Salava 2021.

Study characteristics
Methods	Trial design: randomised, single‐centre, parallel study Trial registration number: not reported Country: Finland Outpatient or hospital: paediatric unit of Helsinki University Hospital, Skin and Allergy Hospital, Helsinki Date trial conducted: not reported Duration of trial participation: one week washout period with a 36‐month follow‐up Inclusion criteria: · Aged 1 to 3 years · Moderate‐to‐severe AD according to Rajka and Langeland severity score 4.5 to 7.5 (moderate) or 8 to 9 (severe) Exclusion criteria: · Recurrent infections e.g. otitis, pneumonia and skin infections · Signs of immune deficiency or chronic diseases · Continuous medications including inhaled corticosteroids Additional design details: none
Participants	Total number randomised: 152 participants (75 to apply the intervention and 77 to apply the comparator) Age: mean 1.43 years; intervention group mean 1.44 years; comparator group: mean 1.42 years Sex: male n = 79, female n = 73; intervention group male n = 44, female n = 31; comparator group: male n = 35, female n = 34 Ethnicity, duration of eczema: not reported Severity of eczema: according to Rajka and Langeland criteria: moderate n = 82, severe eczema n = 70; intervention group: moderate n = 41, severe eczema n = 34; comparator group: moderate n = 41, severe eczema n = 36 Body site: not reported Number of withdrawals: 27: intervention group n = 12,; comparator group n = 15, to quote: "any withdrawals were mostly due to noncompliance or to the family moving away." Notes: none
Interventions	Run‐in details: to quote: "1‐week washout period" Intervention: hydrocortisone acetate 1% cream twice daily for 3 to 7 days or until clearance, then twice‐weekly · Concurrent treatment: not reported · Other key information: treatment could be escalated to hydrocortisone butyrate 0.1% cream if needed Comparator: tacrolimus 0.03% ointment twice daily for 3 to 7 days or until clearance, then twice‐weekly · Concurrent treatment: not reported · Other key information: treatment could be escalated to tacrolimus 0.1% ointment if needed Concurrent treatments received alongside both intervention and comparator: not reported Notes: none
Outcomes	· Safety including infection rate and growth parameters (height and weight) · EASI · Vaccination responses and other safety relevant laboratory values · Skin‐related and non‐skin‐related infections were noted retrospectively through information from parents/caregivers. Type and severity could not be verified. (assessed at baseline, week 1, months 1, 3, 6, 9 and 12, and then 6 monthly up to 36 months)
Notes	Funding source: to quote: "The work was supported by: The Pediatric Research Foundation, Helsinki University Hospital Research Fund, Sigrid Juselius Foundation, Päivikki and Sakari Sohlberg Foundation, Finnish Dermatological Society, Allergy Research Foundation, Väinö and Laina Kivi Foundation, Orion Research Foundation, Ida Montin Foundation, Orion Pharma Finland and Astellas Pharma. The sponsors had no influence on the study". Declarations of interest: not declared Original language of publication: English Other: this study has previously been extracted by this group; some content is reproduced from Lax 2022.