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

Schnopp 2002.

Methods Within‐participant, randomised controlled study
This study was carried out in a secondary care setting at a single dermatology department in Germany
Participants 16 participants with moderate to severe chronic relapsing dyshidrotic eczema on hands
No dropouts
Inclusion criteria of the trial
  • Moderate to severe chronic relapsing dyshidrotic hand eczema


Exclusion criteria of the trial
  • Use of topical glucocorticoids or any systemic treatment with possible influence on the course of hand eczema


Study population
  • Gender: 15 female, 1 male

  • Age: mean 43 years, range 23 to 54 years

Interventions Intervention
• Tacrolimus 0.1% ointment twice daily on 12/12 hands for 4 weeks
• Mometasone furoate 0.1% ointment twice daily on 12/12 contralateral hands for 4 weeks
Follow‐up period was up to 8 weeks after the end of treatment
Duration
12 weeks (4 weeks of active treatment, up to 8 weeks of follow‐up)
Outcomes Primary outcome of the trial
  • Observer‐rated dyshidrotic eczema area and severity index (DASI) at baseline, week 2, and week 4 (based on sum‐score for severity 1 = mild, 2 = moderate, 3 = severe for, respectively, vesicles, erythema, desquamation, and itch multiplied by score for affected area)


Other outcomes
  • Adverse events

Notes Originally, 20 participants with hand and/or foot involvement, 4 of whom were excluded due to poor disease control during the trial‐preceding washout phase. Study in 16 participants, of whom 12 had their hands involved. The limited data on the 4‐week post‐treatment follow‐up period are difficult to interpret. Outcome scores at week 4 presented graphically, without exact numbers Scoring of outcome (DASI) same as the study by Odia
The secondary outcomes ‐ reduction in severity, participant‐rated, and time until relapse ‐ were included but did not provide reproducible data
Study authors were contacted 3 March 2014 and replied 4 March 2014
Declarations of interest: none declared
Funding: no funding
Sample size rationale: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomly assigned....."
Comment: no further details were given in the article; however personal communication with study authors clarified that they threw dice to create a randomisation list
Allocation concealment (selection bias) Low risk No details in the article about how allocation was concealed from participants and clinicians. Contact with study authors clarified that the randomisation list was composed by a third person. This person was involved in the distribution of study drugs, but not in the recruiting. The third person held office in a different building of the hospital that was not accessible for physicians
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "this study was a randomized, observer‐blinded, intraindividual comparison study..."
Comment: participants were not blinded during the study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "all assessments were performed by an independent observer on separate sheets on different premises. Patients were instructed not to talk about treatment modalities"
Comment: study authors clearly described how they tried to prevent detection bias. Observers were blinded adequately
Incomplete outcome data (attrition bias) 
 All outcomes Low risk None of the participants dropped out during the study; all participants were included in the analyses (16 of 16 = 100%)
Selective reporting (reporting bias) Low risk No trial registration found; however the DASI is a valid score for hand eczema and was described in the Methods and Results sections without major discrepancies
Other bias Low risk Baseline comparisons: within‐participant study not applicable
Diagnostic certainty: yes
The study was completed