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| ID | Type | Description | Link |
|---|---|---|---|
| CARE 1 | Other Identifier | Alias Study Number |
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This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
Approximately 125 subjects will be enrolled. Subjects must have mild-to-moderate AD involving at least 5% treatable %BSA assessed on Baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD-involved, excluding the scalp.
In addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for PK assessment. These subjects must have moderate AD and a minimum of 35% treatable %BSA, excluding the scalp, and must complete all PK assessments to be included in the PK analysis. Of these subjects, at least 3 subjects who are less than 9 months of age will be enrolled. Subjects discontinuing for reasons other than treatment emergent adverse event ( TEAE) may be replaced at the discretion of the sponsor to ensure 16 subjects complete the PK assessments. Only selected study sites will participate in the PK assessment.
Scheduled study visits/telephone contacts for all subjects will occur at Screening (up to 28 days prior to Baseline/Day 1), Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination), Day 36, and Day 57 (end of study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisaborole ointment 2% | Experimental | Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole ointment 2% | Drug | Applied BID |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions | An AE was any untoward medical occurrence in a participant who received investigational product 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; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Site reactions are reactions which occurred in participants at the site of application of investigational product. | Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days) |
| Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria | Height of participants was measured in terms of centimeter (cm). The pre-defined criteria for measuring the height was less than (<) 55 cm and greater than (>) 92.5 cm. | Baseline (Day 1) up to Day 29 (end of treatment) |
| Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria | Weight of participants was measured in terms of kilogram (kg). The pre-defined criteria of measuring the weight of participants was less than equal to (<=) 4.5 kg and >15 kg. | Baseline (Day 1) up to Day 29 (end of treatment) |
| Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria | Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) of participants was measured in terms of millimeters of mercury (mmHg). The clinically significant pre-defined criteria were, SBP: change of greater than equal to (>=) 30 mmHg increase from baseline (IFB) and SBP change of >= 30 mmHg decrease from baseline (DFB); DBP: change of >=20 mmHg IFB and DBP change of >=20 mmHg DFB. |
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Inclusion Criteria:
Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD
Exclusion Criteria:
Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Rady Children's Hospital - San Diego/University of California, San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32212104 | Derived | Schlessinger J, Shepard JS, Gower R, Su JC, Lynde C, Cha A, Ports WC, Purohit V, Takiya L, Werth JL, Zang C, Vlahos B; CARE 1 Investigators. Safety, Effectiveness, and Pharmacokinetics of Crisaborole in Infants Aged 3 to < 24 Months with Mild-to-Moderate Atopic Dermatitis: A Phase IV Open-Label Study (CrisADe CARE 1). Am J Clin Dermatol. 2020 Apr;21(2):275-284. doi: 10.1007/s40257-020-00510-6. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crisaborole Topical Ointment, 2 Percent | Participants with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent on treatable AD lesions, twice daily from Day 1 to Day 29. Treatable AD lesions were identified at Baseline (Day 1) by investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2018 | Sep 20, 2019 |
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| Baseline (Day 1) up to Day 29 (end of treatment) |
| Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria | Pulse rate of participants was measured in terms of beats per minute (bpm). The pre-defined criteria of measuring the pulse rate of participants was <90 bpm and >180 bpm. | Baseline (Day 1) up to Day 29 (end of treatment) |
| Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria | Respiratory rate was measured in terms of number of breaths per minute. The pre-defined criteria of measuring the respiratory rate of participants was < 22 breaths per min and > 53 breaths per min. | Baseline (Day 1) up to Day 29 (end of treatment) |
| Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria | Body temperature of participants was measured in degree Celsius. The normal body temperature value was >= 39 degree Celsius. | Baseline (Day 1) up to Day 29 (end of treatment) |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria | ECG of participants was measured in terms of millisecond (msec). ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Fridericia's formula (QTcF). ECG values meeting pre-defined criteria were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) > 30 msec. IFB stands for increase from baseline. | Baseline (Day 1) up to Day 29 (end of treatment) |
| Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria | Criteria: hematology: hemoglobin, hematocrit, erythrocytes < 0.8*lower limit of normal (LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN), leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, bicarbonate <0.9* LLN >1.1* ULN, glucose <0.6*LLN >1.5*ULN. | Baseline (Day 1) up to Day 29 (end of treatment) |
| San Diego |
| California |
| 92123 |
| United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| IMMUNOe Research Centers | Thornton | Colorado | 80233 | United States |
| Baumann Cosmetic and Research Institute | Miami | Florida | 33137 | United States |
| DS Research | Louisville | Kentucky | 40241 | United States |
| Craig A. Spiegel, M.D. | Bridgeton | Missouri | 63044 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Ohio Pediatric Research Association, Inc. | Dayton | Ohio | 45414 | United States |
| Oklahoma State University - Center for Health Sciences | Tulsa | Oklahoma | 74127 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| Jordan Valley Dermatology Center | West Jordan | Utah | 84088 | United States |
| Timber Lane Allergy & Asthma Research, LLC | South Burlington | Vermont | 05403 | United States |
| PI-Coor Clinical Research, LLC | Burke | Virginia | 22015 | United States |
| Pediatric Associates of Charlottesville, PLC | Charlottesville | Virginia | 22902 | United States |
| Pediatric Research of Charlottesville, LLC (Regulatory Only) | Charlottesville | Virginia | 22902 | United States |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| Australian Clinical Research Network Pty Ltd | Maroubra | New South Wales | 2035 | Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Veracity Clinical Research | Woolloongabba | Queensland | 4102 | Australia |
| Eastern Health | Box Hill | Victoria | 3128 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| The Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| Stollery Children's Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included any participant who received at least 1 dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Crisaborole Topical Ointment, 2 Percent | Participants with mild to moderate AD received crisaborole ointment, 2 percent on treatable AD lesions, twice daily from Day 1 to Day 29. Treatable AD lesions were identified at Baseline (Day 1) by investigator. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions | An AE was any untoward medical occurrence in a participant who received investigational product 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; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Site reactions are reactions which occurred in participants at the site of application of investigational product. | Safety analysis set included any participant who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days) |
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| Primary | Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria | Height of participants was measured in terms of centimeter (cm). The pre-defined criteria for measuring the height was less than (<) 55 cm and greater than (>) 92.5 cm. | Safety analysis set included any participant who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Day 29 (end of treatment) |
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| Primary | Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria | Weight of participants was measured in terms of kilogram (kg). The pre-defined criteria of measuring the weight of participants was less than equal to (<=) 4.5 kg and >15 kg. | Safety analysis set included any participant who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Day 29 (end of treatment) |
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| Primary | Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria | Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) of participants was measured in terms of millimeters of mercury (mmHg). The clinically significant pre-defined criteria were, SBP: change of greater than equal to (>=) 30 mmHg increase from baseline (IFB) and SBP change of >= 30 mmHg decrease from baseline (DFB); DBP: change of >=20 mmHg IFB and DBP change of >=20 mmHg DFB. | Safety analysis set included any participant who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable for specific rows. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Day 29 (end of treatment) |
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| Primary | Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria | Pulse rate of participants was measured in terms of beats per minute (bpm). The pre-defined criteria of measuring the pulse rate of participants was <90 bpm and >180 bpm. | Safety analysis set included any participant who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Day 29 (end of treatment) |
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| Primary | Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria | Respiratory rate was measured in terms of number of breaths per minute. The pre-defined criteria of measuring the respiratory rate of participants was < 22 breaths per min and > 53 breaths per min. | Safety analysis set included any participant who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Day 29 (end of treatment) |
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| Primary | Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria | Body temperature of participants was measured in degree Celsius. The normal body temperature value was >= 39 degree Celsius. | Safety analysis set included any participant who received at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Day 29 (end of treatment) |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria | ECG of participants was measured in terms of millisecond (msec). ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Fridericia's formula (QTcF). ECG values meeting pre-defined criteria were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) > 30 msec. IFB stands for increase from baseline. | Safety analysis set included any participant who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Day 29 (end of treatment) |
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| Primary | Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria | Criteria: hematology: hemoglobin, hematocrit, erythrocytes < 0.8*lower limit of normal (LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN), leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, bicarbonate <0.9* LLN >1.1* ULN, glucose <0.6*LLN >1.5*ULN. | Safety analysis set included any participant who received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1) up to Day 29 (end of treatment) |
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Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
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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 | Crisaborole Topical Ointment, 2 Percent | Participants with mild to moderate AD received crisaborole ointment, 2 percent on treatable AD lesions, twice daily from Day 1 to Day 29. Treatable AD lesions were identified at Baseline (Day 1) by investigator. | 0 | 137 | 1 | 137 | 41 | 137 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile convulsion | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v21.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2019 | Sep 20, 2019 | SAP_001.pdf |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C543085 | crisaborole |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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