๐ฌIn plain words
What the trial is, and whether it could suit you
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 hemang
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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.
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What it tests
- topical timolol maleate
- Pulsed dye laser
Massachusetts General Hospital
Boston, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.