Trial record 1 of 1 for:
C3291027
A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
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 | |
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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 | |
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.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 30 participants | 10 participants | 40 participants | |
Female |
15 50.0%
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4 40.0%
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19 47.5%
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Male |
15 50.0%
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6 60.0%
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21 52.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 30 participants | 10 participants | 40 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
30 100.0%
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10 100.0%
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40 100.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 30 participants | 10 participants | 40 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
30 100.0%
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10 100.0%
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40 100.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
0 0.0%
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0 0.0%
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0 0.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
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
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
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 |