Recruiting

Pulsed-Dye Laser vs. Timolol

Sponsor:

Massachusetts General Hospital

Code:

NCT01873131

Conditions

Hemangioma

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

topical timolol maleate

Pulsed dye laser

Study Details

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 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.

Conditions

Hemangioma

Study ID

NCT01873131

Start date

Feb, 2011

Status verified date

Nov, 2023

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Topical Timolol

After verification of eligibility criteria and obtaining informed consent of parent/guardian, infants randomized to the timolol arm will receive twice daily topical application of a physician-specified amount of timolol maleate 0.5% ophthalmic solution (hereby referred to as topical timolol) for up to six months.

no intervention: Observation

After verification of eligibility criteria and obtaining informed consent of parent/guardian, infants randomized to the observation arm will be followed at study visits according to protocol.

experimental: Pulsed Dye Laser

After verification of eligibility criteria and obtaining informed consent of parent/guardian, infants randomized to the pulsed dye laser arm will receive a series of six weekly to semi-weekly laser treatments treatments for up to 6 treatments with potential for reduced number of treatments if the hemangioma completely resolves. A 595-nm pulsed-dye laser (PDL, V-beam Perfecta, Candela Corp, Wayland, MA) with a dynamic cooling device (DCD) will be utilized for all treatments. This device is cleared by the FDA for clinical treatment of vascular lesions.

Interventions

topical timolol maleate

Timolol maleate 0.5% ophthalmic solution will be used. The dose will be 1 drop per square centimeter of hemangioma, rubbed into the area by the parent/guardian twice daily. The intent is to cover the entire lesion without excess of medication. Therefore, the dose can be lowered from 1 drop/cm2 at the discretion of the investigators, but not increased. This dose should not have significant systemic side effects given that the normal systemic intravenous dose for propanolol is 2mg/kg/day and there would be much less systemic absorption if the solution is applied topically. It is well established that the stratum corneum greatly slows the transport of timolol.

Pulsed dye laser

A 595-nm PDL (V-beam Perfecta, Candela Corp, Wayland, MA, USA) with a dynamic cooling device (DCD) will be utilized for all treatments. This device is cleared by the FDA for clinical treatment of vascular lesions. Protective eyewear for patient and all participants in the treatment room will be provided. A spot size of 7 or 10 mm will be used with an average fluence (energy delivered per unit area, in J/cm2) of 9 J/cm2 (range 8-10.0 J/cm2). Fluence will vary according to patient and hemangioma characteristics, including age, skin type, location, lesion thickness and response to treatment. A 30-50 ms cryogen spray cooling (CSC) duration will precede the laser pulse duration of 0.4 ms.

Primary outcome measure

  • Proportion of lesions that are completely clear or with minimum residual signs [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Thanh Nga T Tran, MD PhD

617 724-4937ttran2@partners.org

Yakir Levin, MD

617 724-4937YLEVIN2@PARTNERS.ORG

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Thanh Nga T Tran, MD PhD

617-724-4937ttran2@partners.org

Ray H Jalian, MD

617 724-4937hjalian@partners.org

Principal Investigator:

R. Rox Anderson, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 2, 2023

Last verified

Nov, 2023

Keywords

  • hemangioma
  • infantile hemangioma
  • pulsed dye laser
  • PDL
  • topical beta blocker
  • timolol maleate
  • timolol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2023-11-02.