Comparing pulsed dye laser and timolol for treating hemangiomas in newborns
Preventing Growth of Hemangioma Tumors in Newborn: A Prospective Randomized Clinical Study
This study is testing whether a special laser or a cream can help treat hemangiomas in newborns better than just watching them grow.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | N/A to 3 Months |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT01873131 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of pulsed dye laser treatment and topical timolol maleate in infants with hemangiomas. It focuses on infants under three months old who are in the early stages of hemangioma growth. The study will compare these interventions against observation to determine their impact on hemangioma growth and potential side effects. The goal is to find a non-invasive treatment option that can prevent complications associated with hemangiomas.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under three months old with superficial hemangiomas in the early proliferative phase.
Not a fit: Patients with hemangiomas that are already being treated with other medications or those with significant complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective treatment option for infants with hemangiomas, reducing the need for more invasive interventions.
How similar studies have performed: Previous studies have shown promising results with pulsed dye laser and beta-blocker treatments for hemangiomas, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: R. Rox Anderson, MD — Massachusetts General Hospital
- Study coordinator: Thanh Nga T Tran, MD PhD
- Email: ttran2@partners.org
- Phone: 617 724-4937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.