Phase 4
N=137
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03356977 ↗Enrolled (actual)
137
Serious AEs
0.7%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions — 88; 1; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Crisaborole ointment 2% (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions |
88; 1; 15 | — |
| PRIMARY Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria |
0; 3 | — |
| PRIMARY Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria |
0; 3 | — |
| PRIMARY Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria |
3; 4; 8; 18 | — |
| PRIMARY Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria |
12; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria |
17; 4 | — |
| PRIMARY Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria |
— | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria |
0; 1; 0; 0; 10 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria |
105 | — |
Summary
This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
Eligibility Criteria
Inclusion Criteria
Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD
Exclusion Criteria
Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)
Data sourced from ClinicalTrials.gov (NCT03356977). 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.