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?

Objective: To define the role of topical timolol maleate (TTM) in the treatment of infantile haemangiomata (IH). We hypothesised that TTM is superior to watchful waiting for treatment of IH. Study design: In this single-centre randomised controlled trial, we 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.