Atopic Dermatitis
Conditions
Brief summary
This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older, cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).
Interventions
BID regimen
DRUGVehicle
BID regimen
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
* Male or female participants ages; Cohort 1: 12 years and older at the time of consent. Cohort 2: 2 years to under 12 years old at the time of consent. * Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria and has at least 6 months history prior to screening and has been clinically stable for more than 1 month * Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals and groin area * Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.
Exclusion criteria
* Has other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * Participants had previous treatment with any topical or systemic PDE-4 inhibitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Baseline, Day 15 | Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Baseline, Day 8 | Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity. |
| Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Baseline, Day 8, Day 15 | ISGA assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (severe), where higher scores indicated higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, 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). |
| Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 | The severity of itch (pruritus) due to AD at the target lesion was assessed using the peak pruritus NRS. Participants aged 12 years or more, were asked to rate their itch severity at the worst moment during the past 24 hours on a scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores represented more severe itch. |
| Change From Baseline in Total Sign Score in Target Lesions at Day 15: Crisaborole Ointment 2% BID Versus Crisaborole Ointment 2% QD | Baseline, Day 15 | Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity. |
| Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 | Observer reported itch severity NRS was used for participants \>=2 and \< 12 years of age to assess severity of itch (pruritus) due to AD at the target lesion. Parents/caregivers (of participants) were asked to rate participants' itch (i.e. scratching, rubbing) at the worst moment during past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable); higher scores represented more severe itch. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Day 1 up to 35 days after end of treatment (maximum up to Day 50) | An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state. For this outcome measure, treatment-emergent AEs occurred at each treated target lesion were summarized. MedDRA version 22.1 coding dictionary was used. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen | Day 1 up to 35 days after end of treatment (maximum up to Day 50) | An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state. |
| Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 | The itch severity scale was used for participants \>=6 to 11 years of age to assess severity of itch (pruritus) due to AD at the target lesion. In this assessment, participants were asked to choose a unit that showed how itchy their skin had been on day of assessment on a 5-point scale ranging from 1= not itchy to 5= very itchy, where higher scores represented more severe itch. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Crisaborole 2% QD + Vehicle QD, Age Group >=12 Years Participants in this reporting arm were of age \>=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50). | 20 |
| Cohort 1:Crisaborole 2% BID + Vehicle BID,Age Group >=12 Years Participants in this reporting arm were of age \>=12 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50). | 21 |
| Cohort 2:Crisaborole 2% QD + Vehicle QD, Age Group 2-11 Years Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied QD to 1 of the target lesions and vehicle was applied QD to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50). | 20 |
| Cohort 2:Crisaborole 2% BID + Vehicle BID,Age Group 2-11 Years Participants in this reporting arm were of age 2 to 11 years. Investigator determined 2 target lesions of same AD severity in each participant at baseline (Day 1). Crisaborole ointment 2% was applied BID to 1 of the target lesions and vehicle was applied BID to another target lesion (intra-participant) for 15 days and participants were followed up to maximum of 35 days after the end of treatment (maximum up to Day 50). | 20 |
| Total | 81 |
Baseline characteristics
| Characteristic | Cohort 1: Crisaborole 2% QD + Vehicle QD, Age Group >=12 Years | Cohort 1:Crisaborole 2% BID + Vehicle BID,Age Group >=12 Years | Cohort 2:Crisaborole 2% QD + Vehicle QD, Age Group 2-11 Years | Cohort 2:Crisaborole 2% BID + Vehicle BID,Age Group 2-11 Years | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 20 Participants | 20 Participants | 41 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 21 Participants | 0 Participants | 0 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 21 Participants | 20 Participants | 20 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 21 Participants | 20 Participants | 20 Participants | 81 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 17 Participants | 8 Participants | 11 Participants | 47 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 12 Participants | 9 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 6 / 20 | 6 / 21 | 2 / 20 | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle
Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity.
Time frame: Baseline, Day 15
Population: FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Change at Day 15 | -4.5 units on a scale | Standard Error 0.6 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.7 units on a scale | Standard Error 0.36 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.5 units on a scale | Standard Error 0.45 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Change at Day 15 | -2.9 units on a scale | Standard Error 0.51 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.1 units on a scale | Standard Error 0.46 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Change at Day 15 | -4.8 units on a scale | Standard Error 0.53 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.4 units on a scale | Standard Error 0.48 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Change at Day 15 | -2.7 units on a scale | Standard Error 0.47 |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Baseline | 6.2 units on a scale | Standard Error 0.38 |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Change at Day 15 | -3.5 units on a scale | Standard Error 0.47 |
| Vehicle QD: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Baseline | 6.5 units on a scale | Standard Error 0.37 |
| Vehicle QD: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Change at Day 15 | -2.0 units on a scale | Standard Error 0.5 |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.1 units on a scale | Standard Error 0.45 |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Change at Day 15 | -4.7 units on a scale | Standard Error 0.5 |
| Vehicle BID: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Change at Day 15 | -2.6 units on a scale | Standard Error 0.54 |
| Vehicle BID: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.3 units on a scale | Standard Error 0.44 |
Comparison: Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures (MMRM) included the fixed effect of visit, and the covariance structure UN was used.p-value: 0.007195% CI: [-2.7, -0.5]Mixed Models Analysis
Comparison: Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.p-value: 0.002995% CI: [-3.3, -0.8]Mixed Models Analysis
Comparison: Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.p-value: 0.02595% CI: [-2.7, -0.2]Mixed Models Analysis
Comparison: Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.p-value: 0.001495% CI: [-3.3, -0.9]Mixed Models Analysis
Secondary
Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15
ISGA assessed the severity of AD on a 5-point scale ranged from 0 (clear) to 4 (severe), where higher scores indicated higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, 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).
Time frame: Baseline, Day 8, Day 15
Population: FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product. Here, Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 15 | -1.9 units on a scale | Standard Error 0.19 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 8 | -1.3 units on a scale | Standard Error 0.18 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Baseline | 3.0 units on a scale | Standard Error 0 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 15 | -1.0 units on a scale | Standard Error 0.15 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 8 | -0.8 units on a scale | Standard Error 0.12 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Baseline | 3.0 units on a scale | Standard Error 0 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 8 | -1.1 units on a scale | Standard Error 0.2 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Baseline | 3.0 units on a scale | Standard Error 0 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 15 | -1.9 units on a scale | Standard Error 0.19 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Baseline | 3.0 units on a scale | Standard Error 0 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 8 | -0.7 units on a scale | Standard Error 0.12 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 15 | -1.1 units on a scale | Standard Error 0.19 |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Baseline | 3.0 units on a scale | Standard Error 0 |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 8 | -1.4 units on a scale | Standard Error 0.19 |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 15 | -1.8 units on a scale | Standard Error 0.22 |
| Vehicle QD: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 15 | -1.1 units on a scale | Standard Error 0.19 |
| Vehicle QD: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Baseline | 3.0 units on a scale | Standard Error 0 |
| Vehicle QD: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 8 | -1.0 units on a scale | Standard Error 0.2 |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 15 | -1.9 units on a scale | Standard Error 0.16 |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 8 | -1.2 units on a scale | Standard Error 0.18 |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Baseline | 3.0 units on a scale | Standard Error 0 |
| Vehicle BID: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Baseline | 3.0 units on a scale | Standard Error 0 |
| Vehicle BID: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 8 | -0.8 units on a scale | Standard Error 0.16 |
| Vehicle BID: Age Group 2 to 11 Years | Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 | Change at Day 15 | -0.9 units on a scale | Standard Error 0.2 |
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-0.9, -0.1]
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-0.9, 0]
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-0.8, 0.1]
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-0.8, 0]
Comparison: Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.4, 0.6]
Comparison: Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.3, 0.7]
Comparison: Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-1.4, -0.4]
Comparison: Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-1.2, -0.2]
Comparison: Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-1.2, -0.2]
Comparison: Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-1.4, -0.6]
Comparison: Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.5, 0.6]
Comparison: Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.7, 0.5]
Secondary
Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years
The itch severity scale was used for participants \>=6 to 11 years of age to assess severity of itch (pruritus) due to AD at the target lesion. In this assessment, participants were asked to choose a unit that showed how itchy their skin had been on day of assessment on a 5-point scale ranging from 1= not itchy to 5= very itchy, where higher scores represented more severe itch.
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Population: Analysis population included all participants who were randomized and received greater than or equal to 1 dose of investigational product and aged between 6 to 11 years. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 11 | -1.1 units on a scale | Standard Error 0.34 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 9 | -0.6 units on a scale | Standard Error 0.38 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 10 | -0.8 units on a scale | Standard Error 0.37 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 4 | -0.4 units on a scale | Standard Error 0.45 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 2 | -0.7 units on a scale | Standard Error 0.36 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 14 | -0.9 units on a scale | Standard Error 0.36 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 12 | -0.8 units on a scale | Standard Error 0.32 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 5 | -0.6 units on a scale | Standard Error 0.41 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 8 | -1.1 units on a scale | Standard Error 0.3 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 15 | -0.8 units on a scale | Standard Error 0.38 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 13 | -0.8 units on a scale | Standard Error 0.37 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 6 | -0.8 units on a scale | Standard Error 0.37 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 7 | -0.3 units on a scale | Standard Error 0.46 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 3 | -0.4 units on a scale | Standard Error 0.35 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Baseline | 1.6 units on a scale | Standard Error 0.33 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 7 | -0.3 units on a scale | Standard Error 0.31 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 8 | -0.7 units on a scale | Standard Error 0.36 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 9 | -0.3 units on a scale | Standard Error 0.31 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 13 | -0.2 units on a scale | Standard Error 0.34 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 10 | -0.4 units on a scale | Standard Error 0.34 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 2 | -0.3 units on a scale | Standard Error 0.35 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 3 | -0.5 units on a scale | Standard Error 0.26 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 14 | -0.4 units on a scale | Standard Error 0.31 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 12 | 0.1 units on a scale | Standard Error 0.4 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 4 | -0.4 units on a scale | Standard Error 0.32 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 5 | -0.1 units on a scale | Standard Error 0.35 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Baseline | 1.8 units on a scale | Standard Error 0.32 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 11 | -0.5 units on a scale | Standard Error 0.38 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 6 | -0.4 units on a scale | Standard Error 0.34 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 15 | -0.6 units on a scale | Standard Error 0.26 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 7 | -0.9 units on a scale | Standard Error 0.45 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 8 | -1.1 units on a scale | Standard Error 0.44 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Baseline | 1.9 units on a scale | Standard Error 0.33 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 2 | -0.6 units on a scale | Standard Error 0.45 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 3 | -0.9 units on a scale | Standard Error 0.3 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 4 | -0.7 units on a scale | Standard Error 0.46 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 5 | -0.7 units on a scale | Standard Error 0.47 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 6 | -0.9 units on a scale | Standard Error 0.38 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 9 | -1.4 units on a scale | Standard Error 0.37 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 10 | -1.1 units on a scale | Standard Error 0.33 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 11 | -1.1 units on a scale | Standard Error 0.49 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 12 | -1.4 units on a scale | Standard Error 0.37 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 13 | -1.4 units on a scale | Standard Error 0.37 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 14 | -1.3 units on a scale | Standard Error 0.41 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 15 | -1.3 units on a scale | Standard Error 0.44 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 11 | -0.7 units on a scale | Standard Error 0.32 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 4 | -0.7 units on a scale | Standard Error 0.46 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 3 | -0.3 units on a scale | Standard Error 0.46 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 14 | -1.0 units on a scale | Standard Error 0.36 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 2 | -0.4 units on a scale | Standard Error 0.44 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Baseline | 1.6 units on a scale | Standard Error 0.34 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 12 | -0.7 units on a scale | Standard Error 0.45 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 13 | -0.7 units on a scale | Standard Error 0.44 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 6 | -0.8 units on a scale | Standard Error 0.33 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 9 | -1.0 units on a scale | Standard Error 0.26 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 15 | -0.9 units on a scale | Standard Error 0.38 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 10 | -0.9 units on a scale | Standard Error 0.32 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 7 | -0.8 units on a scale | Standard Error 0.43 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 5 | -0.3 units on a scale | Standard Error 0.3 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years | Change at Day 8 | -0.6 units on a scale | Standard Error 0.37 |
Comparison: Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1, 0.2]
Comparison: Change at Day 2, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1.1, 0.5]
Comparison: Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-0.5, 1.1]
Comparison: Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-0.6, 0.7]
Comparison: Change at Day 3, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1.5, 0.2]
Comparison: Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1, 0.5]
Comparison: Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.96% CI: [-1.1, 1.1]
Comparison: Change at Day 4, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-0.8, 0.8]
Comparison: Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-0.9, 0.8]
Comparison: Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.2, 0.3]
Comparison: Change at Day 5, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1.2, 0.4]
Comparison: Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-0.8, 1]
Comparison: Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.2, 0.6]
Comparison: Change at Day 6, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-0.9, 0.7]
Comparison: Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-0.5, 0.8]
Comparison: Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1, 0.9]
Comparison: Change at Day 7, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1, 0.7]
Comparison: Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1.2, 0.5]
Comparison: Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.3, 0.5]
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1.4, 0.2]
Comparison: Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-0.5, 0.8]
Comparison: Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.2, 0.6]
Comparison: Change at Day 9, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1.2, 0.4]
Comparison: Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1.2, 0.1]
Comparison: Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.3, 0.7]
Comparison: Change at Day 10, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1, 0.6]
Comparison: Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-0.8, 0.5]
Comparison: Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.6, 0.3]
Comparison: Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-0.4, 1]
Comparison: Change at Day 11, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1.2, 0.5]
Comparison: Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.9, 0]
Comparison: Change at Day 12, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1.5, 0.2]
Comparison: Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1, 0.5]
Comparison: Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.5, 0.4]
Comparison: Change at Day 13, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1.5, 0.2]
Comparison: Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1.1, 0.3]
Comparison: Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.4, 0.4]
Comparison: Change at Day 14, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1.1, 0.5]
Comparison: Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1, 0.6]
Comparison: Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-0.9, 0.5]
Comparison: Change at Day 15, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.95% CI: [-1.2, 0.5]
Comparison: Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1, 0.6]
Secondary
Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years
Observer reported itch severity NRS was used for participants \>=2 and \< 12 years of age to assess severity of itch (pruritus) due to AD at the target lesion. Parents/caregivers (of participants) were asked to rate participants' itch (i.e. scratching, rubbing) at the worst moment during past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable); higher scores represented more severe itch.
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Population: FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 4 | -0.5 units on a scale | Standard Error 0.51 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 13 | -2.1 units on a scale | Standard Error 0.55 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 7 | -2.0 units on a scale | Standard Error 0.4 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 6 | -1.9 units on a scale | Standard Error 0.45 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 5 | -1.4 units on a scale | Standard Error 0.48 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 2 | -0.5 units on a scale | Standard Error 0.3 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Baseline | 4.7 units on a scale | Standard Error 0.56 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 12 | -2.1 units on a scale | Standard Error 0.45 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 15 | -2.5 units on a scale | Standard Error 0.55 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 11 | -2.4 units on a scale | Standard Error 0.43 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 10 | -2.2 units on a scale | Standard Error 0.39 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 3 | -0.7 units on a scale | Standard Error 0.28 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 14 | -2.4 units on a scale | Standard Error 0.48 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 9 | -2.0 units on a scale | Standard Error 0.5 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 8 | -2.3 units on a scale | Standard Error 0.41 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 12 | -0.7 units on a scale | Standard Error 0.61 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Baseline | 5.0 units on a scale | Standard Error 0.5 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 2 | -0.4 units on a scale | Standard Error 0.31 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 3 | -0.5 units on a scale | Standard Error 0.35 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 4 | -0.4 units on a scale | Standard Error 0.38 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 5 | -0.1 units on a scale | Standard Error 0.6 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 6 | -0.9 units on a scale | Standard Error 0.43 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 7 | -0.9 units on a scale | Standard Error 0.45 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 8 | -1.3 units on a scale | Standard Error 0.36 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 9 | -0.8 units on a scale | Standard Error 0.42 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 10 | -0.9 units on a scale | Standard Error 0.42 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 11 | -1.1 units on a scale | Standard Error 0.45 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 13 | -1.0 units on a scale | Standard Error 0.5 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 14 | -1.2 units on a scale | Standard Error 0.49 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 15 | -1.3 units on a scale | Standard Error 0.45 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 15 | -4.3 units on a scale | Standard Error 0.63 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 3 | -1.6 units on a scale | Standard Error 0.47 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 14 | -4.3 units on a scale | Standard Error 0.56 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 9 | -3.4 units on a scale | Standard Error 0.61 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 10 | -3.9 units on a scale | Standard Error 0.62 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 2 | -0.7 units on a scale | Standard Error 0.4 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 6 | -2.7 units on a scale | Standard Error 0.62 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 11 | -3.5 units on a scale | Standard Error 0.69 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Baseline | 5.5 units on a scale | Standard Error 0.56 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 12 | -4.1 units on a scale | Standard Error 0.6 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 13 | -4.1 units on a scale | Standard Error 0.54 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 5 | -2.0 units on a scale | Standard Error 0.66 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 4 | -1.8 units on a scale | Standard Error 0.64 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 7 | -3.0 units on a scale | Standard Error 0.64 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 8 | -3.3 units on a scale | Standard Error 0.66 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 4 | -1.6 units on a scale | Standard Error 0.58 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 8 | -2.0 units on a scale | Standard Error 0.7 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 13 | -2.6 units on a scale | Standard Error 0.7 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 12 | -2.5 units on a scale | Standard Error 0.65 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 7 | -1.9 units on a scale | Standard Error 0.71 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 9 | -2.5 units on a scale | Standard Error 0.63 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 2 | -0.9 units on a scale | Standard Error 0.5 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 14 | -2.8 units on a scale | Standard Error 0.66 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 15 | -3.0 units on a scale | Standard Error 0.61 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 10 | -2.3 units on a scale | Standard Error 0.65 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 6 | -2.2 units on a scale | Standard Error 0.66 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 3 | -1.3 units on a scale | Standard Error 0.55 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 5 | -2.1 units on a scale | Standard Error 0.52 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Change at Day 11 | -2.4 units on a scale | Standard Error 0.66 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years | Baseline | 5.1 units on a scale | Standard Error 0.56 |
Comparison: Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-0.9, 0.7]
Comparison: Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-0.6, 1]
Comparison: Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-0.8, 1.2]
Comparison: Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-0.9, 0.5]
Comparison: Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.5, 1]
Comparison: Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1.6, 0.5]
Comparison: Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.1, 0.8]
Comparison: Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.5, 1.1]
Comparison: Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-2.4, 0.6]
Comparison: Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.2, -0.5]
Comparison: Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.3, 1.5]
Comparison: Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1.7, 1.2]
Comparison: Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2, 0]
Comparison: Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.4, 0.5]
Comparison: Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1.7, 0.8]
Comparison: Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2, -0.2]
Comparison: Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2, 0]
Comparison: Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.1, -0.1]
Comparison: Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1.9, 0.6]
Comparison: Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.4, -0.2]
Comparison: Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-1.9, 0.7]
Comparison: Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.3, -0.1]
Comparison: Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-1.9, 0.1]
Comparison: Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-2.4, 0.2]
Comparison: Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.4, -0.1]
Comparison: Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.5, -0.7]
Comparison: Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-2.6, -0.2]
Comparison: Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.4, -0.1]
Comparison: Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.2, -0.1]
Comparison: Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-2.2, 0.5]
Comparison: Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.9, 0]
Comparison: Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.4, -0.7]
Comparison: Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-2.9, -0.3]
Comparison: Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.5, 0.3]
Comparison: Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.4, -0.6]
Comparison: Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-3, -0.5]
Comparison: Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.5, -0.6]
Comparison: Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-2.8, -0.4]
Comparison: Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.5, 0.1]
Comparison: Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.4, -0.1]
Comparison: Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.95% CI: [-2.2, -0.3]
Comparison: Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.95% CI: [-2.8, -0.1]
Secondary
Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More
The severity of itch (pruritus) due to AD at the target lesion was assessed using the peak pruritus NRS. Participants aged 12 years or more, were asked to rate their itch severity at the worst moment during the past 24 hours on a scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores represented more severe itch.
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Population: FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 15 | -3.5 units on a scale | Standard Error 0.63 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Baseline | 5.3 units on a scale | Standard Error 0.59 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 5 | -2.6 units on a scale | Standard Error 0.54 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 2 | -1.3 units on a scale | Standard Error 0.45 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 14 | -3.3 units on a scale | Standard Error 0.64 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 13 | -3.4 units on a scale | Standard Error 0.62 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 12 | -3.5 units on a scale | Standard Error 0.6 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 10 | -3.3 units on a scale | Standard Error 0.53 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 7 | -2.9 units on a scale | Standard Error 0.5 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 8 | -3.2 units on a scale | Standard Error 0.49 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 3 | -1.7 units on a scale | Standard Error 0.51 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 6 | -2.8 units on a scale | Standard Error 0.48 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 9 | -3.2 units on a scale | Standard Error 0.51 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 4 | -2.5 units on a scale | Standard Error 0.53 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 11 | -3.5 units on a scale | Standard Error 0.54 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 3 | -1.1 units on a scale | Standard Error 0.49 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 5 | -1.5 units on a scale | Standard Error 0.46 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 8 | -2.0 units on a scale | Standard Error 0.56 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Baseline | 5.3 units on a scale | Standard Error 0.57 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 2 | -0.7 units on a scale | Standard Error 0.38 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 4 | -1.2 units on a scale | Standard Error 0.55 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 6 | -1.6 units on a scale | Standard Error 0.51 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 7 | -1.7 units on a scale | Standard Error 0.56 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 9 | -1.6 units on a scale | Standard Error 0.55 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 10 | -1.7 units on a scale | Standard Error 0.61 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 11 | -2.0 units on a scale | Standard Error 0.55 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 12 | -2.3 units on a scale | Standard Error 0.58 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 13 | -2.3 units on a scale | Standard Error 0.57 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 14 | -2.1 units on a scale | Standard Error 0.65 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 15 | -2.0 units on a scale | Standard Error 0.63 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 9 | -2.7 units on a scale | Standard Error 0.57 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 6 | -2.2 units on a scale | Standard Error 0.45 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 14 | -3.6 units on a scale | Standard Error 0.43 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 12 | -3.3 units on a scale | Standard Error 0.44 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 8 | -2.8 units on a scale | Standard Error 0.4 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Baseline | 5.1 units on a scale | Standard Error 0.47 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 7 | -2.5 units on a scale | Standard Error 0.39 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 2 | -0.6 units on a scale | Standard Error 0.2 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 13 | -3.5 units on a scale | Standard Error 0.45 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 3 | -1.4 units on a scale | Standard Error 0.3 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 10 | -3.0 units on a scale | Standard Error 0.44 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 15 | -3.7 units on a scale | Standard Error 0.47 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 5 | -2.6 units on a scale | Standard Error 0.37 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 4 | -2.0 units on a scale | Standard Error 0.32 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 11 | -3.1 units on a scale | Standard Error 0.41 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 4 | -1.2 units on a scale | Standard Error 0.44 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 8 | -2.2 units on a scale | Standard Error 0.48 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 14 | -2.6 units on a scale | Standard Error 0.47 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 6 | -1.9 units on a scale | Standard Error 0.46 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 7 | -2.1 units on a scale | Standard Error 0.45 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 13 | -2.4 units on a scale | Standard Error 0.46 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 9 | -2.3 units on a scale | Standard Error 0.46 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 2 | -0.5 units on a scale | Standard Error 0.37 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 11 | -2.3 units on a scale | Standard Error 0.49 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Baseline | 5.3 units on a scale | Standard Error 0.43 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 12 | -2.3 units on a scale | Standard Error 0.5 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 15 | -2.9 units on a scale | Standard Error 0.46 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 3 | -1.2 units on a scale | Standard Error 0.36 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 10 | -2.0 units on a scale | Standard Error 0.58 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More | Change at Day 5 | -1.8 units on a scale | Standard Error 0.4 |
Comparison: Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1, -0.2]
Comparison: Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-0.7, 0.5]
Comparison: Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.5, 1.7]
Comparison: Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.3, 0.1]
Comparison: Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-0.9, 0.4]
Comparison: Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.9, 1.3]
Comparison: Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2.1, -0.5]
Comparison: Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.5, -0.1]
Comparison: Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.6, 1.4]
Comparison: Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.9, -0.3]
Comparison: Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.5, -0.1]
Comparison: Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.95% CI: [-1.1, 1]
Comparison: Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2.1, -0.4]
Comparison: Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.1, 0.4]
Comparison: Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.6, 1.5]
Comparison: Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2.3, -0.1]
Comparison: Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1, 0.2]
Comparison: Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.6, 1.3]
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2, -0.3]
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.3, 0.1]
Comparison: Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.6, 1.2]
Comparison: Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2.4, -0.9]
Comparison: Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.5, 0.7]
Comparison: Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.95% CI: [-0.7, 1.6]
Comparison: Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2.3, -0.9]
Comparison: Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2.1, -0.1]
Comparison: Change at Day 10, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.95% CI: [-0.8, 1.2]
Comparison: Change at Day 11, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.7, 0]
Comparison: Change at Day 11, Intra-participant: MMRM included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2.3, -0.7]
Comparison: Change at Day 11, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.95% CI: [-0.7, 1.1]
Comparison: Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2, -0.5]
Comparison: Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2, 0]
Comparison: Change at Day 12, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.95% CI: [-0.9, 1.2]
Comparison: Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.8, -0.3]
Comparison: Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2, -0.1]
Comparison: Change at Day 13, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.95% CI: [-1.3, 0.9]
Comparison: Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.9, -0.5]
Comparison: Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-1.8, -0.1]
Comparison: Change at Day 14, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.95% CI: [-1.5, 0.7]
Comparison: Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.95% CI: [-2.2, -0.8]
Comparison: Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-1.5, 0]
Comparison: Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.95% CI: [-1.4, 0.8]
Secondary
Change From Baseline in Total Sign Score in Target Lesions at Day 15: Crisaborole Ointment 2% BID Versus Crisaborole Ointment 2% QD
Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity.
Time frame: Baseline, Day 15
Population: FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 15: Crisaborole Ointment 2% BID Versus Crisaborole Ointment 2% QD | -4.3 units on a scale |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 15: Crisaborole Ointment 2% BID Versus Crisaborole Ointment 2% QD | -4.9 units on a scale |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 15: Crisaborole Ointment 2% BID Versus Crisaborole Ointment 2% QD | -3.7 units on a scale |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 15: Crisaborole Ointment 2% BID Versus Crisaborole Ointment 2% QD | -4.5 units on a scale |
Comparison: Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.95% CI: [-2, 0.9]
Comparison: Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.95% CI: [-2.1, 0.4]
Secondary
Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle
Lesion TSS was an assessment of the target lesion severity, which was based on severity of 4 clinical signs erythema, induration/papulation, excoriation and lichenification. All of these 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). These ratings were added to create a total TSS score; ranging from 0 (none) to 12 (most severe), with higher score representing greater severity.
Time frame: Baseline, Day 8
Population: FAS included all participants who were randomized and received greater than or equal to 1 dose of investigational product. Here, Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Change at Day 8 | -3.9 units on a scale | Standard Error 0.49 |
| Crisaborole 2% QD: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.7 units on a scale | Standard Error 0.36 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Change at Day 8 | -2.0 units on a scale | Standard Error 0.4 |
| Vehicle QD: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.5 units on a scale | Standard Error 0.45 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Change at Day 8 | -3.7 units on a scale | Standard Error 0.53 |
| Crisaborole 2% BID: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.1 units on a scale | Standard Error 0.46 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Change at Day 8 | -2.3 units on a scale | Standard Error 0.35 |
| Vehicle BID: Age Group >=12 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.4 units on a scale | Standard Error 0.48 |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Change at Day 8 | -3.2 units on a scale | Standard Error 0.34 |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Baseline | 6.2 units on a scale | Standard Error 0.38 |
| Vehicle QD: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Baseline | 6.5 units on a scale | Standard Error 0.37 |
| Vehicle QD: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Change at Day 8 | -1.9 units on a scale | Standard Error 0.4 |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.1 units on a scale | Standard Error 0.45 |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Change at Day 8 | -3.7 units on a scale | Standard Error 0.46 |
| Vehicle BID: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Change at Day 8 | -2.0 units on a scale | Standard Error 0.39 |
| Vehicle BID: Age Group 2 to 11 Years | Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle | Baseline | 7.3 units on a scale | Standard Error 0.44 |
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-3.1, -0.7]
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-2.7, -0.2]
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-2.2, -0.2]
Comparison: Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.95% CI: [-2.8, -0.5]
Comparison: Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.95% CI: [-1.5, 1.3]
Comparison: Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.95% CI: [-1.2, 1]
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen
An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Day 1 up to 35 days after end of treatment (maximum up to Day 50)
Population: Safety analysis set included all participants receiving greater than or equal to 1 dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crisaborole 2% QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen | Participants With AEs | 6 Participants |
| Crisaborole 2% QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen | Participants With SAEs | 0 Participants |
| Vehicle QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen | Participants With SAEs | 0 Participants |
| Vehicle QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen | Participants With AEs | 6 Participants |
| Crisaborole 2% BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen | Participants With AEs | 2 Participants |
| Crisaborole 2% BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen | Participants With SAEs | 0 Participants |
| Vehicle BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen | Participants With AEs | 2 Participants |
| Vehicle BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen | Participants With SAEs | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term
An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state. For this outcome measure, treatment-emergent AEs occurred at each treated target lesion were summarized. MedDRA version 22.1 coding dictionary was used.
Time frame: Day 1 up to 35 days after end of treatment (maximum up to Day 50)
Population: Safety analysis set included all participants receiving greater than or equal to 1 dose of investigational product. Treatment emergent AEs and SAEs occurred in the target lesions were planned to be summarized by treatment in each regimen for each cohort and pooled cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crisaborole 2% QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 1 Participants |
| Crisaborole 2% QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 2 Participants |
| Crisaborole 2% QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 1 Participants |
| Crisaborole 2% QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 2 Participants |
| Crisaborole 2% QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 0 Participants |
| Vehicle QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 0 Participants |
| Vehicle QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 0 Participants |
| Vehicle QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 0 Participants |
| Vehicle QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 1 Participants |
| Vehicle QD: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 2 Participants |
| Crisaborole 2% BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 1 Participants |
| Crisaborole 2% BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 0 Participants |
| Crisaborole 2% BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 1 Participants |
| Crisaborole 2% BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 4 Participants |
| Crisaborole 2% BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 1 Participants |
| Vehicle BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 1 Participants |
| Vehicle BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 1 Participants |
| Vehicle BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 0 Participants |
| Vehicle BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 1 Participants |
| Vehicle BID: Age Group >=12 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 0 Participants |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 0 Participants |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 0 Participants |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 0 Participants |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 0 Participants |
| Crisaborole 2% QD: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 0 Participants |
| Vehicle QD: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 0 Participants |
| Vehicle QD: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 0 Participants |
| Vehicle QD: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 0 Participants |
| Vehicle QD: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 0 Participants |
| Vehicle QD: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 0 Participants |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 0 Participants |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 0 Participants |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 1 Participants |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 1 Participants |
| Crisaborole 2% BID: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 0 Participants |
| Vehicle BID: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 0 Participants |
| Vehicle BID: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 0 Participants |
| Vehicle BID: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 0 Participants |
| Vehicle BID: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 0 Participants |
| Vehicle BID: Age Group 2 to 11 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 0 Participants |
| Crisaborole 2% QD: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 2 Participants |
| Crisaborole 2% QD: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 1 Participants |
| Crisaborole 2% QD: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 0 Participants |
| Crisaborole 2% QD: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 1 Participants |
| Crisaborole 2% QD: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 2 Participants |
| Vehicle QD: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 0 Participants |
| Vehicle QD: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 0 Participants |
| Vehicle QD: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 0 Participants |
| Vehicle QD: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 2 Participants |
| Vehicle QD: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 1 Participants |
| Crisaborole 2% BID: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 2 Participants |
| Crisaborole 2% BID: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 4 Participants |
| Crisaborole 2% BID: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 1 Participants |
| Crisaborole 2% BID: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 2 Participants |
| Crisaborole 2% BID: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 0 Participants |
| Vehicle BID: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site folliculitis | 0 Participants |
| Vehicle BID: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site coldness | 1 Participants |
| Vehicle BID: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pruritus | 1 Participants |
| Vehicle BID: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site irritation | 1 Participants |
| Vehicle BID: All Age Group | Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term | Application site pain | 0 Participants |