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. 2018 Apr 18;2018(4):CD006545. doi: 10.1002/14651858.CD006545.pub3

Asilian 2015.

Methods
  • Design: parallel ‐ 2 arms

  • Country: Iran

  • Method of randomisation: children were divided into 2 groups in double‐blind manner. Each group had 16 haemangiomas. Group A was treated with 585 PDL and timolol maleate and Group B with 585 PDL plus lubricant gel as a placebo.

  • Blinding: double‐blind

  • Location: Alzahra hospital (Referral Center for Treatment of Skin Diseases)

  • Length of follow‐up: 6 months

Participants
  • Diagnosis: cutaneous haemangioma causing complications such as deformity, ulceration, bleeding, infection, or damage of orifices

  • Sex: 24 female, 8 male

  • Age: between 1 and 12 months

  • Inclusion criteria: healthy infants between 1 month and 12 months old with superficial haemangioma ≤ 3 cm and with a history of sensitivity to beta blockers or asthma, renal disease, heart disease, hypoglycaemia, use of drugs that interact with beta blockers

  • Exclusion criteria: haemangiomas > 3 cm, infants older than 1 year, no sensitivity to beta blockers

  • Number of randomised children: 30 (2 children with 2 haemangiomas)

Interventions
  • Intervention A (Number of children: 15): children were treated with 4 sessions of PDL and timolol maleate gel 0.05%.

  • Intervention B (Number of children: 15): PDL plus lubricant gel as placebo

Outcomes
  • Primary: improvement in appearance, colour, and size. 2 forms of assessment were used: (1) clinical score for the overall change and (2) visual analogue scale similar to that employed in other objective studies.

  • Secondary: not stated

Notes
  • Trial registration: not stated

  • Funder: not stated

  • Role of funder: not stated

  • A priori sample size estimation: not stated

  • Conducted: January 2011 to January 2012

  • Declared conflicts of interest: not declared

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Then, patients were divided into two groups in [a] double blind manner."
Comment: There was insufficient information to rate this item as low or high risk of bias.
Allocation concealment (selection bias) Unclear risk There was insufficient information to rate this item as low or high risk of bias.
Blinding of participants (Performance bias) Low risk Quote: " (...) Group B with 585 PDL plus lubricant gel as placebo." Page 2
Comment: Placebo intervention was used.
Blinding of personnel (performance bias) Unclear risk There was insufficient information to rate this item as low or high risk of bias.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk There was insufficient information to rate this item as low or high risk of bias.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No children were lost at follow‐up.
Selective reporting (reporting bias) Low risk Selective reporting of information was not detected.
Other bias Low risk No other biases were detected.