NCT04360187.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, multicentre, parallel study Trial registration number: NCT04360187 Country: China, Japan, Korea, Outpatient or hospital: outpatient clinic Date trial conducted: July 2020 to September 2021 Duration of trial participation: 28 days Inclusion criteria: · 2 years or older · AD according to the Hanifin and Rajka criteria · AD involvement of > 5% treatable BSA (excluding scalp) · ISGA score of mild (2) or moderate (3) (excluding scalp) · Female subjects of childbearing age with a negative pregnancy test at screening Exclusion criteria: · 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) · Unstable AD or any consistent requirement for high/strong potency or very high/very strong topical corticosteroids to manage AD signs and symptoms · History of angioedema or anaphylaxis · Significant active systemic or localised infection, including infected AD · Received any of the prohibited medications/therapies that may alter the course of AD without the required minimum washout · History of cancer within 5 years or having undergone treatment for cancer · Known sensitivity to the investigational product Additional design details: none |
| Participants | Total number randomised: 391 participants (260 to apply the intervention and 131 to apply the comparator) Age: 2 to 11 years n = 192: vehicle group n = 96, intervention group n = 123; 12 to 17 years n = 40: vehicle group n = 15, intervention group n = 25; > 18 years n = 159: vehicle group n = 47, intervention group n = 112 Sex: male n = 205: vehicle group n = 67, intervention group n = 138; female n = 186: vehicle group n = 64, intervention group n = 122 Ethnicity: Asian Duration of eczema: not reported Severity of eczema: ISGA score of mild (2) or moderate (3) Body site: all treatable AD‐involved areas (excluding the scalp) Number of withdrawals: n = 38: vehicle group n = 23, intervention group n = 15 Notes: none |
| Interventions | Run‐in details: participation in other studies involving investigational drugs within 30 days prior to study entry and/or during study participation Intervention: crisaborole 2% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · EASI · Treatment‐emergent (TE)AE/SAE · Clinical laboratory parameters · Significant changes in vital signs · ISGA · Peak pruritus NRS · Percent BSA · EASI · Itch severity scale · DLQI · CDLQI · The Infants' Dermatitis Quality of Life Index (IDQOL) · POEM |
| Notes | Funding source: Pfizer Declarations of interest: not declared Original language of publication: English Other: none |