Hebert 2008b.
| Study characteristics | |
| Methods | Trial design: randomised, mulitcentre study Trial registration number: not reported Country: USA Outpatient or hospital: multicentre Date trial conducted: July 2004 to July 2005 (patients enroled) Duration of trial participation: four weeks Inclusion criteria: · Age 3 months to 17 years · AD according to Hanifin and Rajka criteria · ISGA score of 2 or 3 out of 5 (mild‐to‐moderate severity) · Sum of scores for erythema, induration/population, and oozing/crusting (each 0‐4) of more than or equal to 4 · ≥ 25% BSA · Normal cosyntropin stimulation test (serum cortisol > 18.0 g/dL) Exclusion criteria: · Any disease of the HPA axis (e.g. Addison’s disease, Cushing’s syndrome, pituitary tumour) · Known hypersensitivity to any component of study medication, cosyntropin, or natural adrenocorticotropic hormone · Use of any investigational therapy 4 weeks before the study · Systemic therapy or phototherapy for AD within 4 weeks of the study · Topical therapies for AD within 1 week of the study · Use of oestrogens, spironolactone or systemic retinoids within 8 weeks of, and during, the trial · Pregnancy or unwilling to use reliable contraception during the study Additional design details: none |
| Participants | Total number randomised: 81 participants Age: mean 6.7 years (SD 5.1) Sex: females n = 51, males n = 30 Ethnicity: Asian n = 5, African‐American n = 29, white n = 35, Hispanic n = 10, other n = 2 Duration of eczema: not reported Severity of eczema: 74% had moderate disease at baseline Body site: not reported Number of withdrawals: 5 participants did not complete the treatment period, due to lost to follow‐up n = 3, AE n = 1, and disease progression n = 1 Notes: none |
| Interventions | Run‐in details: not reported Intervention: desonide 0.05% foam used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle foam used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · HPA axis suppression · Local AE |
| Notes | Funding source: Stiefel Laboratories Inc. Declarations of interest: to quote: "Disclosure: The principal authors have served as clinical investigators on other studies sponsored by Stiefel Laboratories Inc." Original language of publication: English Other: local safety data is presented only in a pooled analysis with Hebert 2008a and Hebert 2008c, extracted once under Hebert 2008a |