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. 2024 Aug 6;2024(8):CD015064. doi: 10.1002/14651858.CD015064.pub2

Kuokkanen 1987.

Study characteristics
Methods Trial design: randomised, double‐blind, within‐participant study
Trial registration number: not reported
Country: Finland (assumed from author affiliations)
Outpatient or hospital, date trial conducted: not reported
Duration of trial participation: 3 weeks
Inclusion criteria:
· White children aged 2 to 10 years
· Diagnosed with eczema (bilateral, symmetrical) and otherwise in general good health
· To quote: "the severity of erythema, induration, and pruritus at test sites was rated on a 4‐point scale ranging from 0 (absent) to 3 (severe). To be included in the trial, a child had to have (a) each sign or symptom, (b) the rating of the severity of each had to be equal at paired test sites, (c) the ratings at each test site had to total at least 6, and (d) the condition had to be stable or slowly worsening for more than one week."
Exclusion criteria:
· Evidence of skin atrophy
· Hypersensitivity to any component of either trial medication
· Use of topical or systemic steroids within the 2 weeks of the trial
· Requirement for > 45 gm of medication weekly per test site
· Use of any treatment known to affect eczema within a month of the trial
· Requirement for medication (topical or systemic) that might affect the course of eczema
Additional design details: none
Participants Total number randomised: 37 sides treated (16 applied to the right side (intervention) and 18 applied to the right side (comparator))
Age: randomised to right‐side intervention, mean 6.8 years, range 2.0 to 10.0; randomised to right‐side comparator, mean 7.6 years, range 3.0 to 10.0
Sex: randomised to right‐side intervention, male n = 10, female = 6; randomised to right‐side comparator, male n = 9, female n = 9
Ethnicity: all were white.
Duration of eczema: right‐side intervention, mean 4.5 years, range 0.3 to 8; right‐side comparator, mean 6.2 years, range 1 to 10
Severity of eczema: right‐side intervention group: stable n = 5, slowly worsening n = 10, rapidly worsening n = 1; right‐side comparator group, stable n = 6, slowly worsening n = 10, rapidly worsening n = 2
Body site: to quote: "lesions on the arms, legs, or torso were selected as paired test sites in each participant".
Number of withdrawals: 3 did not return after the initial visit and were not included. Two received antibiotics during the trial and were evaluated for safety but not comparative efficacy. Eight did not return for follow‐up visits "at the weekly interval" but were still included in efficacy evaluations.
Notes: 6 per group, had been treated with treatments previously; 11 had received hydrocortisone lotions or liniments, 3 with emollient creams or ointments. 1 participant also received antihistamine for urticaria for 4 days in the 1st week of treatment.
Interventions Run‐in details: not reported
Intervention: alclometasone dipropionate 0.05% ointment used twice daily for 3 weeks
· Concurrent treatment: not reported
· Other key information: none
Comparator: hydrocortisone 1% ointment used twice daily for 3 weeks
· Concurrent treatment: not reported
· Other key information: none
Concurrent treatments received alongside both intervention and comparator: participants were to apply enough to cover the test site and to gently massage in the medications. They were also instructed to wash their hands carefully between applications. Nothing other than trial treatments could be applied to the test sites.
Notes: to quote: "When lesions cleared in less than three weeks, application of the trial medication was to continue but in an area of only 3 cm2 within each test site."
Outcomes · Sum of erythema, induration, and pruritus at paired test sites (0 = absent to 3 = severe)
· AE assessed by careful examination and questioning of caregivers at each visit
· Visual assessment of test site for signs of cutaneous atrophy; skin thinning, shininess, striae, bruising, telangiectasia, loss of hair, elasticity and normal skin markings and wasting of muscle and subcutaneous fat. Skin thinning, shininess, and striae were graded on a 4‐point scale from 0 = absent to 3 = severe. Telangiectasia was evaluated at a 3 cm2 area by counting visible blood vessels within each test site using a 2 x magnifying lens.
· Comparative efficacy (equivalent, alclometasone results better or hydrocortisone results better)
· IGA: cleared (100% clearance of monitored signs and symptoms except for residual discolouration); markedly improved (75% to < 100% clearance of monitored signs and symptoms); moderately improved (5 0% to < 75% clearance of monitored signs and symptoms); slightly improved (< 50% clearance of monitored signs and symptoms); unchanged; or exacerbated
Notes Funding source: not reported
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.