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This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisaborole ointment 2% | Experimental |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole ointment 2% | Drug | Crisaborole ointment 2% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Skin Irritation Index | The skin irritation index is a common measure of skin irritation potential (safety criteria) of investigational product and derived using skin irritation scores. Individual skin irritation score ranges from 0-4, where 0 = no reaction, 0.5 = mild erythema, 1 = erythema, 2 = erythema with edema and papula, 3 = erythema with edema, papula and small water blister, 4 = large water blister, higher score indicates more skin irritation. For each investigational product, the skin irritation index was calculated as the sum of the maximum individual skin irritation scores divided by the number of evaluable participants and multiplied by 100, which ranged from 0 to 400; where, lower score indicated less skin irritation and higher score indicated more skin irritation. | Day 3 to 4 |
| Cohort 2: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 28 days after last dose of study drug (up to Day 36) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs. | Baseline up to Day 36 |
| Cohort 2: Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs included pulse rate and blood pressure. Clinical significance of vital signs was determined at the investigator's discretion. | Baseline up to end of treatment (Day 8) |
| Cohort 2: Number of Participants With Laboratory Tests Abnormalities | Laboratory tests abnormalities included: hematology (haemoglobin[Hb], haematocrit and erythrocytes<0.8*lower limit of normal[LLN]; erythrocyte mean corpuscular volume, erythrocyte mean corpuscular Hb and erythrocyte mean corpuscular Hb concentration <0.9*LLN and >1.1*upper limit of normal[ULN]; platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes/leukocytes[%], neutrophils/leukocytes[%] <0.8*LLN and >1.2*ULN; basophils/leukocytes[%], eosinophils/leukocytes[%], monocytes/leukocytes[% ]>1.2*ULN); clinical chemistry(bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase>3.0*ULN; protein and albumin<0.8*LLN and >1.2*ULN; urea nitrogen and creatinine >1.3*ULN; urate>1.2*ULN; sodium <0.95*LLN and >1.05*ULN; potassium, chloride and calcium <0.9*LLN and >1.1*ULN; fasting glucose <0.6*LLN and >1.5*ULN); and urinalysis (pH <4.5 and >8; glucose, ketones, protein, Hb, urobilinogen, bilirubin, nitrite and leukocyte esterase >=1). |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 28 days after last dose of study drug (up to Day 29) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs. |
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Inclusion Criteria:
Cohort 1
Cohort 2
Exclusion Criteria:
Cohort 1
Cohort 2
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OPHAC Hospital | Osaka | Osaka | 532-0003 | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Crisaborole Ointment 2% and Vehicle | Crisaborole ointment 2 percent (%) and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator. |
| FG001 | Cohort 2: Crisaborole Ointment 2% | Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is atopic dermatitis [AD]-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. |
| FG002 | Cohort 2: Vehicle | Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety analysis population included all participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Crisaborole Ointment 2% and Vehicle | Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cohort 1: Skin Irritation Index | The skin irritation index is a common measure of skin irritation potential (safety criteria) of investigational product and derived using skin irritation scores. Individual skin irritation score ranges from 0-4, where 0 = no reaction, 0.5 = mild erythema, 1 = erythema, 2 = erythema with edema and papula, 3 = erythema with edema, papula and small water blister, 4 = large water blister, higher score indicates more skin irritation. For each investigational product, the skin irritation index was calculated as the sum of the maximum individual skin irritation scores divided by the number of evaluable participants and multiplied by 100, which ranged from 0 to 400; where, lower score indicated less skin irritation and higher score indicated more skin irritation. | Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 2, as pre-specified in protocol. | Posted | Number | scores on a scale | Day 3 to 4 |
|
Baseline up to Day 29 for Cohort 1 and Day 36 for Cohort 2
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Crisaborole Ointment 2% and Vehicle | Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid oedema | Eye disorders | MedDRA v20.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2017 | Oct 26, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2017 | Oct 26, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Vehicle |
| Drug |
Vehicle |
|
| Baseline up to end of treatment (Day 8) |
| Cohort 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for clinically significant ECG abnormalities included: QT interval >=500 milliseconds (msec); QT interval corrected using the Fridericia's formula (QTcF) >=450 msec to <480 msec, >=480 msec and >=500 msec; increase from baseline in QTcF interval >=30 msec to <60 msec and >=60 msec. | Baseline up to end of treatment (Day 8) |
| Baseline up to Day 29 |
| Cohort 2: Maximum Observed Plasma Concentration (Cmax) of Crisaborole and Its Identified Main Oxidative Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8 |
| Cohort 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crisaborole and Its Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8 |
| Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Measurable Concentration (AUClast) of Crisaborole and Its Identified Main Oxidative Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8 |
| Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hours Post-Dose (AUC24) of Crisaborole and Its Identified Main Oxidative Metabolites (AN7602 and AN8323) | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8 |
| Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Tau (12 Hours Dosing Interval) (AUCtau) of Crisaborole and Its Identified Main Oxidative Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. AUC tau was defined as area under the plasma concentration-time curve from time 0 to time tau, the dosing interval, where tau =12 hours. | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8 |
| Cohort 2: Accumulation Ratio for Cmax (Rac [Cmax]) of Crisaborole and Its Identified Main Oxidative Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for Cmax (Rac, Cmax) was calculated as Cmax on Day 8 divided by Cmax on Day 1. Cmax was the maximum plasma concentration of Crisaborole and its identified main oxidative metabolites. | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8 |
| Cohort 2: Accumulation Ratio for AUCtau (Rac [AUCtau]) of Crisaborole and Its Identified Main Oxidative Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 8 divided by AUCtau on Day 1. Dosing interval = 12 hours. | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8 |
| BG001 | Cohort 2: Crisaborole Ointment 2% | Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. |
| BG002 | Cohort 2: Vehicle | Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| Cohort 1: Crisaborole Ointment 2% and Vehicle |
Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator. |
|
|
| Primary | Cohort 2: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 28 days after last dose of study drug (up to Day 36) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs. | Safety analysis population included all participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Day 36 |
|
|
|
| Primary | Cohort 2: Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs included pulse rate and blood pressure. Clinical significance of vital signs was determined at the investigator's discretion. | Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol. | Posted | Count of Participants | Participants | Baseline up to end of treatment (Day 8) |
|
|
|
| Primary | Cohort 2: Number of Participants With Laboratory Tests Abnormalities | Laboratory tests abnormalities included: hematology (haemoglobin[Hb], haematocrit and erythrocytes<0.8*lower limit of normal[LLN]; erythrocyte mean corpuscular volume, erythrocyte mean corpuscular Hb and erythrocyte mean corpuscular Hb concentration <0.9*LLN and >1.1*upper limit of normal[ULN]; platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes/leukocytes[%], neutrophils/leukocytes[%] <0.8*LLN and >1.2*ULN; basophils/leukocytes[%], eosinophils/leukocytes[%], monocytes/leukocytes[% ]>1.2*ULN); clinical chemistry(bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase>3.0*ULN; protein and albumin<0.8*LLN and >1.2*ULN; urea nitrogen and creatinine >1.3*ULN; urate>1.2*ULN; sodium <0.95*LLN and >1.05*ULN; potassium, chloride and calcium <0.9*LLN and >1.1*ULN; fasting glucose <0.6*LLN and >1.5*ULN); and urinalysis (pH <4.5 and >8; glucose, ketones, protein, Hb, urobilinogen, bilirubin, nitrite and leukocyte esterase >=1). | Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol. | Posted | Count of Participants | Participants | Baseline up to end of treatment (Day 8) |
|
|
|
| Primary | Cohort 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for clinically significant ECG abnormalities included: QT interval >=500 milliseconds (msec); QT interval corrected using the Fridericia's formula (QTcF) >=450 msec to <480 msec, >=480 msec and >=500 msec; increase from baseline in QTcF interval >=30 msec to <60 msec and >=60 msec. | Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol. | Posted | Count of Participants | Participants | Baseline up to end of treatment (Day 8) |
|
|
|
| Secondary | Cohort 1: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 28 days after last dose of study drug (up to Day 29) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs. | Safety analysis population included all participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Day 29 |
|
|
|
| Secondary | Cohort 2: Maximum Observed Plasma Concentration (Cmax) of Crisaborole and Its Identified Main Oxidative Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. | PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8 |
|
|
|
| Secondary | Cohort 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crisaborole and Its Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. | PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol. | Posted | Median | Full Range | hours | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8 |
|
|
|
| Secondary | Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Measurable Concentration (AUClast) of Crisaborole and Its Identified Main Oxidative Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. | PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanograms per milliliter(hr*ng/mL) | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8 |
|
|
|
| Secondary | Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hours Post-Dose (AUC24) of Crisaborole and Its Identified Main Oxidative Metabolites (AN7602 and AN8323) | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. | PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8 |
|
|
|
| Secondary | Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Tau (12 Hours Dosing Interval) (AUCtau) of Crisaborole and Its Identified Main Oxidative Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. AUC tau was defined as area under the plasma concentration-time curve from time 0 to time tau, the dosing interval, where tau =12 hours. | PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8 |
|
|
|
| Secondary | Cohort 2: Accumulation Ratio for Cmax (Rac [Cmax]) of Crisaborole and Its Identified Main Oxidative Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for Cmax (Rac, Cmax) was calculated as Cmax on Day 8 divided by Cmax on Day 1. Cmax was the maximum plasma concentration of Crisaborole and its identified main oxidative metabolites. | PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8 |
|
|
|
| Secondary | Cohort 2: Accumulation Ratio for AUCtau (Rac [AUCtau]) of Crisaborole and Its Identified Main Oxidative Metabolites | AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 8 divided by AUCtau on Day 1. Dosing interval = 12 hours. | PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Cohort 2: Crisaborole Ointment 2% | Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. | 0 | 10 | 0 | 10 | 9 | 10 |
| EG002 | Cohort 2: Vehicle | Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. | 0 | 2 | 0 | 2 | 2 | 2 |
| Application site coldness | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| AN7602: Day 8 |
|
| AN8323: Day 1 |
|
| AN8323: Day 8 |
|
| Title | Measurements |
|---|---|
|
| AN7602: Day 8 |
|
| AN8323: Day 1 |
|
| AN8323: Day 8 |
|
| Title | Measurements |
|---|---|
|
| AN7602: Day 8 |
|
| AN8323: Day 1 |
|
| AN8323: Day 8 |
|
| Title | Measurements |
|---|---|
|
| AN7602: Day 8 |
|
| AN8323: Day 1 |
|
| AN8323: Day 8 |
|
| Title | Measurements |
|---|---|
|
| AN7602: Day 8 |
|
| AN8323: Day 1 |
|
| AN8323: Day 8 |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|