Vernon 1991.

Study characteristics
Methods	Trial design: randomised, blind, multicentre, parallel study Trial registration number: none Country: US Outpatient or hospital: two settings, to quote: "Departments of Dermatology and Pediatrics, University of Rochester School of Medicine and Dentistry, and the Departments of Dermatology and Pediatrics, University of Colorado School of Medicine", assumed from the authors' affiliations Date trial conducted: not reported Duration of trial participation: seven weeks: 6 weeks treatment, followed by assessment 1 week after the end of treatment Inclusion criteria: · Children with AD aged between 6 months and 12 years · Initial BSA involved ≥ 15% · Target area scoring ≥ 8/15 in severity based on the sum of 5 signs and symptoms: erythema, lichenification, skin surface disruption i.e. crusting and scaling, excoriation, and pruritus, each scored between 0 = none and 3 = severe. The erythema score was required to be ≥ 2. · Acceptable values for blood cell count, blood electrolytes, glucose, liver enzymes, triglycerides, cholesterol, and plasma cortisol Exclusion criteria: · Receiving systemic steroids within 28 days of enrolment · Using TCS within 7 days of enrolment Additional design details: at the end of the third week, participants whose dermatitis had cleared or shown no improvement were dropped from the trial.
Participants	Total number randomised: 48 participants (24 to apply the intervention and 24 to apply the comparator) Age: 7 months to < 2 years n = 12, 2 to 6 years n = 22, > 6 years to 12 years n = 14 Sex, ethnicity, duration of eczema: not reported Severity of eczema: mean target area score 11.3 in the mometasone group, 11.7 in the HC group based on the sum of 5 signs and symptoms: erythema, lichenification, skin surface disruption, excoriation, and pruritus Body site: 39/48 had sites on extremities. Number of withdrawals: 15 participants in each group completed the trial early, owing to clearing of their dermatitis (median duration 3 weeks). Five in the HC group discontinued: lack of response (3), flare‐up of asthma and need for steroids (1) and lost to follow‐up (1); mometasone group: 1 discontinued, infection of scalp Notes: none
Interventions	Run‐in details: antihistamines and emollients stopped 2 days before the start of the trial Intervention: mometasone furoate 0.1% cream used twice daily for up to 6 weeks · Concurrent treatment: not reported · Other key information: none Comparator: hydrocortisone 1% cream used twice daily for up to 6 weeks · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: The amount of medication used each week was weighed and recorded. Instructions for application were given by an unblinded investigator. Bathing was not permitted for ≥ 8 hours after application, and occlusive dressings were not allowed. The participants' usual bathing routine and soaps were to be continued unchanged throughout the trial, and any food/environmental allergens that the participant had avoided prior to the trial were to be avoided.
Outcomes	· AEs · Morning plasma cortisol levels and other laboratory tests including complete blood cell count, blood electrolytes, glucose, liver enzymes · Global evaluations of improvement: 1 = cleared (100% clearance of signs and symptoms), 2 = marked improvement (≥ 75% clearance), 3 = moderate improvement (≥ 50% clearance), 4 = slight improvement · Per cent BSA involvement · Prespecified target lesion severity score: sum of 5 signs and symptoms: erythema, lichenification, skin surface disruption i.e. crusting and scaling, excoriation, and pruritus, each scored between 0 = none and 3 = severe · Parents' evaluation of efficacy of treatment
Notes	Funding source: Schering‐Plough Research, Kenilworth, N.J. 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.