The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5% doses.
Primary: Describe the efficacy of 0.25% and 0.5% topical timolol maleate Gel-forming solution (GFS) as assessed through Infantile Hemangioma (IH) changes in volume. Secondary: Describe the safety of topical timolol maleate GFS for treatment of IH.
Documented informed consent from legal guardian
0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort.
Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following):
Superficial lesion in the dermis
Thin <2 mm in thickness
Small >=5 cm at its longest dimension and <=10cm2
Involves skin or keratinized mucosa
History of previous treatment with any pharmacologic or laser therapy for IH
Ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot (TOF), hypertension, reactive airways disease)
IH that requires systemic therapy (defined by dynamic complication scale >3)
IH of the non-keratinized mucosa
Infants with more than one hemangioma that requires therapy
Hemodynamically significant cardiovascular disease, as determined by the investigator
Known allergy to beta blockers or vehicle
Heart rate <100 beats per minute at screening visit
Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block
History of Reactive Airways Disease (RAD)
Any condition which would make the participant, in the opinion of the investigator unsuitable for the study.
0.25% Timolol Maleate Gel Forming Solution
0.5% Timolol Maleate Gel Forming Solution
January 24, 2022
Kanecia Zimmerman, MD MPH
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
For more information and to contact the study team: