Skip to main content
. 2024 Aug 6;2024(8):CD015064. doi: 10.1002/14651858.CD015064.pub2

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.