A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Gr… (NCT01873131) | Clinical Trial Compass
RecruitingNot Applicable
A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn
United States126 participantsStarted 2011-02
Plain-language 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 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.
Who can participate
Age range3 Months
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Infants already on other treatment prior to PDL or timolol treatments (including topical, systemic steroids or other agents)
✕
What they're measuring
1
Proportion of lesions that are completely clear or with minimum residual signs
. 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.