Pulsed-Dye Laser or Timolol for Newborn Hemangiomas

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

Recruiting N/A Interventional Study
Hemangioma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
Up to 3 Months
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
126 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for

This trial is looking for infants under 3 months old with a specific type of birthmark called hemangioma. Participating involves receiving either a laser treatment or a gel and following care instructions from the study team.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am an infant under 3 months old.
  • I have one or more superficial hemangiomas.
  • I noticed a change in my hemangioma within the first month after birth.
  • My parent or guardian agrees to participate in this study.
  • My parent or guardian has signed a consent form.
  • My parent or guardian is willing to follow the treatment schedule.

You may not be able to join if

  • I have received any treatment for my hemangioma before this study.
  • I have a serious medical problem that makes it hard to participate.
  • My hemangiomas threaten my airway or impair my hearing or vision.
  • I have scarring or infection in the treatment area.
  • I am immunocompromised.
  • My parent or guardian cannot follow the treatment or care requirements.
  • I have asthma or a history of asthma.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
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 sp…
Trial Locations
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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…
Contacts

Thanh Nga T Tran, MD PhD

617 724-4937

ttran2@partners.org

CONTACT

Yakir Levin, MD

617 724-4937

YLEVIN2@PARTNERS.ORG

CONTACT