Phase 3
Completed N=391
Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
Source: ClinicalTrials.gov NCT04360187 ↗Enrolled (actual)
391
Serious AEs
0.5%
Results posted
May 2022
Primary outcomePrimary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29 — -42.79; -59.92 Percent Change — p=0.0002
◆ Published Evidence
Emerging
3citations · ~2 / year
Efficacy and Safety of Crisaborole Ointment 2% in Chinese Patients Aged ≥ 2 Years with Mild to Moderate Atopic Dermatitis.
Summary
This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).
Linked Publications
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Efficacy and Safety of Crisaborole Ointment 2% in Chinese Patients Aged ≥ 2 Years with Mild to Moderate Atopic Dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29 |
-42.79; -59.92 | 0.0002 sig |
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
44.3; 46.2; 0.8; 0.4; 1.5; 0 | — |
| PRIMARY Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters |
1.6; 0; 0; 0.4; 0.8; 0 | — |
| PRIMARY Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs |
7.8; 7.3; 2.3; 3.5; 3.9; 3.1 | — |
| SECONDARY Percentage of Participants Achieving Improvement in Investigator's Static Global Assessment (ISGA) at Day 29 |
28.5; 41.4 | 0.0124 sig |
| SECONDARY Percentage of Participants Achieving Success in ISGA at Day 29 |
15.9; 27.6 | 0.0078 sig |
| SECONDARY Change From Baseline in Peak Pruritus Numeric Rating Scale (NRS) at Week 4-for Participants ≥12 Years |
-0.79; -1.58 | 0.0009 sig |
| SECONDARY Percentage of Participants Achieving Success in ISGA Over Time |
0.0; 4.8; 4.9; 11.6; 10.8; 18.1 | — |
| SECONDARY Percentage of Participants Achieving Improvement in ISGA Over Time |
7.8; 16.8; 18.3; 25.6; 25.1; 32.3 | — |
| SECONDARY Percent Change From Baseline in EASI Total Score Over Time |
-21.43; -36.65; -37.15; -49.65; -42.92; -55.05 | — |
| SECONDARY Change From Baseline in Percent Body Surface Area (%BSA) Over Time |
-1.75; -5.12; -3.31; -7.60; -4.38; -8.72 | — |
| SECONDARY Percentage of Participants Achieving EASI-50 Over Time |
18.5; 37.1; 32.7; 58.9; 42.2; 66.4 | — |
| SECONDARY Percentage of Participants Achieving EASI-75 Over Time |
6.1; 11.2; 15.4; 26.3; 26.3; 38.2 | — |
| SECONDARY Change From Baseline in Peak Pruritus NRS Over Time-for Participants ≥12 Years |
-0.38; -0.94; -0.53; -1.26; -0.64; -1.41 | — |
| SECONDARY Change From Baseline in Patient Reported Itch Severity Scale Over Time-for Participants ≥6 Years and <12 Years |
-0.26; -0.51; -0.22; -0.70; -0.37; -0.78 | — |
| SECONDARY Change From Baseline in Observer Reported Itch Severity Scale Over Time-for Participants <6 Years |
-0.31; -1.03; -0.73; -1.68; -0.96; -1.79 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time |
-1.1; -1.7; -1.5; -1.8 | — |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score Over Time |
-1.3; -3.6; -1.8; -3.9 | — |
| SECONDARY Change From Infants' Dermatitis Quality of Life Index (IDQOL) Total Score Over Time |
-1.3; -3.0; -0.7; -4.3 | — |
| SECONDARY Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score Over Time |
-0.5; -2.4; -2.1; -3.0 | — |
| SECONDARY Change From Baseline in Patient-Oriented Eczema Measure (POEM) Over Time in Participants ≥12 Years |
-1.8; -5.4; -3.3; -5.7 | — |
| SECONDARY Change From Baseline in POEM Over Time in Participants ≥2 Years and <12 Years |
-2.5; -6.7; -3.8; -7.7 | — |
| SECONDARY Change From Baseline in Weekly Average of Patient Global Impression of Severity (PGIS) Score |
-0.24; -0.43; -0.26; -0.60; -0.38; -0.66 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Score |
3.3; 2.6; 3.2; 2.6; 3.0; 2.6 | — |
| SECONDARY Change From Baseline in Weekly Average of Observer Reported Global Impression of Severity (OGIS) Score |
-0.12; -0.62; -0.27; -0.93; -0.41; -1.03 | — |
| SECONDARY Observer Reported Global Impression of Change (OGIC) Score |
3.0; 2.3; 3.0; 2.3; 2.9; 2.4 | — |
Eligibility Criteria
Inclusion Criteria
- Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA.
Exclusion Criteria
- Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant physical examination finding at Screening that in the PI's or designee's opinion may interfere with study objectives.
- Has participated in a previous crisaborole clinical study.
Data sourced from ClinicalTrials.gov (NCT04360187) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.