NCT01873131Toboroz
A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn
Preventing Growth of Hemangioma Tumors in Newborn: A Prospective Randomized Clinical Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2023. nov. 2. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 126 (tervezett)
- Első benyújtás
- 2012. aug. 20.
- Kezdés
- 2011. febr.
- Elsődleges befejezés
- 2025. dec.
- Fő szponzor
- Massachusetts General Hospital
- Betegségek
- Gyermekkori daganatok
- NCT-szám
- NCT01873131
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 126
- 2011. febr. és az elsődleges befejezés (2025. dec.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Infants already on other treatment prior to PDL or timolol treatments (including topical, systemic steroids or other agents)
- 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.
Más betegség
- 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
- Scarring or infection of the area to be treated
Egyéb
- Infants with hemangiomas that threaten vital functions (e.g. obstructing the airway or impairing hearing or vision)
- Subjects who are immunocompromised
- Subject whose parent/guardian is unable to comply with treatment, home care or follow-up visits
Kiket keres a vizsgálat
- Subjects aged less than 3 months, male or female.
- Infant with one or more superficial hemangiomas in the preproliferative phase or very early proliferative growth phase.
- Absence or minimal appearance of the lesion at birth
- More pronounced appearance within 1 month of birth.
- Willingness of parent/guardian to participate in the study
- Willingness of parent/guardian to receive EXPERIMENTAL treatment
- Informed consent agreement signed by the parent/guardian
- Willingness of parent/guardian to follow the treatment schedule and post treatment care requirements
- 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.
Életkor a regiszterben: - – 3 hónap · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Massachusetts General Hospital | Boston | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.