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
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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)
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Interventions |
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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
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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
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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. |