Trial Outcomes & Findings for A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis (NCT NCT03356977)
NCT ID: NCT03356977
Last Updated: 2019-10-10
Results Overview
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.
COMPLETED
PHASE4
137 participants
Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
2019-10-10
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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137
|
|
Overall Study
COMPLETED
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132
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Lost to Follow-up
|
3
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Overall Study
Withdrawal by parent/guardian
|
2
|
Baseline Characteristics
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=137 Participants
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.
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|---|---|
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Age, Continuous
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13.6 months
STANDARD_DEVIATION 6.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)Population: Safety analysis set included any participant who received at least 1 dose of investigational product.
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.
Outcome measures
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=137 Participants
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.
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|---|---|
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Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
AEs
|
88 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
SAEs
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
Application site Reactions
|
15 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 29 (end of treatment)Population: 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.
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.
Outcome measures
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=134 Participants
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.
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|---|---|
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Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria
< 55 cm
|
0 Participants
|
|
Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria
> 92.5 cm
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 29 (end of treatment)Population: 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.
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.
Outcome measures
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=135 Participants
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.
|
|---|---|
|
Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria
<= 4.5 kg
|
0 Participants
|
|
Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria
> 15 kg
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 29 (end of treatment)Population: 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.
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.
Outcome measures
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=136 Participants
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.
|
|---|---|
|
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
DSBP: change of >= 20 mmHg DFB
|
18 Participants
|
|
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
SBP:change of>=30 mmHg IFB
|
3 Participants
|
|
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
SBP:change of>=30 mmHg DFB
|
4 Participants
|
|
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
DSBP: change of >= 20 mmHg IFB
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 29 (end of treatment)Population: Safety analysis set included any participant who received at least 1 dose of investigational product.
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.
Outcome measures
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=137 Participants
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.
|
|---|---|
|
Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria
<90 bpm
|
12 Participants
|
|
Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria
>180 bpm
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 29 (end of treatment)Population: Safety analysis set included any participant who received at least 1 dose of investigational product.
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.
Outcome measures
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=137 Participants
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.
|
|---|---|
|
Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria
< 22 breaths per minute
|
17 Participants
|
|
Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria
> 53 breaths per minute
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 29 (end of treatment)Population: Safety analysis set included any participant who received at least 1 dose of investigational product.
Body temperature of participants was measured in degree Celsius. The normal body temperature value was \>= 39 degree Celsius.
Outcome measures
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=137 Participants
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.
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|---|---|
|
Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 29 (end of treatment)Population: 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.
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.
Outcome measures
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=135 Participants
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.
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|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
PR Interval: <= 200 msec and >=50% IFB
|
1 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
QRS Duration: >= 100 msec and >= 25% IFB
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
QTcF Interval: >30 msec
|
10 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
PR Interval: > 200 msec and >=25% IFB
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
QRS Duration: < 100 msec and >= 50% IFB
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 29 (end of treatment)Population: 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.
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.
Outcome measures
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=122 Participants
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.
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|---|---|
|
Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria
|
105 Participants
|
Adverse Events
Crisaborole Topical Ointment, 2 Percent
Serious adverse events
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=137 participants at risk
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.
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|---|---|
|
Nervous system disorders
Febrile convulsion
|
0.73%
1/137 • 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.
|
Other adverse events
| Measure |
Crisaborole Topical Ointment, 2 Percent
n=137 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
10/137 • 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.
|
|
General disorders
Pyrexia
|
9.5%
13/137 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
10/137 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
7/137 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
6.6%
9/137 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
6.6%
9/137 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER