Timolol maleate 0.5% or 0.1% gel-forming solution for infantile hemangiomas: a retrospective, multicenter, cohort study

Pediatr Dermatol. Jan-Feb 2012;29(1):28-31. doi: 10.1111/j.1525-1470.2011.01664.x. Epub 2011 Dec 9.


Therapeutic options for superficial infantile hemangiomas (IH) are limited. Recently, timolol maleate gel, a topical nonselective beta-blocker, has been reported as a potentially effective treatment for superficial IH. This study is an extension of a previously published pilot study designed to further investigate the efficacy and safety and to identify predictors of good response of topical 0.5% or 0.1% timolol maleate gel-forming solution. This was a retrospective cohort study including patients enrolled from five centers. Patients were included if they were treated with timolol maleate 0.1% or 0.5% gel-forming solution and had photographic documentation of the IH and at least one follow-up visit. Patients with concomitant active treatment using other IH treatments were excluded. The primary endpoint was change in the appearance of IH as evaluated using a visual analog scale (VAS). Data from 73 subjects were available for final analysis. Timolol maleate gel-forming solution 0.5% was used in 85% (62/73) of patients, the remainder being treated with 0.1%. The median age at treatment initiation was 4.27 months (interquartile range [IQR] 2.63-7.21 mos), and patients were treated for a mean of 3.4 ± 2.7 months. All patients except one improved, with a mean improvement of 45 ± 29.5%. Predictors of better response were superficial type of hemangioma (p = 0.01), 0.5% timolol concentration (p = 0.01), and duration of use longer than 3 months (p = 0.04). Sleeping disturbance was noted in one patient. This study further demonstrates the efficacy and tolerability of topical timolol maleate and gradual improvement with longer treatment in patients with superficial IH.

Publication types

  • Multicenter Study

MeSH terms

  • Administration, Topical
  • Adrenergic beta-Antagonists / administration & dosage
  • Cohort Studies
  • Female
  • Gels
  • Hemangioma / drug therapy*
  • Humans
  • Infant
  • Male
  • Retrospective Studies
  • Skin Neoplasms / drug therapy*
  • Solutions / administration & dosage
  • Timolol / administration & dosage*
  • Treatment Outcome


  • Adrenergic beta-Antagonists
  • Gels
  • Solutions
  • Timolol