Traulsen 1997b.
Study characteristics | |
Methods | Trial design: randomised, double‐blind study Trial registration number: not reported Country: Denmark Outpatient or hospital: 3 Nordic centres Date trial conducted: not reported Duration of trial participation: 14 days Inclusion criteria: · At least 12 years of age · Suffering from AD with two affected symmetrical skin areas with comparable activity Exclusion criteria: · Pregnant or nursing women, patients · Clinical signs of infection of the selected skin areas · Treated with systemic corticosteroid within 1 month, with topical steroids within 1 week before the baseline assessment or with another treatment which might have affected the clinical status of the eczema Additional design details: paper presented two studies, one on cream (Traulsen 1997a) and one on ointment (Traulsen 1997b). |
Participants | Total number randomised: 164 sides treated (82 to apply the intervention and 82 to apply the comparator) Age: mean 23.3 years, range from 14 to 40 years Sex: male n = 31, female n = 49 Ethnicity, duration of eczema: not reported Severity of eczema: to quote: "The overall severity of atopic dermatitis was found to be moderate in 43 patients, severe in 23 patients and very severe in 11 patients. The disease at entry was ‘improving’ in 1, ’stable’ in 36 and ’worsening’ in 43 patients". Body site: not reported Number of withdrawals: 2; did not fit inclusion criteria n = 1, lost to follow‐up n = 1 Notes: none |
Interventions | Run‐in details: not reported Intervention: hydrocortisone propionate 0.1% ointment used once daily for 14 days · Concurrent treatment: not reported · Other key information: none Comparator: betamethasone valerate 0.1% ointment used once daily for 14 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: locobase cream was used as the inactive preparation for non‐affected skin areas and for morning application to affected areas not selected for evaluation. Notes: none |
Outcomes | · Sum scores for the five symptoms: erythema, scaling, vesiculation, papules and pruritus · Investigator overall evaluation of the clinical effects · Patient preference regarding efficacy and cosmetic properties |
Notes | Funding source: Nycomed Pharma (Basoderm a/s) and Taisho Inc. Declarations of interest: not reported Original language of publication: English Other: none |