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NCT01873131 · ClinicalTrials.gov registry record · NA
A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn
A NA study of Hemangioma, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 126
- Enrollment target
- 1
- Study location
NCT01873131 is a NA study of Hemangioma that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 126 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01873131, a NA study of Hemangioma, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG topical timolol maleate
- DEVICE Pulsed dye laser
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2011-02 |
| Est. Completion | 2028-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01873131
The ClinicalTrials.gov registry entry for NCT01873131 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemangioma appearing as the primary indexed condition, and to 2 interventions - of which topical timolol maleate is the first listed.
NCT01873131 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01873131 about?
NCT01873131 is a clinical study titled "A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn". 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. Hemang...
What is the current status of trial NCT01873131?
This trial is currently recruiting. It is a NA study. The enrollment target is 126 participants. The study started on 2011-02. Estimated completion is 2028-12.
What conditions does trial NCT01873131 study?
This clinical trial studies the following conditions: Hemangioma.
What interventions are being tested in trial NCT01873131?
The interventions under investigation include: topical timolol maleate (DRUG), Pulsed dye laser (DEVICE).
Who is sponsoring clinical trial NCT01873131?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01873131 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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