Roth 1978a.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, within‐participant study Trial registration number: not reported Country: USA Outpatient or hospita, date trial conducted: not reported Duration of trial participation: 4 weeks or until clearance Inclusion criteria: bilateral lesions of chronic AD, primarily on the limbs Exclusion criteria: pregnancy Additional design details: three eligible trials were reported in the same publication; described here as Roth 1978a; Roth 1978b; Roth 1978c. |
| Participants | Total number randomised: 58 sides treated (29 to apply the intervention and 29 to apply the comparator) Age, sex: not reported separately for each trial Ethnicity: not reported Duration of eczema: mean 12.1 years Severity of eczema: not reported Body site: to quote: "primarily on the limbs"; otherwise unspecified Number of withdrawals: not reported Notes: none |
| Interventions | Run‐in details: participants receiving systemic or topical steroids discontinued at least 2 weeks preceding the trial. Participants receiving anti‐metabolites were discontinued at least 3 months before. Intervention: hydrocortisone valerate 0.2% cream used three times daily for 4 weeks · Concurrent treatment: not reported · Other key information: brand: Westcort Comparator: hydrocortisone 1% cream used three times daily for 4 weeks · Concurrent treatment: not reported · Other key information: brand: Cortdome Concurrent treatments received alongside both intervention and comparator: some medications were permitted during the trial (e.g. antihistamines for allergic rhinitis, insulin for diabetes, antibiotics, tranquillisers), with the dosage kept at pre‐trial levels or changed only as therapeutically necessary. However, no anti‐metabolites, steroids (systemic or topical) were permitted. Notes: participants were asked to wash their hands between applications, and to apply the cream marked 'left' with the right hand, and the cream marked 'right' with the left hand. Plastic gloves were provided for the participants to wear on the hand applying the medication if there were lesions on the hands being treated. |
| Outcomes | · Assessment of signs/symptoms: pruritus, erythema, scaling, excoriation, and lichenification evaluated on a 10‐point scale, with cleared = 0 for all symptoms · Participant reports of AE · Participant judgement of which side had responded better · Overall judgement of which side had responded better · Overall judgement defined as cleared, excellent, good, no effect or worse |
| Notes | Funding source: not reported Declarations of interest: not declared; however, one of the authors stated Westwood Pharmaceuticals Inc, Buffalo, New York as their affiliation. Original language of publication: English Other: this study has previously been extracted by this group; some content is reproduced from Lax 2022. |