A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jun 6, 2013

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for hemangiomas, which are common birthmarks in newborns caused by a cluster of blood vessels. The trial is comparing the use of a pulsed dye laser, which is a light therapy approved by the FDA for treating hemangiomas, to a topical solution called timolol maleate, which is approved for treating glaucoma in adults but is being tested for hemangiomas in infants. The goal is to see if either treatment can help prevent these birthmarks from growing when given early in life and to ensure that they are safe for infants.

To participate in the study, infants must be under 3 months old and have one or more hemangiomas that are just starting to grow. Parents or guardians need to be willing to engage in the study and follow the treatment plan. Throughout the trial, participants will receive either the laser treatment or the timolol solution, while also being monitored for any side effects. This research is important because, while most hemangiomas go away on their own, some can cause health issues, and this trial aims to find out the best way to manage them early on.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects aged less than 3 months, male or female.
• • 2. Infant with one or more superficial hemangiomas in the preproliferative phase or very early proliferative growth phase.
• • 3. Absence or minimal appearance of the lesion at birth
• • 4. More pronounced appearance within 1 month of birth.
• • 5. Willingness of parent/guardian to participate in the study
• • 6. Willingness of parent/guardian to receive EXPERIMENTAL treatment
• • 7. Informed consent agreement signed by the parent/guardian
• • 8. Willingness of parent/guardian to follow the treatment schedule and post treatment care requirements
• • 9. 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:
• • 1. Infants already on other treatment prior to PDL or timolol treatments (including topical, systemic steroids or other agents)
• • 2. 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
• • 3. Infants with hemangiomas that threaten vital functions (e.g. obstructing the airway or impairing hearing or vision)
• • 4. Scarring or infection of the area to be treated
• • 5. Subjects who are immunocompromised
• • 6. Subject whose parent/guardian is unable to comply with treatment, home care or follow-up visits
• • 7. 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.