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

Uggeldahl 1986.

Methods Within‐participant, randomised controlled trial
This study was conducted in a secondary care setting, probably at 2 centres in Finland
Participants 50 (46) participants (1.5 to 70 years) with bilateral moderate hand/wrist/lower arm eczema, with left‐right comparable severity, were included; 4 were excluded because of asymmetrical hand eczema
 Dropouts: 2
Inclusion criteria of the trial
  • Bilateral and symmetrical moderate eczema of the hand, wrist, and lower arm


Exclusion criteria of the trial
  • Not stated


Study population
  • Gender: not stated

  • Age: mean 27 years, range 1.5 to 70 years

Interventions Intervention
• Desonide cream 0.1% twice daily for 2 weeks in 44/46 hands
• Desonide cream 0.05% twice daily in 44/46 contralateral hands for 2 weeks
Duration
2 weeks
Outcomes Primary outcomes of the trial
Not defined
Other outcomes
  • Observer‐rated score 0 to 4 (0 = absent and 4 = maximum severity) for inflammation, infiltration, desquamation, lichenification, itching, tenderness, and chapping, after 4 to 7 days and after 11 to 14 days

  • Participant‐rated therapeutic effect: both hands equal or one hand better than the other at days 11 to 14

  • Adverse events

Notes In fact, 50 participants were randomised, but 4 participants were excluded at the start. Not clear whether inclusion criteria of the trial (hand/wrist/lower arm) stipulated that the hands had to be involved in all participants. The youngest participant was 1.5 years old
Aim was to study equivalency, but this was not reflected in the analysis
The secondary outcomes ‐ reduction in severity, investigator‐rated and participant‐rated ‐ were included but did not provide reproducible data
Declarations of interest: 2 study authors were employees of the research department at Apothekernes Laboratorium A.S., Oslo, Norway, the manufacturer of the study drugs
Funding: see above item
Sample size rationale: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "the study consisted of a double‐blind, randomized, left‐right comparative study..."
Comment: stated only that this was a randomised study. No further details provided
Allocation concealment (selection bias) Low risk Quote: "each patient was given 2 tubes identical in appearance...."
Quote: "according to the double‐blind nature of the study, the creams were randomly allocated to the left and right side..."
Comment: no details about how allocation was concealed from participants and clinicians. The identical tubes were randomly allocated to left and right sides
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "each patient was given 2 tubes identical in appearance...."
Comment: the only difference between the 2 tubes was the concentration, wherefore this is considered as low risk
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "...double‐blind nature..."
Comment: unclear whether observers were aware of the treatment modalities, although study authors claim double‐blind design
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No intention‐to‐treat analysis but per protocol (44 or 46 of 50 = more than 80%)
Selective reporting (reporting bias) Low risk No trial registration found. No major discrepancies between Methods and Results sections
Other bias Low risk Baseline comparisons: within‐participant study not applicable
Diagnostic certainty: yes
The study was completed