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

Barba 2003.

Study characteristics
Methods Trial design: randomised double‐blind, multicentre, parallel study
Trial registration number: not reported
Country: Mexico
Outpatient or hospital, date trial conducted: not reported
Duration of trial participation: 3 weeks
Inclusion criteria:
· Paediatric patients (aged 3 months to 18 years) with mild‐to‐moderate AD of the face
Exclusion criteria: not reported
Additional design details: none
Participants Total number randomised: 114 participants (76 to apply the intervention and 38 to apply the vehicle cream)
Age: 3 months to 18 years
Sex, ethnicity, duration of eczema: not reported
Severity of eczema: mild‐to‐moderate
Body site: face
Number of withdrawals: 5/76 in the pimecrolimus group and 3/38 in the vehicle group did not complete. No reasons provided
Notes: none
Interventions Run‐in details: not reported
Intervention: pimecrolimus 1% cream used not specified for 21 days
Concurrent treatment: not reported
Other key information: none
Comparator: vehicle cream used not specified for 21 days
Concurrent treatment: not reported
Other key information: none
Concurrent treatments received alongside both intervention and comparator: none
Notes: none
Outcomes · Facial IGA at three weeks
· EASI at three weeks
· Pruritis at three weeks
· Patient assessment of good or complete control at three weeks
· AE at three weeks
Notes Funding source: not reported
Declarations of interest: not declared
Original language of publication: English
Other: one