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Pulsed-dye Laser vs. Topical Timolol for Hemangioma

N/A

Recruiting

Led By R. Rox Anderson, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infant with one or more superficial hemangiomas in the preproliferative phase or very early proliferative growth phase

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test whether pulsed dye laser or timolol maleate is better at preventing hemangioma growth when given very early after birth.

Who is the study for?

This trial is for infants under 3 months old with a type of birthmark called hemangioma that appeared shortly after birth. The child must not have received any prior treatments, and the parents/guardians must agree to follow the study's treatment plan and care requirements.

What is being tested?

The study tests if pulsed dye laser or timolol maleate gel can prevent the growth of hemangiomas in newborns. It compares these treatments against no intervention to see which is more effective and safe for treating these birthmarks early on.

What are the potential side effects?

Potential side effects may include skin irritation, redness, or scarring from the laser treatment. Timolol could cause low heart rate, breathing difficulties, or other systemic effects since it's not yet FDA-approved for treating hemangiomas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My infant has a birthmark that is growing.

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My child's guardian agrees to only use medications for hemangioma provided by the study.

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I am under 3 months old.

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My parent/guardian agrees to let me receive an experimental treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant has a hemangioma that is affecting their breathing, hearing, or sight.

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The area to be treated has scarring or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of lesions that are completely clear or with minimum residual signs

Secondary study objectives

Therapeutic procedure

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Topical TimololExperimental Treatment1 Intervention

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.

Group II: Pulsed Dye LaserExperimental Treatment1 Intervention

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.

Group III: ObservationActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pulsed dye laser

2019

N/A

~270

0 / 6Eligibility criteria met