Phase 2
Completed N=81
Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis
Source: ClinicalTrials.gov NCT03954158 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle — 7.7; 7.5; 7.1; 7.4 units on a scale — p=0.0071
Summary
This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older, cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle |
7.7; 7.5; 7.1; 7.4; 6.2; 6.5 | 0.0071 sig |
| SECONDARY Change From Baseline in Total Sign Score in Target Lesions at Day 15: Crisaborole Ointment 2% BID Versus Crisaborole Ointment 2% QD |
-4.3; -4.9; -3.7; -4.5 | — |
| SECONDARY Change From Baseline in Total Sign Score in Target Lesions at Day 8: Crisaborole Ointment 2% Versus Vehicle |
7.7; 7.5; 7.1; 7.4; 6.2; 6.5 | — |
| SECONDARY Change From Baseline in Investigator's Static Global Assessment (ISGA) Score in Target Lesions at Day 8 and Day 15 |
3.0; 3.0; 3.0; 3.0; 3.0; 3.0 | — |
| SECONDARY Change From Baseline in Peak Pruritus Numerical Rating Scale (NRS) in Target Lesions up to Day 15 in Participants Aged 12 Years or More |
5.3; 5.3; 5.1; 5.3; -1.3; -0.7 | — |
| SECONDARY Change From Baseline in Itch Severity Scale in Target Lesions up to Day 15 in Participants Aged Between 6 to 11 Years |
1.6; 1.8; 1.9; 1.6; -0.7; -0.3 | — |
| SECONDARY Change From Baseline in Observer Reported Itch Severity Numerical Rating Scale in Target Lesions up to Day 15 in Participants Aged Between 2 to 11 Years |
4.7; 5.0; 5.5; 5.1; -0.5; -0.4 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Target Lesions Per Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) by Treatment Regimen |
6; 6; 2; 2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female participants ages; Cohort 1: 12 years and older at the time of consent. Cohort 2: 2 years to under 12 years old at the time of consent.
- Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria and has at least 6 months history prior to screening and has been clinically stable for more than 1 month
- Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals and groin area
- Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3) on Day 1.
Exclusion Criteria
- Has other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Participants had previous treatment with any topical or systemic PDE-4 inhibitor.
Data sourced from ClinicalTrials.gov (NCT03954158). 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.