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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of lesions that are completely clear or with minimum residual signs
Secondary outcome measures
Therapeutic procedure

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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,946 Previous Clinical Trials
13,204,498 Total Patients Enrolled
1 Trials studying Hemangioma
10,000 Patients Enrolled for Hemangioma
R. Rox Anderson, MDPrincipal InvestigatorMassachusetts General Hospital
4 Previous Clinical Trials
143 Total Patients Enrolled

Media Library

Observation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01873131 — N/A
Hemangioma Research Study Groups: Topical Timolol, Observation, Pulsed Dye Laser
Hemangioma Clinical Trial 2023: Observation Highlights & Side Effects. Trial Name: NCT01873131 — N/A
Observation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01873131 — N/A
~12 spots leftby Dec 2025
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