A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn
Hemangioma
About this trial
This is an interventional prevention trial for Hemangioma focused on measuring hemangioma, infantile hemangioma, pulsed dye laser, PDL, topical beta blocker, timolol maleate, timolol
Eligibility Criteria
Inclusion Criteria:
- Subjects aged less than 3 months, male or female.
- Infant with one or more superficial hemangiomas in the preproliferative phase or very early proliferative growth phase.
- Absence or minimal appearance of the lesion at birth
- More pronounced appearance within 1 month of birth.
- Willingness of parent/guardian to participate in the study
- Willingness of parent/guardian to receive EXPERIMENTAL treatment
- Informed consent agreement signed by the parent/guardian
- Willingness of parent/guardian to follow the treatment schedule and post treatment care requirements
- Willingness of parent/guardian to not use topical or systemic (oral) TREATMENT medications of the hemangioma other than those prescribed by the investigators during the study period.
Exclusion Criteria:
- Infants already on other treatment prior to PDL or timolol treatments (including topical, systemic steroids or other agents)
- Any infant who, in the opinion of his or her pediatrician or the investigators, has a major medical problem (such as cardiac pathology or airway obstruction) that makes participation in the study difficult
- Infants with hemangiomas that threaten vital functions (e.g. obstructing the airway or impairing hearing or vision)
- Scarring or infection of the area to be treated
- Subjects who are immunocompromised
- Subject whose parent/guardian is unable to comply with treatment, home care or follow-up visits
- Patients with asthma or a history of asthma, chronic obstructive pulmonary disease or cardiovascular disease, including sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock; hypersensitivity to any component of timolol; and in those patients receiving systemic administration of beta-blockers or ace inhibitors.
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
Experimental
Topical Timolol
Observation
Pulsed Dye Laser
After verification of eligibility criteria and obtaining informed consent of parent/guardian, infants randomized to the timolol arm will receive twice daily topical application of a physician-specified amount of timolol maleate 0.5% ophthalmic solution (hereby referred to as topical timolol) for up to six months.
After verification of eligibility criteria and obtaining informed consent of parent/guardian, infants randomized to the observation arm will be followed at study visits according to protocol.
After verification of eligibility criteria and obtaining informed consent of parent/guardian, infants randomized to the pulsed dye laser arm will receive a series of six weekly to semi-weekly laser treatments treatments for up to 6 treatments with potential for reduced number of treatments if the hemangioma completely resolves. A 595-nm pulsed-dye laser (PDL, V-beam Perfecta, Candela Corp, Wayland, MA) with a dynamic cooling device (DCD) will be utilized for all treatments. This device is cleared by the FDA for clinical treatment of vascular lesions.