NCT01873131Recruiting
A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn
Preventing Growth of Hemangioma Tumors in Newborn: A Prospective Randomized Clinical Study
Source: ClinicalTrials.gov · Last updated 2 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 pulsed-dye laser or timolol maleate can prevent hemangioma from growing when used very early after birth.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 20 Aug 2012
- Start date
- Feb 2011
- Primary completion date
- Dec 2025
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT01873131
What you commit to
- Study type: Interventional
- Planned participants: 126
- From Feb 2011 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Infants already on other treatment prior to PDL or timolol treatments (including topical, systemic steroids or other agents)
- 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.
Other illness
- 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
- Scarring or infection of the area to be treated
Other
- Infants with hemangiomas that threaten vital functions (e.g. obstructing the airway or impairing hearing or vision)
- Subjects who are immunocompromised
- Subject whose parent/guardian is unable to comply with treatment, home care or follow-up visits
Who the study is looking for
- 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.
Age in the registry: - to 3 months · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.