Aschoff 2009.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, single‐centre, within‐participant study Trial registration number: NCT00180141 Country: Germany Outpatient or hospital: one health centre in Germany, assume outpatient Date trial conducted: April 2005 to June 2007 Duration of trial participation: 3 weeks Inclusion criteria: · ≥ 18 years of age · AD according to the Hanifin and Rajka's criteria, on at least 1% of skin surface area on both forearms · Atopic Dermatitis Severity Index (ADSI) score of at least 6 (range 0 to 15, with higher score for more severe symptoms) (difference between right and left arm ≤ 1) · IGA of 2 or 3 on both forearms Exclusion criteria: · Participation in a clinical study within the last 4 weeks · Systemic therapy with cytostatics or immunosuppressants within the last 24 weeks · Antibiotic or topical therapy to treat AD in the last 2 weeks · Known allergy to components of pimecrolimus cream 1% · Genetic defects of the epidermal barrier (e.g. Netherton syndrome) · Acute viral infection (e.g. herpes simplex) in the target area · Severe AD (IGA ≥ 4) · Immune incompetence · Skin malignancies · Drug or alcohol abuse · Pregnancy and breastfeeding · Women of childbearing age without reliable contraception Additional design details: none |
| Participants | Total number randomised: 40 sides treated (20 to apply intervention and 20 to apply vehicle) Age: mean 25.7 years (range: 18 to 58) Sex: female n = 11, male n = 9 Ethnicity: not reported Duration of eczema: mean 16.89 years (range: 0.36 to 45.78) Severity of eczema: IGA score 7 mild, 13 moderate Body site: forearm Number of withdrawals: 0 Notes: none |
| Interventions | Run‐in details: none Intervention: pimecrolimus 1% cream used twice daily for 3 weeks Concurrent treatment: not reported Other key information: none Comparator: vehicle cream used twice daily for 3 weeks Concurrent treatment: not reported Other key information: none Concurrent treatments received alongside both intervention and comparator: hydrocortisone‐acetate 1% (once daily) or emollients on all body surface areas but excluding the forearms Notes: none |
| Outcomes | · ADSI at 21 days · Investigator's Global Assessment (IGA) at 21 days · Pruritis using visual analogue scale (VAS) 0 to 10 at 21 days · Microcirculation, skin hydration, transepidermal water loss (TEWL) to 21 days |
| Notes | Funding source: Technische Universität Dresden Declarations of interest: not declared Original language of publication: English Other: none |