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. 2024 Aug 6;2024(8):CD015064. doi: 10.1002/14651858.CD015064.pub2

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