Actively Recruiting
Preventing Growth of Hemangioma Tumors in Newborns: A Randomized Study Comparing Pulsed Dye Laser, Timolol Gel, and Observation
Led by Massachusetts General Hospital · Updated on 2023-11-02
126
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether pulsed dye laser treatment or timolol maleate 0.5% gel can help infants with hemangiomas, which are common birthmarks caused by clusters of blood vessels. The study also examines the safety of these treatments to ensure they do not cause too many side effects. Hemangiomas typically appear soon after birth and often disappear on their own, but some require treatment due to potential health risks or disfigurement. Infants will be randomly assigned to one of three groups: one receiving a series of up to six weekly or semi-weekly pulsed dye laser treatments using an FDA-cleared 595-nm laser device; another receiving twice daily topical applications of timolol maleate 0.5% ophthalmic gel for up to six months; or an observation group receiving no treatment. The laser treatments involve protective eyewear and carefully controlled laser energy, while the timolol dose is adjusted to cover the hemangioma area without excess medication. Participants will be monitored regularly with clinical assessments and digital photographs to measure hemangioma size and response over two years. Researchers will record treatment outcomes, side effects, parents' cosmetic satisfaction, functional improvements, and any additional treatments needed. This follow-up period aims to determine how early treatment with laser or timolol affects hemangioma growth and complications compared to no treatment.
CONDITIONS
Brief Title
A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged less than 3 months, male or female
- Infant with one or more superficial hemangiomas in the preproliferative or early proliferative phase
- Lesion absent or minimally visible at birth
- More noticeable appearance within 1 month of birth
- Parent/guardian willing to participate and provide informed consent
- Parent/guardian willing to follow treatment schedule and post-treatment care
- Parent/guardian agrees not to use other hemangioma treatments during the study except those prescribed by investigators
You will not qualify if you...
- Infants already treated with other therapies before laser or timolol
- Major medical problems that make study participation difficult
- Hemangiomas threatening vital functions like airway, hearing, or vision
- Scarring or infection at treatment site
- Immunocompromised subjects
- Parent/guardian unable to comply with treatment, home care, or follow-up
- History of asthma, chronic lung disease, heart conditions, or hypersensitivity to timolol components
- Use of systemic beta-blockers or ACE inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive one of the following interventions: a series of weekly to semi-weekly pulsed dye laser treatments for up to 6 sessions; or twice daily topical application of timolol maleate ophthalmic gel for up to six months; or no treatment with observation only.
Weekly to semi-weekly visits for up to 6 laser treatments or regular visits during timolol application period
Duration - Up to 2 years
Participants are assessed for hemangioma clearance, cosmetic outcome, functional improvement, need for additional treatment, and adverse reactions for up to 2 years after treatment ends.
Periodic visits over 2 years for assessment
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
T
Thanh Nga T Tran, MD PhD
Y
Yakir Levin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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