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

Faghihi 2008.

Methods Within‐participant, randomised controlled trial
This study was conducted in a secondary setting at 2 different centres in Iran
Participants 47 participants with nearly symmetrical chronic hand eczema with a duration > 4 weeks
No dropouts
Inclusion criteria of the trial
  • Symmetrical chronic hand eczema with duration > 4 weeks

  • Older than 12 years of age


Exclusion criteria of the trial
  • Pregnancy

  • No topical treatment during the last 2 weeks nor systemic medication treatment in the last month

  • Systemic illness


Study population
  • Gender: 35 female, 12 male

  • Age: range 17 to 74 years

Interventions Intervention
• 0.05% clobetasol + 2.5% zinc sulphate cream on 1 hand in 47 participants for 2 weeks
• 0.05% clobetasol cream alone on the other hand in 47 participants for 2 weeks
Duration
2 weeks
Outcomes Primary outcomes of the trial
Not defined
Other outcomes
  • Assessment and scoring of different characteristics of hand eczema, namely, scaling, erythema, lichenification, and itch, on a 3‐point scale

  • Severity of itching evaluated by means of the visual analogue scale (VAS)

  • Adverse events

Notes Overall severity of hand eczema was not an outcome. Use of the Mann‐Whitney U‐test for statistical analysis appears incorrect, as the data were related (within‐subject design)
The secondary outcomes ‐ reduction in severity, participant‐rated, and time until relapse ‐ were included but did not provide reproducible data
Study authors were contacted by mail on 28 February 2014 but remained unresponsive
Declarations of interest: not stated
Funding: the study was funded and supported by Isfahan University of Medical Sciences
Sample size rationale: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "... right or left hand of them were randomised to be treated..."
Comment: no further details given
Allocation concealment (selection bias) Unclear risk No details about how allocation was concealed from participants and investigators
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "the patients and investigators were blinded to type of treatment"
Comment: the drugs were made in "similar shape" by a third party; this is considered an adequate way to blind participants
Quote: "drugs were made by the Isfahan Pharmacy School in the similar shape, and the patients and investigators were blinded to the type of treatment"
Comment: the code of drugs was revealed only at the end of the study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "drugs were made by the Isfahan Pharmacy School in the similar shape, and the patients and investigators were blinded to the type of treatment. The code of drugs was revealed only at the end of the study"
Comment: no details regarding blinding of outcome assessors, although study authors mention a double‐blind design; this is insufficient information to judge the risk of bias
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "overall, 47 patients (94 samples) were evaluated and all of them completed the study"
Comment: all participants completed the study and were included in the analyses
Selective reporting (reporting bias) Unclear risk No trial registration found. All outcomes described in Subjects and Methods are described in the Results section, although for itch, only the statistical significance level is stated, but the other outcomes are stated in tables with exact numbers
Other bias Low risk Baseline comparisons revealed no significant differences between groups in terms of erythema, scaling, lichenification, and pruritus; further within‐participant design
Diagnostic certainty: yes
The study was completed