Fadrhoncova 1982.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, single‐centre, within‐participant study Trial registration number: not reported Country: Czech Republic, assumed from the affiliation of the author Outpatient or hospital: hospitalised patients at a dermatology clinic in Prague, assumed from the affiliation of the author Date trial conducted: not reported Duration of trial participation: 4 weeks Inclusion criteria: patients with bilateral and symmetrical eczema on the limbs and torso (not face) Exclusion criteria: · Signs of impetiginisation · Pregnancy · Malignant disease Additional design details: none |
| Participants | Total number randomised: 52 sides treated (26 to apply the intervention and 26 to apply the comparator) Age: range 2 to 66 years Sex: males n = 10: females n = 16 Ethnicity: not reported Duration of eczema: not reported Severity of eczema: the paper gives mean scores on various clinical parameters at baseline, but it is very difficult to interpret Body site: limbs and torso (not face) Number of withdrawals: 2 participants did not tolerate the treatment and were excluded after week 1. The final column of table 2 (n) suggests that there were no further withdrawals Notes: none |
| Interventions | Run‐in details: not reported Intervention: hydrocortisone butyrate 0.1% cream used twice daily for 4 weeks · Concurrent treatment: not reported · Other key information: none Comparator: hydrocortisone 1% cream used twice daily for 4 weeks. · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: no occlusion. Both participants and nurses were instructed to wash their hands between left and right side applications to prevent contamination Notes: none |
| Outcomes | · Investigator assessment of 10 clinical signs and symptoms (pruritus, lichenification, infiltration, erythema, exudation, amount of crusts, amount of vesicles, amount of papules, amounts of pustules, and exfoliation), scored from 0 = absent to 4 = very severe, reported separately as group means (SD) and as a combined score. Combined score assumed to be the mean value of each sign/symptom multiplied by the number of participants reporting that sign, summed for all signs/symptoms · Participant and physician preference for each treatment over the other · AE |
| Notes | Funding source: not reported Declarations of interest: not declared Original language of publication: Czech; translated for Lax 2022 by Simona Slezáková Other: this study has previously been extracted by this group; some content is reproduced from Lax 2022 |