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Study identifier: NCT01873131 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Hemangioma  ·  Sponsor: Massachusetts General Hospital

PhaseNA
Planned participants126
Who can joinAll sexes, N/A to 3 Months
Healthy volunteersYes

About this study

The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate 0.5% gel can help infants who have a hemangioma. The investigators also want to find out if pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too many side effects. Hemangioma is a common type of birthmark. These birthmarks happen when many new blood vessels grow in a specific area on the skin. Blood vessels are tiny tubes that carry blood through the body. No one knows what causes blood vessels to group together. Most birthmarks don't hurt at all and they usually aren't a sign of any kind of illness. Lots of newborns have these birthmarks on their bodies, like between the eyebrows. These birthmarks usually disappear within the first few months to years of life. These birthmarks tend to disappear spontaneously. Most hemangiomas are not treated unless the hemangioma threatens the child's health, which occurs in about 1 in 3 children with hemagiomas. Pulsed dye laser is widely used in children, and is approved by the U.S. Food and Drug Administration (FDA) for treating hemangioma. The FDA has approved timolol maleate to treat glaucoma in adults, but the FDA has not approved timolol maleate to treat hemangiomas in children. About 7 infants with hemangiomas have received timolol maleate. The results so far show that timolol maleate may be helpful and safe in treating hemangiomas in infants. An important question being tested in this study is whether …

This description comes directly from the study's public registry record.

Talk to the study team

Thanh Nga T Tran, MD PhD  ·  617 724-4937  ·  ttran2@partners.org

Yakir Levin, MD  ·  617 724-4937  ·  YLEVIN2@PARTNERS.ORG

Always discuss trial participation with your own doctor first.

Locations (1)

Massachusetts General HospitalBoston, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT01873131