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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 belowSelect...
My infant has a birthmark that is growing.
Select...
My child's guardian agrees to only use medications for hemangioma provided by the study.
Select...
I am under 3 months old.
Select...
My parent/guardian agrees to let me receive an experimental treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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
2,929 Previous Clinical Trials
13,198,179 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a weakened immune system.The birthmark is very small or not visible.The area to be treated has scarring or infection.My condition became noticeable within a month after birth.My child's guardian agrees to only use medications for hemangioma provided by the study.I am under 3 months old.My parent/guardian agrees to let me receive an experimental treatment.I have asthma, COPD, heart issues, or am allergic to timolol. I also take beta-blockers or ACE inhibitors.My infant has a birthmark that is growing.My infant has a hemangioma that is affecting their breathing, hearing, or sight.My infant has been on treatments other than PDL or timolol.The baby has a significant health issue that might make it hard for them to take part in the study, according to their doctor or the researchers.
Research Study Groups:
This trial has the following groups:- Group 1: Topical Timolol
- Group 2: Observation
- Group 3: Pulsed Dye Laser
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Pulsed dye laser been employed in any other experiments of a similar nature?
"Currently, 8 clinical trials are underway that investigate the use of Pulsed dye laser. Of those studies, 4 have progressed to Phase 3 and 14 different medical centres around Campinas in São Paulo are taking part in their investigation."
Answered by AI
Is there an open enrollment period for this research endeavor?
"Clinicaltrials.gov's information confirms that this clinical trial, which was first posted on February 1st 2011, is still actively recruiting patients. This data was last updated as recently as August 10th 2022."
Answered by AI
What is the upper limit of participants in this experimental study?
"Affirmative. Per the information available on clinicaltrials.gov, this medical study is currently recruiting participants; it was initially posted February 1st 2011 and recently revised August 10th 2022. 126 individuals need to be enrolled from one location for the trial to move forward."
Answered by AI
What medical ailments are typically treated with Pulsed dye laser technology?
"Pulsed dye laser is frequently deployed in cases of inadequate responses to beta-blockers, and has been found beneficial for issues such as open angle glaucoma (oag), prophylaxis against migraine headaches, or serving as an adjunct or alternative treatment."
Answered by AI
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