Randomised controlled trial: Can topical timolol maleate prevent complications and reduce the need for further treatment for small superficial infantile haemangiomata in high risk areas?

The study was the first Chinese study to define the role of topical timolol maleate (TTM) in the treatment of infantile haemangiomata (IH). Our team included all <1-year-old infants within a 13-month period presenting with small (<2cm) superficial IH located at high risk areas (i.e. tip of ears, tip of nose, eyelids, acral areas, facial areas, scalp, neck, buttocks, perineum and axilla). Patients either received 12 months of 0.5% timolol maleate solution (study group) or watchful waiting (control group). Both groups were monitored and treated similarly. The primary outcome was IH with development of complications that required additional interventions. The secondary outcomes included side effects of TTM and change in IH size. 42 children were eligible to the study. Patients who received TTM were noted to have significantly fewer complications than the control group (4.2% vs 29%). Mean IH volume percentage reduction was significantly more for the TTM group and no-TTM group at 3 months, 6 months and 12 months after study uptake. We concluded that TTM is an effective and safe treatment option to reduce complications, IH volume and the need for further intervention for infants with small superficial infantile haemangioma located at high risk areas.