Lodén 2012a.

Methods	Parallel‐group, randomised controlled trial This study was carried out in a secondary setting at 4 outpatient clinics in Norway This study consists of 2 parts (Lodén 2010); only the second part is included in this review
Participants	44 participants with a clinically proven history of hand eczema and a recent relapse participated in part 1 of this trial No dropouts Inclusion criteria of the trial Clinically proven history of hand eczema with a recent relapse Daily use of moisturising treatment Either gender Age 18 or older Written informed consent Exclusion criteria of the trial Possible allergy to ingredients in the study medications At study start, active psoriatic lesions or active atopic eczema lesions on the hands Active bacterial, fungal, or viral infection of the hands Participants who are pregnant or breastfeeding, or who plan to become pregnant during the course of the study Use of any concomitant medication that may interfere with study‐related activities or assessment of efficacy Any participant‐related factor suggesting potentially poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse) Any serious medical condition that, in the opinion of the investigator, may interfere with evaluation of results Inclusion in a study of an investigational drug within 60 days before the start of treatment Study population Gender: 27 female, 17 male Age: mean 46 years, range 22 to 76 years
Interventions	Intervention • Betamethasone 0.1% cream twice daily in 22 participants during 2 weeks • Betamethasone 0.1% cream once daily + urea 5% cream once daily in 22 participants during 2 weeks Duration 2 weeks
Outcomes	Primary outcomes of the trial Not defined Other outcomes Participant‐rated severity on a 100‐mm visual analogue scale (VAS), where 0 was no eczema and 100 extreme severe eczema. This was done daily Investigator‐rated severity of Hand Eczema Extent score (HEES); clearance was defined as a score ≤ 3 Participant‐rated quality of life using the validated Dermatology Life Quality Index (DLQI) at baseline and after 2 weeks
Notes	Short duration of 2 weeks Declarations of interest: study authors were paid consultants or employees of ACO Hud Nordic AB Funding: the study was funded by ACO Hud Nordic AB (manufacturer of the study drug) and by Knowledge Foundation, Stockholm, Sweden Sample size rationale: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "the coded tubes were sequentially numbered according to a randomization list which was prepared and retained by the contract research organization" Comment: reference to a prepared randomisation list
Allocation concealment (selection bias)	Low risk	Quote: "the coded tubes were sequentially numbered according to a randomization list which was prepared and retained by the contract research organization" Comment: the randomisation list was prepared and retained by the contract research organisation. The tubes were coded and sequentially numbered, and the clinicians who dispensed the tubes to participants were blinded. This is considered as low risk of selection bias because randomisation was done at a remote site
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "the patients, the clinicians, those assessing the outcomes and those making the data analyses were blinded" Quote: "the treatment was double‐blinded and combined with a moisturizer cream (M) (5% urea, Canoderm, ACO Hud AB, Sweden). All patients received two coded tubes; one for evening applications, labelled ‘evening’ and containing BV and one for morning applications, labelled ‘morning’ and containing either BV or M. The creams had a similar texture, were white and did not contain perfume" Comment: double‐blind design. The different creams were identical in appearance and were labelled by a contract research organisation
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "the patients, the clinicians, those assessing the outcomes and those making the data analyses were blinded" Comment: the observations and the data analysis were conducted by blinded assessors
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "all included participants received treatment and were analysed" Comment: no dropouts
Selective reporting (reporting bias)	Unclear risk	The trial was registered on clinicaltrials.gov (NCT00576550) as part 2. The primary outcomes registered in the trial register are for part 1 of the study (Lodén 2010), not for part 2. Therefore it is difficult to judge the risk of reporting bias In the article, there are no major discrepancies between the Methods and Results sections
Other bias	Unclear risk	Baseline comparisons: no baseline comparisons regarding group differences (randomisation check) Diagnostic certainty: yes The study was completed