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Trial record 1 of 1 for:    C3291027
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A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT04498403
Recruitment Status : Terminated (Terminated (This decision was made for business reasons only and is not related to any safety concerns regarding crisaborole.))
First Posted : August 4, 2020
Results First Posted : August 12, 2021
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Intervention Drug: Crisaborole 2%
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Hide Arm/Group Description Participants aged < 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug. Participants aged >= 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
Period Title: Overall Study
Started 30 10
Completed Follow up 30 10
Completed 0 0
Not Completed 30 10
Reason Not Completed
Adverse Event             1             0
Study Terminated By Sponsor             29             10
Arm/Group Title Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years Total
Hide Arm/Group Description Participants aged < 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug. Participants aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug. Total of all reporting groups
Overall Number of Baseline Participants 30 10 40
Hide Baseline Analysis Population Description
Safety population included all participants who took at least 1 dose of study drug. Participants who entered the first Off-Treatment cycle were included.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 10 participants 40 participants
9.3  (3.99) 31.8  (7.97) 15.0  (11.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 10 participants 40 participants
Female
15
  50.0%
4
  40.0%
19
  47.5%
Male
15
  50.0%
6
  60.0%
21
  52.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 10 participants 40 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
30
 100.0%
10
 100.0%
40
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 10 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
30
 100.0%
10
 100.0%
40
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who took at least 1 dose of study drug. Participants who entered the first Off-Treatment cycle were included.
Arm/Group Title Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Hide Arm/Group Description:
Participants aged < 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
Participants aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
Overall Number of Participants Analyzed 30 10
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
11
  36.7%
3
  30.0%
SAEs
0
   0.0%
0
   0.0%
Time Frame Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Hide Arm/Group Description Participants aged < 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug. Participants aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug.
All-Cause Mortality
Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   11/30 (36.67%)   3/10 (30.00%) 
General disorders     
Application site pain * 1  1/30 (3.33%)  0/10 (0.00%) 
Infections and infestations     
Bronchitis * 1  1/30 (3.33%)  0/10 (0.00%) 
Gastroenteritis * 1  0/30 (0.00%)  1/10 (10.00%) 
Molluscum contagiosum * 1  1/30 (3.33%)  0/10 (0.00%) 
Nasopharyngitis * 1  3/30 (10.00%)  0/10 (0.00%) 
Otitis media acute * 1  1/30 (3.33%)  0/10 (0.00%) 
Rhinitis * 1  1/30 (3.33%)  0/10 (0.00%) 
Injury, poisoning and procedural complications     
Wound * 1  0/30 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders     
Joint effusion * 1  0/30 (0.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  1/30 (3.33%)  0/10 (0.00%) 
Dermatitis atopic * 1  2/30 (6.67%)  0/10 (0.00%) 
Dermatitis contact * 1  1/30 (3.33%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA v23.1
*
Indicates events were collected by non-systematic assessment
Participants were planned to be followed up to Week 56, however due to early termination of the study, participants were followed up to only Week 12.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04498403    
Other Study ID Numbers: C3291027
First Submitted: July 31, 2020
First Posted: August 4, 2020
Results First Submitted: June 14, 2021
Results First Posted: August 12, 2021
Last Update Posted: August 12, 2021