NCT02118766.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, multicentre, parallel study Trial registration number: NCT02118766 Country: US Outpatient or hospital: not reported (presumed outpatient) Date trial conducted: March 2014 to April 2015 Duration of trial participation: 28 days Inclusion criteria: · Males or females 2 years and older · AD according to Hanifin and Rajk criteria · AD involvement ≥ 5% treatable% BSA (excluding the scalp) · ISGA score of mild (2) or moderate (3) · All female subjects of childbearing potential must use acceptable methods of contraception from the screening visit continuously until 30 days after stopping study drug. Exclusion criteria: · As determined by the study doctor, a medical history that may interfere with study objectives · Unstable AD or any consistent requirement for high potency topical corticosteroids · History of use of biologic therapy (including intravenous immunoglobulin) · Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD · Recent or current participation in another research study · Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study · Participation in a previous AN2728 clinical trial Additional design details: identifical study to NCT02118792 except the number recruited was slightly different |
| Participants | Total number randomised: 763 participants (507 to apply the intervention and 256 to apply the comparator) Age: 2 to 6 years n = 240, 7 to 11 years n = 228, 12 to 17 years n = 188, 18 or over n = 103 Sex: male n = 427, female n = 332 Ethnicity, duration of eczema: not reported Severity of eczema: mild‐to‐moderate Body site: except scalp and venous access area Number of withdrawals: 61; due to AE n = 9, withdrawal by subject n = 9, lost to follow‐up n = 9, withdrawal by parent/guardian n = 30, other n = 4 Notes: none |
| Interventions | Run‐in details: not reported Intervention: crisaborole 2% ointment twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle ointment 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 | · Percentage of participants who achieved treatment success based on ISGA · Treatment‐emergent AE and SAE · Clinically significant change in vital signs · Clinically significant change in laboratory values · Percentage of participants' ISGA score of clear (0) or almost clear (1) · Time to achieve treatment success based on ISGA · Change in signs of AD · Time to improvement in pruritus · Change in DLQI Score |
| Notes | Funding source: Pfizer Declarations of interest: not declared Original language of publication: English Other: none |