NCT03645057.

Study characteristics
Methods	Trial design: randomised, single‐centre, parallel study Trial registration number: NCT03645057 Country: USA Outpatient or hospital: outpatient (assumed) Date trial conducted: February 2019 to August 2021 Duration of trial participation: 12 weeks Inclusion criteria: · Male and female aged between 2 and 15 years · ≤ moderate AD or eczema (ISGA 2 or 3 and ≥ 3% BSA, excluding scalp) · If taking or prescribed antihistamines, must be on stable dose of antihistamines. If taking topical steroids, must be on stable dose of topical steroid. If taking tacroliumus, crisaborole, or other topical steroid‐sparring medications are eligible for this study if he/she agrees to a two‐week “washout period” prior to starting study procedures. If taking systemic anti‐inflammatory therapy, must be on a stable dose of the systemic anti‐inflammatory medication for at least six weeks prior to enrolment, and it must be anticipated that this dose would not change during participation in this study, unless deemed medically necessary. Exclusion criteria: · Paediatric participant < 2 years old or > 15 years old · A diagnosis of another skin disease · No caregiver participation Additional design details: none
Participants	Total number randomised: 46 participants (23 to apply the intervention and 23 to apply the comparator) Age: 2 to 15 years old Sex: male crisaborole group n = 8; tacrolimus group n = 12; female crisaborole group n = 15, tacrolimus group n = 11 Ethnicity: Hispanic/Latino n = 6, Asian n = 3, black/African‐American n = 11, white n = 32, more than one race n = 1 Duration of eczema: not reported Severity of eczema: moderate or less severity Body site: area score is recorded for four regions of the body (head and neck, trunk including genital area, upper limbs, and lower limbs including buttocks) Number of withdrawals: one dyad (i.e. 1 child patient with 1 caregiver) was lost to follow‐up after randomisation (crisaborole arm) but before baseline assessment. Notes: none
Interventions	Run‐in details: two week washout of tacrolimus or crisaborole, or other steroid‐sparring medication prior to randomisation Intervention: crisaborole 2% ointment used twice daily for 84 days · Concurrent treatment: not reported · Other key information: none Comparator: tacrolimus 0.03% ointment used twice daily for 84 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none
Outcomes	· PROMIS Paediatric Itch Short‐Form, Pain Interference‐Pediatric · CDLQI · Children's Sleep Habits Questionnaire · EASI
Notes	Funding source: not reported (sponser University of Rochester) Declarations of interest: not declared Original language of publication: English Other: There were 47 patient/caregiver dyads (i.e. 94 participants total = 47 child patients with 47 caregivers). The assessments extracted were from the children (n = 47) enroled in the study.