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. 2019 Apr 26;2019(4):CD004055. doi: 10.1002/14651858.CD004055.pub2

Veien 1999.

Methods Parallel‐group (3 groups), randomised controlled trial
This study was conducted in a secondary care setting at 3 centres in Denmark (study was carried out at a university department as well as at 2 private dermatology clinics)
Participants 106 participants were randomised (all patch tested) with hand eczema > 6 months that had cleared upon daily treatment for a maximum of 9 weeks with mometasone furoate cream
120 participants were recruited, and 14 dropped out during the initial phase
 No dropouts after randomisation (see notes)
Inclusion criteria of the trial
  • Eczematous hand dermatitis for longer than 6 months with a minimum score of 6 according to the adopted scoring system


Exclusion criteria of the trial
  • Infection to the hands

  • Hyperkeratotic hand eczema

  • Other hand dermatoses

  • Contact allergy to the topical remedies used in the study

  • Fungal infection of hands/feet

  • Pregnant and lactating women

  • Use of systemic immunosuppressants


Study population
  • Gender: 100 female, 20 male in the recruited group

  • Age: median 31 years, range 17 to 70 years, in the recruited group

Interventions Intervention
• Mometasone furoate cream thrice weekly (Sunday/Tuesday/Thursday) for up to 36 weeks or 30 (?) in 35/35 participants
• Mometasone cream twice weekly (Saturday/Sunday) for up to 36 weeks in 37/37 participants
Control intervention
• No corticosteroids in 34/34 participants
Emollients (Essex cream and ointment) used in all groups
In case of recurrence, all groups were permitted to use mometasone daily for a maximum of 3 weeks at separate period
Additional treatment was permitted in all groups in case of a bacterial infection
Duration
Up to 36 weeks
Outcomes Primary outcome of the trial
  • Number of recurrences of hand eczema and times at which recurrence occurred (recurrence defined as eczema score equal to or higher than initial score)


Other outcomes
  • Length of time it took to control the dermatitis during the initial treatment period

  • Numbers and times of recurrence in subgroups. Data analysis by survival analysis

  • Adverse events

Notes All randomised participants were supposed to be free of eczema due to preceding treatment (induction of remission) with mometasone, yet recurrence was defined as a score equal to or higher than before this remission induction phase. In each group, a few participants received additional treatment. Dropout was defined as participant who had more than 2 recurrences
The secondary outcome ‐ time until relapse ‐ was included in the study, but data were not reproducible
Study authors were contacted on 7 March 2014 but responded on 13 March 2014 that they were unable to provide additional information
Declarations of interest: not stated
Funding: Schering‐Plough A/S Farum, Denmark, supplied the study drugs and covered the expenses of processing the data
Sample size rationale: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients.... were randomised into 1 of 3 groups"
Comment: no further details in the article. Personal contact with the study author clarified that the randomisation table was computer generated with blocks of 5, and this was carried out by Schering‐Plough A/S, Farum, Denmark
Allocation concealment (selection bias) Low risk No details in the article about how allocation was concealed from participants and clinicians; however personal contact with study authors clarified that randomisation was created by a third party. The investigators received sealed and numbered envelopes for allocation to a treatment arm
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "ideally, the maintenance phase should have been double‐blind. This would, however, have required a very complicated distribution of the medicaments, with many different tubes for various days of the week. We felt the risks of mistakes by the patients and of poor compliance to be too great"
Comment: no blinding; blinding was difficult because participants had to follow different treatment schedules
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "the investigation was carried out as an open, prospective, randomized trial"
Comment: no blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "the intention‐to‐treat principle was used to calculate the effect of the treatments"
Comment: intention‐to‐treat analysis
Selective reporting (reporting bias) Low risk No trial registration found. Severity of pruritus, erythema and vesicles, scaling, and fissures is described in the Materials and Methods section, but separate results for these are not given in the Results section; however, because these are not listed as outcome, we judged this as low risk. All (clearly described) outcomes listed in the Materials and Methods section are included in the Results section
Other bias Low risk Baseline comparisons: "there were no statistically significant differences in the demographic features represented in the 3 centres or in the 3 randomisation groups"
Diagnostic certainty: yes
The study was completed