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. 2019 Jan 22;2019(1):CD012167. doi: 10.1002/14651858.CD012167.pub2

Kircik 2013.

Methods Study design: randomised controlled trial
Study grouping: parallel group
Participants Baseline characteristics
Overall
  • Number of participants randomised: 40

  • Losses to follow‐up: 7

  • Age: M = 41.1 (19.5 to 68.1)

  • Duration of condition: not reported

  • Severity of condition: not reported ("subjects with uncomplicated atopic dermatitis")

  • Male/Female: 13/26 (1 missing value for gender)


Inclusion criteria: (1) diagnostic: no information given on how atopic dermatitis was defined; (2) severity of condition: "subjects with uncomplicated atopic dermatitis"; (3) duration of condition: no information given; (4) site evaluated (e.g. face/back); no information given
Exclusion criteria: not reported
Group differences: information from interim report: "the treatment groups were balanced with respect to all demographic and baseline characteristics"
Interventions Intervention characteristics
Levocetirizine
  • Presentation: tablets

  • Dose and frequency: 5 mg 1×/d

  • Total dose: 5 mg/d

  • Duration given for: 4 weeks

  • Supplier and trade name if relevant: Xyzal


Placebo
  • Presentation: tablets

  • Dose and frequency: 1×/d

  • Total dose: n/a

  • Duration given for: 4 weeks

  • Supplier and trade name if relevant: not reported

Outcomes Primary outcome 1: mean change in patient‐assessed symptoms: pruritus
  • Outcome type: continuous outcome

  • Direction: lower is better


Primary outcome 2: adverse events
  • Outcome type: adverse event

  • Notes: "no treatment related AEs were noted in either group"


Secondary outcome 2: mean change in quality of life, as measured by a standardised or validated quality of life measure (e.g. Dermatology Life Quality Index ‐ DLQI (Finlay 1994))
  • Outcome type: continuous outcome

  • Direction: lower is better

Identification Sponsorship source: UCB Pharmaceuticals
Country: USA
Setting: secondary
Comments: single‐centre
Author's name: Leon Kircik
Institution: Mount Sinai Health System
Address: 1169 Eastern Pkwy # 2310, Louisville, KY 40217, United States
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Information about the sequence generation process insufficient to permit judgement of low risk or high risk
Allocation concealment (selection bias) Unclear risk Information insufficient to permit judgement of low risk or high risk
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Information insufficient to permit judgement of low risk or high risk
Comment: it is not clear whether medication was identical in appearance to placebo
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information given as to how assessor was blinded (i.e. information insufficient to permit judgement of low risk or high risk)
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient reporting of attrition/exclusions to permit judgement of low risk or high risk. No information given about attrition given. Although study authors report no missing outcome data, whether all randomised participants contributed to data collection remains unclear
Selective reporting (reporting bias) High risk Comment: reporting of data was rudimentary in the report and did not allow us to run necessary analyses. Contacting the study author failed as the study author did not respond
Other bias Unclear risk Further risk of bias is possible, but information is insufficient to judge whether additional bias exists (e.g. no conflict of interest statement provided, but study was funded by UCB Pharmaceuticals)