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

Baskan 2005.

Methods Within‐participant, placebo‐controlled, randomised controlled trial
The study was conducted in the secondary setting at a single centre in Turkey
Participants 25 participants with moderate to severe bilateral hand dermatitis with a minimal duration of 6 months
Dropouts: 1
Inclusion criteria of the trial
  • Bilateral hand dermatitis

  • Moderate to severe hand eczema with a minimal duration of 6 months

  • 18 years of age or older


Exclusion criteria of the trial
  • Pregnancy

  • Lactation

  • Use of systemic immunosuppressants

  • Other diagnosis such as urticaria, psoriasis, bacterial or fungal infection

  • Illness in the previous 4 weeks


Study population
  • Gender: 15 female, 9 male

  • Age: mean 35.8 years, range 18 to 63 years

Interventions Intervention
• Pimecrolimus 1% cream twice daily in 24/25 hands presumably for 8 weeks
Control intervention
• Placebo cream twice daily presumably for 8 weeks in 24/25 hands
• Participants were followed up for the same period
Duration
16 weeks (8 weeks active treatment, 8 weeks follow‐up)
Outcomes Primary outcomes of the trial
Not defined
Other outcomes
• Clinical response to therapy; erythema, desquamation, lichenification, oedema, vesiculation, and fissuring were scored between 0 and 4 and were controlled at 2nd, 4th, 6th, and 8th weeks of therapy
• Clinical response to therapy for pruritus
• At the end of therapy, participants were followed up for the same period to observe recurrences
• Adverse events
Notes Conference abstract from which only limited information can be extracted
Study authors were contacted for additional information, which led to review of an additional full‐text article in Turkish. The secondary outcome ‐ reduction in severity, investigator‐rated ‐ was included but did not provide reproducible data
Declarations of interest: not stated
Funding: not stated in the paper, but personal communication clarified that study authors did not receive any funding
Sample size rationale: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Study authors stated randomised but gave no clear description of how this was attained. Personal communication with study authors clarified that they used a card drawing system
Quote: "a simple randomisation method by card drawing was performed"
Allocation concealment (selection bias) Low risk No information on how allocation was concealed from participants and investigators is provided in the abstract Personal communication clarified that one investigator drew the cards after participants gave their consent. The topical drugs were packed in yellow and red boxes, and staff gave participants the corresponding boxes for treatment, without knowledge about the content of those boxes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Not clear from the abstract; however personal communication clarified that dispensation of study drug was done by a third person in boxes labelled for each hand. The vehicle and pimecrolimus were packed in similar boxes and were indistinguishable for participants
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not clear from the abstract; however personal communication clarified that observation was done by another physician who was not involved in randomisation or drug dispensation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Unclear whether an intention‐to‐treat analysis was conducted; however 24 of the 25 included participants completed the study, which is more than 80%
Selective reporting (reporting bias) Low risk No trial registration found. All relevant clinical signs were scored in the symptom score, and all described outcomes were depicted in the Results section
Other bias Low risk No baseline comparisons were conducted or reported, as within‐participant study was not applicable
Diagnostic certainty: yes
The study was completed