Lebwohl 1999.

Study characteristics
Methods	Trial design: multicentre, randomised, evaluator‐blind, parallel study Trial registration number: not reported Country: 10 centres in the USA Outpatient or hospital: assumed to be secondary care as the primary author is a dermatologist Date trial conducted: not reported Duration of trial participation: 22 days Inclusion criteria: · Aged 2 to 12 years · Moderate‐to‐severe AD · ≥ 15% total BSA involvement, excluding face and forehead, current exacerbation with a target area ≥ 20 cm2 · A six‐sign/symptom severity score ≥ 8 and ≤ 18 for the target area (erythema, induration/lichenification, scaling/crusting, exudation, excoriation, and pruritus graded from 0 = none to 3 = severe) · Severity ≥ 2 required for erythema and for 1 other sign Exclusion criteria: not reported Additional design details: none
Participants	Total number randomised: 219 participants (109 to apply the intervention and 110 to apply the comparator) Age: 2 to 12 years were eligible Sex, ethnicity, duration of eczema: not reported Severity of eczema: moderate‐to‐severe based on inclusion criteria Body site: not the face or forehead Number of withdrawals: 43 discontinued the trial early (from the safety population): · Clearance of signs and symptoms (18 in intervention group, 9 in the comparator group) · Treatment failure (0 in intervention group, 1 in comparator group) Notes: none
Interventions	Run‐in details: participants had failed to respond to at least 7 consecutive days of topical hydrocortisone treatment ending within a week of enrolment of this trial Intervention: mometasone furoate 0.1% cream used once daily for 21 days · Concurrent treatment: not reported · Other key information: none Comparator: hydrocortisone valerate 0.2% cream used twice daily for 21 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: no other therapies for AD were permitted. Notes: a target area (not face or forehead) of ≥ 20 cm2 was selected by the investigator for specific evaluation of the effects of treatment on disease signs and symptoms.
Outcomes	· Severity in the target area of erythema, induration/lichenification, scaling/crusting, exudation, excoriation, and pruritus graded on a scale from 0 = none to 3 = severe · IGA (cleared = 100% improvement; excellent = 75%–99%; good = 5 0% to 74%; fair = 25% to 49%; poor < 25%; exacerbation = flare‐up) · Treatment‐related atrophy · Application site reactions
Notes	Funding source: Schering Plough Inc. 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.