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 |