Trial NCT01873131
A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn
- Phase
- Not given
- Sponsor
- Massachusetts General Hospital
- Conditions
- Hemangioma
- Ages
- 0–0.25 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 shockCardiac; hypersensitivity to any component of timolol; and in those patients receiving systemic administration of beta-blockers or ace inhibitors.
Restrictions found (1)
- CardiacConditionalexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County