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

Lauriola 2011.

Methods Parallel‐group, randomised controlled trial
This study was carried out in a secondary care setting at a single centre in Italy
Participants 40 participants with mild to moderate atopic dermatitis of hands
No dropouts
Inclusion criteria of the trial
  • Participants aged 18 years or older

  • Mild to moderate atopic dermatitis of hands, grading 3.0 to 5.0


Exclusion criteria of the trial
  • Topical treatment in the last 10 days

  • Systemic treatment in the last 2 weeks


Study population
  • Gender: not stated

  • Age: not stated

Interventions Intervention
• Furpalmate‐containing creams (0.3%) twice a day for 14 days in 20 participants
• Corticosteroid (hydrocortisone acetate 0.5%) twice a day for 14 days in 20 participants
Duration
2 weeks
Outcomes Primary outcomes of the trial
Not defined
Other outcomes
  • Observer‐rated: physician's global evaluation of clinical response and of individual signs (erythema, xerosis)

  • Participant‐rated assessment of itch (VAS)

  • Global response (unclear whether observer or participant rated)

  • Tolerability (adverse events)

  • Cosmetic compliance (unclear whether observer or participant rated)

Notes Conference abstract, from which only limited information can be extracted
The secondary outcomes ‐ reduction in severity, participant‐ and investigator‐rated ‐ were included but did not provide reproducible data
Study authors were contacted on 28 February 2014 but were not responsive
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) Unclear risk Quote: "a single‐center, randomized, prospective, investigator blinded, controlled trial..."
Quote: "...patients were randomly allocated..."
Comment: study authors stated randomised but gave no clear description of how this was attained
Allocation concealment (selection bias) Unclear risk No details of how allocation was concealed from participants and investigators
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "a single‐center, randomized, perspective, investigator blinded, controlled trial..."
Comment: study authors stated investigator‐blinded; participants were not blinded (open‐label?), although this is not clear
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "a single‐center, randomized, prospective, investigator blinded, controlled trial..."
Comment: the article states only that the study was done in an investigator‐blinded way. We considered this as insufficient information to judge this risk of bias
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "all patients completed the study period"
Comment: all participants completed the study
Selective reporting (reporting bias) High risk No trial registration found. The abstract is very concise, and not all outcomes listed in the Methods section are described in the Results section, for example, cosmetic aspects or adverse events
Other bias Unclear risk Baseline comparisons: no baseline comparisons regarding group differences (randomisation check)
Diagnostic certainty: yes
The study was completed