A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT03260595 |
Recruitment Status :
Completed
First Posted : August 24, 2017
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
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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: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Basic Science |
Conditions |
Healthy Atopic Dermatitis |
Interventions |
Drug: Crisaborole ointment 2% Drug: Vehicle |
Enrollment | 32 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Cohort 1: Crisaborole Ointment 2% and Vehicle | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle |
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Arm/Group Description | 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. | 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. | 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. |
Period Title: Overall Study | |||
Started | 20 | 10 | 2 |
Completed | 20 | 10 | 2 |
Not Completed | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Cohort 1: Crisaborole Ointment 2% and Vehicle | Cohort 2: Crisaborole Ointment 2% | Cohort 2: Vehicle | Total | |
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Arm/Group Description | 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. | 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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 20 | 10 | 2 | 32 | |
Baseline Analysis Population Description |
Safety analysis population included all participants who received at least one dose of study medication.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 20 participants | 10 participants | 2 participants | 32 participants | |
26.2 (5.66) | 35.0 (11.28) | 23.5 (4.95) | 28.8 (8.72) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 20 participants | 10 participants | 2 participants | 32 participants | |
Female |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Male |
20 100.0%
|
10 100.0%
|
2 100.0%
|
32 100.0%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 20 participants | 10 participants | 2 participants | 32 participants | |
Hispanic or Latino |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Not Hispanic or Latino |
20 100.0%
|
10 100.0%
|
2 100.0%
|
32 100.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 20 participants | 10 participants | 2 participants | 32 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
20 100.0%
|
10 100.0%
|
2 100.0%
|
32 100.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
White |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
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: | NCT03260595 |
Other Study ID Numbers: |
C3291029 |
First Submitted: | August 9, 2017 |
First Posted: | August 24, 2017 |
Results First Submitted: | October 26, 2018 |
Results First Posted: | March 1, 2019 |
Last Update Posted: | March 1, 2019 |