Meurer 2002.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, multicentre, parallel study Trial registration number: not reported Country: Germany Outpatient or hospital: dermatological university hospitals n = 12, dermatological clinic n = 1, dermatology practices n = 3 Date trial conducted: September 1999 to June 2000 Duration of trial participation: 24 weeks Inclusion criteria: · AD affecting at least 5 % of total BSA · IGA score 3 or 4 Exclusion criteria: · PUVA, high dose UVA, systemic therapy with corticosteroids, immunosuppressants or cytostatics in previous 3 months · Topical therapies for AD in previous 2 weeks · Systemic antibiotics in previous 2 weeks · Systemic steroids for indications other than AD in previous month · Pregnancy, lactation, women of childbearing age not using reliable contraception · Need for treatment with potent topical steroids · Severe concurrent allergic diseases · Diseases associated with immunosuppression or malignancy · Presence of skin conditions that could affect evaluation of study treatment · Active skin infections requiring treatment with a prohibited medication or active herpes simplex infections Additional design details: none |
| Participants | Total number randomised: 192 participants (96 to apply the intervention and 96 to apply the comparator) Age: 18 to 69 years Sex: intervention group, male n = 36, female n = 60; comparator group, male n = 41, female n = 55 Ethnicity, duration of eczema: not reported Severity of eczema: moderate‐to‐severe Body site: not reported Number of withdrawals: comparator group 37.5%; intervention group 22.9%. Withdrawals due to unsatisfactory therapeutic effect: comparator group 27.1%; intervention group 15.6% Notes: none |
| Interventions | Run‐in details: not reported Intervention: pimecrolimus 1 % cream twice daily for 24 weeks · Concurrent treatment: not reported · Other key information: none Comparator: vehicle twice daily for 24 weeks · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: prednicarbate 0.25 % cream was permitted as a rescue therapy for a maximum of 7 days twice daily, followed by a further 7 days once daily. Cetirizine was also permitted (no details). Notes: none |
| Outcomes | · IGA · EASI · Pruritis severity · Patient self‐assessment · Quality of life DLQI · Quality of life QoLIAD · AE |
| Notes | Funding source: Novartis Pharma Declarations of interest: three authors were employees of Novartis Pharma. Original language of publication: English Other: none |