NCT02913612.

Trial name or title	Efficacy, safety and pharmacokinetics of topical timolol in infants with infantile hemangioma (IH) (TIM01)
Methods	Multicentre, double‐masked randomised, efficacy, safety, and pharmacokinetic study
Participants	110 children up to 60 days
Interventions	Drug: 0.25% timolol maleate gel forming solution Drug: 0.5% timolol maleate gel forming solution Wait‐and‐see
Outcomes	Primary outcomes: Comparison of partial response of haemangioma colour within the treatment arm compared to the untreated controls Partial response of haemangioma colour from baseline to 180 days within each treatment arm and compared with untreated controls
Starting date	12 August 2016
Contact information	Chiara Melloni, Principal Investigator, Duke University Medical Center
Notes	This study is not yet open for participant recruitment.

PHACE syndrome: posterior fossa malformations–haemangiomas–arterial anomalies–cardiac defects–eye abnormalities syndrome.