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

Veien 1984.

Study characteristics
Methods Trial design: randomised, double‐blind, multicentre, within‐participant study
Trial registration number: not reported
Country: Denmark (assumed from the authors affiliations)
Outpatient or hospital: outpatients from dermatology clinics (assumed from the authors affiliations)
Date trial conducted: not reported
Duration of trial participation: 4 weeks
Inclusion criteria:
· Chronic, symmetrical and bilateral AD
· Aged < 10 years
· Either sex
Exclusion criteria: not reported
Additional design details: none
Participants Total number randomised: 80 sides treated (40 to apply the intervention and 40 to apply the comparator)
Age: mean 4.1 years (SD 2.9), range from 10 months to 10 years
Sex: male n = 23, female n = 17
Ethnicity: not reported
Duration of eczema: not reported (other than "chronic")
Severity of eczema: moderate n = 18 participants, severe n = 21, very severe n = 1. Mean score 2.6 (SD 0.6) based on a 5‐point scale from 0 = none to 4 = very severe
Body site: not reported
Number of withdrawals: one participant missed the 2‐week assessment, otherwise no dropouts reported
Notes: none
Interventions Run‐in details: not reported
Intervention: hydrocortisone butyrate 0.1% cream used twice daily for 28 days or until clearance
· Concurrent treatment: not reported
· Other key information: brand: Locoid
Comparator: hydrocortisone 1% cream used twice daily for 28 days or until clearance.
· Concurrent treatment: not reported
· Other key information: brand: Uniderm; considered to be an "advanced base formulation"
Concurrent treatments received alongside both intervention and comparator: to prevent contamination, all participants' parents/carers were told to wash their hands before applying each treatment. Treatments were applied without occlusion.
Notes: none
Outcomes · AE (spontaneously reported)
· Number completely healed (with no relapse)
· Participant/parent preferences rated as −2 = very much worse, −1 = worse, 0 = the same, 1 = better, 2 = very much better
· IGA using a 5‐point scale (0 = none, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe); therapeutic results rated as moderate for a 1‐point improvement, good for a 2‐point improvement and excellent for a 3‐point improvement
Notes Funding source: none stated; however, one author is affiliated to Gist‐brocades, The Netherlands.
Declarations of interest: not declared; however, one author is affiliated to Gist‐brocades, The Netherlands.
Original language of publication: English
Other: study has previously been extracted by this group; some content is reproduced from Lax 2022.