title: RCT of timolol maleate gel for superficial infantile hemangiomas in 5- to 24-week-olds.
abstract: OBJECTIVE
  Timolol maleate 0.5% gel is a safe and effective medication for treating superficial infantile hemangiomas (IHs) in infants with a median age of 9 weeks.
  
  
  METHODS
  Forty-one infants who had superficial IHs without ulceration and not near mucosal surfaces were recruited and randomly assigned to placebo and treatment (timolol maleate 0.5% gel) groups. Efficacy was assessed by performing blinded volume measurements at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, and 24 and blinded investigator photograph scoring at weeks 0, 12, and 24. Safety was assessed by measuring heart rate and systolic and diastolic blood pressure at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, and 24.
  
  
  RESULTS
  Fifteen of the 19 infants receiving treatment and 17 of the 22 infants receiving placebo completed the study. Significant color change on the blinded photographic scores was noted at week 24 of the study (P = .003). There was a significantly higher proportion of treated IHs that reduced in size by >5% at weeks 20 and 24 (P < .02). The predicted proportion of IH volume change was also significantly less for treated IHs from week 16 onward when compared with placebo (P < .05). There was no significant variation in blood pressure and heart rate between the groups.
  
  
  CONCLUSIONS
  Topical timolol maleate 0.5% gel with a maximum dose of 0.5 mg per day is a safe and effective option for small superficial IHs that have not ulcerated and are not on mucosal surfaces.
authors: Sydney Children's Hospital, New South Wales, Australia. hsien.chan@gmail.com
authors: Hsien
authors: H
authors: Chan
authors: Catherine
authors: C
authors: McKay
authors: Susan
authors: S
authors: Adams
authors: Orli
authors: O
authors: Wargon
mesh_terms: D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006391:Hemangioma / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008297:Male; D012878:Skin Neoplasms / Q000188:drug therapy*; D013999:Timolol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005782:Gels; D013999:Timolol
keywords: infantile hemangioma; randomized controlled trial; timolol/adverse effects