Sanabria‐Silva 1991.
Study characteristics | |
Methods | Trial design: randomised, parallel study Trial registration number: not reported Country: Mexico Outpatient or hospital: outpatients; National Institute of Paediatrics Date trial conducted: May to December 1985 Duration of trial participation: 4 weeks of treatment followed by 10 days of post‐treatment follow‐up Inclusion criteria: · Age 3 to 12 years · AD diagnosed by a doctor from the Dermatology Department · Lesions on > 30% of the body surface · The percentage affected was calculated based on the rule of 9s. Exclusion criteria: · Under 3 years old (due to absorption being greater in this age group) · Over 12 years old (due to AD being less common in adolescence) · Secondary infection · Hypersensitivity to corticosteroids · Concurrent systemic illness · Treated with topical or systemic steroids 4 weeks before the trial Additional design details: none |
Participants | Total number randomised: 45 participants (15 to apply intervention one, 15 intervention two and 15 to apply the comparator) Age: 28 pre‐school children: 17 school children Sex: females n = 14, males n = 31 Ethnicity: not reported Duration of eczema: not reported Severity of eczema: potent TCS group (15): 8 participants with 30 to 50% BSA affected, 6 with 51 to 70%, and 1 with > 70%; placebo group (15): 9 participants with 30 to 50% BSA affected, 6 with 51 to 70%; mild TCS group: not reported Body site, number of withdrawals: not reported Notes: none |
Interventions | Run‐in details: not reported Intervention: betamethasone dipropionate 0.0 5% cream used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Intervention: hydrocortisone 1% cream used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: placebo 0% cream used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: parents/carers were instructed at baseline on how to apply the medications. Rules of care were also recommended; these included: use of emollients when the skin appears dry; other medication was prohibited; bathing daily if possible; use of cotton underwear Notes: none |
Outcomes | · to quote: "Extensiveness of lesions" (noting percentage of skin affected, presence or absence of erythema, lichenification and scabs); and photographs · Number of participants relapsing · Number of participants experiencing rebound · AE |
Notes | Funding source: not reported Declarations of interest: not declared Original language of publication: Spanish Other: this study has previously been extracted by this group; some content is reproduced from Lax 2022. |