Whalley 2002.

Methods	Parallel group, double blind, placebo control, multi‐centre, randomised controlled trial
Participants	Inclusion criteria: children (N = 241), mild to moderate eczema (diagnosis criteria: Williams et al.), IGA score 2 or 3, TBSA > 5%, age 2 to 17 years, total 430 patients, only patients over than 8 years were included, QoL score available for 241 of 278 participants. Exclusion criteria: not stated. Wash out period: not stated.
Interventions	pimecrolimus 1.0% BID (n=158) vs. vehicle BID (n=83) for six weeks
Outcomes	1. Efficacy: mean PIQoL‐AD score 2. Safety and tolerability: total WDs
Notes	We did not include data for the six‐month, open‐label trial period. This study assessed parents of those aged two to eight years to obtain the QoL data.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

AD: atopic dermatitis; IGA: investigators' global assessment; PGA: participants' global assessment; WDs: withdrawals; BID: twice daily; QID: four times daily; QD: once a day; EASI: eczema area and severity index. Eczema Area and Severity Index (EASI) scores is a method to characterize the extent of eczema. It is generally an indicator for the severity of eczema, such as IGA score, and may also be used to follow up the treatment effect. An EASI score of 15 to 20 indicates approximately a 10% to 15% body involvement of eczema (atopic dermatitis). Mild AD is defined by areas of scaling, papulation, erythema, and lichenification of 5 to 10 cm involving less than 15% total body surface area. Typical areas of involvement would include the wrists, antecubital fossa, knees, popliteal fossa, and ankles.; TS: topical corticosteroids; TBSA: total body surface area; ADSI: Atopic Dermatitis Severity Index, uses a 4‐point (0‐3) scale for erythema, pruritus, exudation, excoriation, and lichenification, and calculates the sum of these 5 ratings (range, 0 to 15); RCT: randomised controlled trial; ADEs: adverse drug events; flare‐free days: the numbers of days on study without topical corticosteroid use; achieving clear or almost clear AD: IGA score 0‐1; 95% CI: 95% confidence interval; DLQI: Dermatology Life Quality Index; QoLI‐AD: Quality of Life Index‐ Atopic Dermatitis; CDLQI: Children's Dermatology Life Quality Index; PIQoL‐AD: Parent's Index of Quality of Life‐ Atopic Dermatitis; PQoL‐AD: Parents' Quality of Life Index‐ Atopic Dermatitis