2% Twice a Day (BID) | Percent Change From Baseline in EASI Total Score Over Time | Day 22 | -55.05 Percent Change |
| Crisaborole 2% Twice a Day (BID) | Percent Change From Baseline in EASI Total Score Over Time | Day 15 | -49.65 Percent Change |