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. |