Status:
RECRUITING
A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Hemangioma
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Hemangiomas affect 5-10% of all children born in the United States and up to 20% of premature infants, with a higher incidence in girls. Most infantile hemangiomas (IHs) appear within a few weeks of b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Infants already on other treatment prior to PDL or timolol treatments (including topical, systemic steroids or other agents)
- 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
- Infants with hemangiomas that threaten vital functions (e.g. obstructing the airway or impairing hearing or vision)
- Scarring or infection of the area to be treated
- Subjects who are immunocompromised
- Subject whose parent/guardian is unable to comply with treatment, home care or follow-up visits
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01873131
Start Date
February 1 2011
End Date
December 1 2028
Last Update
November 2 2023
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114