Skip to main content
. 2019 Apr 26;2019(4):CD004055. doi: 10.1002/14651858.CD004055.pub2

Bayerl 1999.

Methods Parallel‐group, randomised controlled trial
The study was conducted in the secondary setting at 2 different dermatology departments in Germany
Participants 48 participants with chronic hand eczema (21 irritant, 18 allergic, 9 atopic) > 3 months' duration, more than 30% of the hands involved. All had occupation‐related hand eczema: 41% were in a wet occupation
 Dropouts: 12
Inclusion criteria of the trial
  • Occupational chronic hand eczema of > 3 months' duration

  • > 30% involvement of hands


Exclusion criteria of the trial
  • Non‐compliance

  • Liver disease

  • Porphyria

  • Polymorphic light dermatitis

  • Use of light‐sensitive medication

  • Malignancies

  • Use of chemotherapies or immunosuppressives

  • History of skin malignancies

  • Specific topical or systemic therapy (including corticosteroids and coal tar)


Study population
  • Gender: not stated

  • Age: not stated

Interventions Intervention
• UV‐B phototherapy 5 days/week for 8 weeks in 19/24 participants
Control intervention
• No UVB for 8 weeks in 17/24 participants
Both groups were allowed to use non‐specific creams/emollients
Duration
8 weeks
Outcomes Primary outcomes of the trial
Not defined
Other outcomes
  • Observer‐rated extent of hand eczema, and scoring 1 to 4 (1 = absent, 2 = mild, 3 = moderate, 4 = severe) on erythema, oedema, maceration, excoriation, lichenification, fissuration, infection, scaling, itch

  • Participant‐rated VAS (0 to 10) on itching and restrictions in daily life

  • TEWL and Nitrazinyellow‐test

  • Adverse events

Notes Study authors rightly state that this is a pilot study. Only graphic presentation of a few components of some outcome parameters. Not clear, but assumed, that 24 participants were randomised to each group. The secondary outcome ‐ reduction in severity, investigator‐rated ‐ was included but did not provide reproducible data
Study authors were contacted on 7 March 2014 and responded 10 March 2014
Declarations of interest: not stated
Funding: not stated
Sample size rationale: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The article states only that the study is randomised, without details about the method of randomisation. Personal communication clarified that the same method was used as in Adams 2007: "cards with the characterisation "A" and "B" were enclosed in envelopes by a third person, mixed like a card play by a third person, then numbered consecutively by a third person and opened by the study doctor consecutively after informed consent to the study" This is an adequate method
Allocation concealment (selection bias) Low risk No details about whether the allocation was concealed from participants and investigators in the article, but personal communication clarified that this was done appropriately by a third person, and that the study doctor and participants opened the consecutively numbered envelopes after informed consent was retrieved
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and personnel were not blinded during the study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Observers were not blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk No intention‐to‐treat analysis but per protocol (36 of 48 = less than 80%)
Selective reporting (reporting bias) Low risk No trial registration found; however outcomes described in Materials and Methods are depicted in the Results section and are adequate
Other bias Unclear risk Baseline comparisons: no baseline comparisons regarding group differences (randomisation check)
Diagnostic certainty: yes
The study was completed