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

NCT00810862.

Study characteristics
Methods Trial design: randomised, single‐blind, within‐participant study
Trial registration number: NCT00810862
Country: not reported
Outpatient or hospital: not reported
Date trial conducted: November 2006 to June 2008
Duration of trial participation: three weeks
Inclusion criteria:
· African‐American children aged 2 to 17 years
· Mild‐to‐moderate AD
Exclusion criteria:
· mEASI < 3
· Allergy to elidel or components
· Oral steroids, immunosuppressive agents, cytostatics or phototherapy within 4 weeks
· Continuous or noncontinuous use of pimecrolimus or tacrolimus for > 11 months within 2 weeks
· Active skin infections
· Immunocompromised
· History of skin cancer or lymphoma
· Hypopigmentation in study areas
· Pregnancy or breastfeeding
Additional design details: none
Participants Total number randomised: 36 sides treated (18 to apply the intervention and 18 to apply the comparator)
Age: 2 to 17 years
Sex: male or female
Ethnicity: African‐American
Duration of eczema: not reported
Severity of eczema: mild‐to‐moderate
Body site, number of withdrawals: not reported
Notes: none
Interventions Run‐in details: not reported
Intervention: pimecrolimus 1% cream twice daily for 21 days
Concurrent treatment: not reported
Other key information: none
Comparator: vehicle cream twice daily for 21 days
Concurrent treatment: not reported
Other key information: none
Concurrent treatments received alongside both intervention and comparator: not reported
Notes: none
Outcomes · mEASI
· Modified IGA
· Hypopigmentation
Notes Funding source: Children's Hospital of Michigan
Declarations of interest: not declared
Original language of publication: English
Other: early termination of study due to lack of enrolment