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Hemangioma clinical trials

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NCT ID: NCT04336163 Terminated - Rosacea Clinical Trials

Skin Imaging to Inform Laser Treatments

Start date: September 20, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to obtain information (such as lesion depth, depth of the most superficial part of the lesion, and the size and density of blood vessels) with the assistance of an imaging device, and use this information to assist in selection of laser settings for the treatment of skin conditions. The imaging modality is called Optical Coherence Tomography (OCT). Multiple laser modalities will be used, including intense pulsed light lasers (BroadBand Light, Profractional Sciton), pulsed dye lasers (Vbeam Perfecta, Candela), long-pulse 755nm lasers (GentleLASE, Candela), Sciton long-pulse 1064nm lasers, and non-ablative and ablative fractional resurfacing lasers (Profractional, Sciton). All of the lasers noted above are the only ones that will be used in this study. These lasers have 510k clearance and are being used as per their approved indications in this study. The choice of laser type is based on the skin lesion and is recommended by the physician, and the subjects who are going to enroll in this study will already be planned to undergo laser treatment as a standard of care for their condition. This is a pilot study that will explore the utility of skin imaging in guiding the laser treatment of skin lesions.

NCT ID: NCT04020419 Terminated - Hemangioma Clinical Trials

Natural Berry Extract Treatment of Hemangiomas

Pediaberry
Start date: December 1, 2020
Phase: Early Phase 1
Study type: Interventional

This is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of PediaBerry for the treatment of hemangiomas in infants ≤ 4 months of corrected gestation age over a 6-month treatment period. Subjects will be followed to age 18 months. A total of 44 subjects will be PediaBerry group and 22 subjects in the placebo control group.

NCT ID: NCT02110069 Terminated - Tufted Angioma Clinical Trials

A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors

Start date: June 14, 2017
Phase: Phase 2
Study type: Interventional

In this research study we want to learn more about which treatment works better for patients diagnosed with a vascular tumor called Kaposiform Hemangioendothelioma (KHE) or other high risk vascular tumors such as Tufted Angioma (TA). In these tumors, the blood cells that help your blood clot called platelets become trapped in the tumor causing swelling, pain, and bruising. Vascular tumors can be life threatening. There are few medical treatments that will work to shrink the vascular tumor. Some doctors will use steroids and vincristine to try and shrink vascular tumors. In this research study, the study doctor will compare two different drugs to see which one will work better to help shrink your vascular tumor. One of the drugs is vincristine. Vincristine is approved by the Food and Drug Administration (FDA) to treat people with cancer. Vincristine is used to stop the abnormal cells from growing such as cells that make up blood vessels. The other drug to be used in this study is sirolimus. Sirolimus is currently approved by the Food and Drug Administration (FDA) to prevent transplanted organ rejection. Sirolimus is not approved by the FDA for treatment of vascular abnormalities and is considered experimental. Sirolimus belongs to a class of drugs call 'mTOR inhibitors'. mTOR (mammilian target of rapamycin) helps cells to grow and may also help blood vessels to grow in a more normal fashion. Sirolimus is currently being tested in patients with vascular tumors and cancer. In vascular tumors, we hope sirolimus will stop the blood vessel growth. Funding Source: FDA - OOPD (Office of Orphan Products Development)

NCT ID: NCT01801488 Terminated - Clinical trials for Subarachnoid Hemorrhage

Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm

Start date: November 2011
Phase: N/A
Study type: Observational

Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to identify a genetic difference between the two types of aneurysms; and to test SNP's in arteriovenous malformation tissue to identify a genetic link.

NCT ID: NCT01764451 Terminated - Clinical trials for Cerebral Cavernous Malformations

Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins

Start date: March 2012
Phase: Early Phase 1
Study type: Interventional

Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of this barrier can cause disease. We will measure the permeability (leakiness) of the BBB using a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI (DCEMRI). The purpose of this study is to look at whether statin medications change the permeability (leakiness) of the blood brain barrier in CCM patients. Statin medications are used to lower cholesterol levels and prevent heart attack and stroke. In addition, this medication may decrease the risk of brain hemorrhage or bleeding in patients with CCM. This study will examine whether the permeability of the BBB changes following the administration of simvastatin for three months.

NCT ID: NCT01743885 Terminated - Hemangioma Clinical Trials

Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma

Start date: November 2012
Phase: Phase 3
Study type: Interventional

There is no effective treatment for hemangioma regardless of immediate severity. That is in this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of proliferation of several months (very scary for parents) and regression over several years. The natural history is peppered with local complications (ulcers) and aesthetic and psychological sequelae (sometimes major for the child and the family). The effects of acebutolol and propranolol on the proliferative hemangiomas were discovered accidentally by two French teams (Montpellier for acebutolol and Bordeaux for propranolol). Acebutolol and propranolol have been used for many years for the treatment of hypertension and congenital heart disease, including infants, with few side effects. The effects of acebutolol and propranolol were immediately visible with reduced volume and skin whitening of the hemangioma. In a preliminary study, acebutolol was administered to 20 patients in Montpellier with big regression of hemangiomas. The aim of the study was to compare the clinical efficacy of acebutolol (10mg/Kg/jour) and propranolol (3mg/Kg/j) on the proliferative phase of infantile hemangioma in infants.

NCT ID: NCT01434849 Terminated - Clinical trials for Very Low Birth Weight Infants

Timolol for the Prevention of Proliferation of Infantile Hemangioma (TiPPIH Trial)

TiPPIH
Start date: July 2012
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to see if a topical beta blocker is effective in preventing the proliferation of infantile hemangioma.

NCT ID: NCT01074437 Terminated - Hemangioma Clinical Trials

Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This is a prospective randomized, double-blind study to compare the clinical efficacy of infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy with corticosteroids and placebo. We hypothesize that a two-month treatment period with propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and vascularity when compared to corticosteroids used without propranolol for the same time period.

NCT ID: NCT01059045 Terminated - Clinical trials for Hemangioma of Preterm Infants

Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants

Start date: August 2004
Phase: N/A
Study type: Interventional

Prospective controlled study evaluating cryocontact therapy of infantile hemangiomas of preterm infants Principal investigator: Rangmar Goelz, MD Coworkers: M Möhrle, M Moll, HM Häfner, W Schippert, C Meisner, M Röcken, CF Poets Background Despite their frequent occurrence, there is no established therapeutic procedure for localized infantile hemangioma in preterm infants. A PubMed search with the key words hemangioma, controlled study, infant or childhood revealed five studies (1-5), none of them included preterm infants, even though low birth weight and prematurity have been described as the most significant risk factors Aim: To evaluate cryocontact therapy of infantile hemangioma (IH) of 1 - 10 mm diameter in preterm infants <=34 weeks of gestational age (GA) using a liquid nitrogen cooled metal at the Department of Neonatology at the Tuebingen University Hospital. Method: In a prospective controlled study, preterm infants <= 34 weeks GA with at least 2 IH should be randomized to have one treated with cryocontact therapy using a liquid nitrogen cooled metal (-196°C), while the other one is left untreated. Primary endpoint is an intact skin at the site of the hemangioma at 1 year corrected age . The study starts at August 1st, 2004. Cryocontact is done by 3 trained dermatologist (MM, HMH, WS), outcome documentation, including photodocumentation, by 2 neonatologist (RG, MoMo). Statistical Analysis: A sample size of 25 intrapersonal pairs of treated and untreated IH is needed to show a significant difference with alpha=0.05 and beta=0.9 between treated IH and controls, assuming that 5% of the treated IH and 40% of the controls have an unsuccessful primary outcome. Documentation will be made on standardized forms and the data will be transferred to Excel. Biometric calculations will be handled with SAS 9.1.3. for Windows using Fisher´s Exact Test for difference in proportions. Ethics: The study is approved by the Ethics Committee of Tuebingen University Hospital; all parents must give written informed consent.

NCT ID: NCT00967226 Terminated - Clinical trials for Hemangioma of Infancy

Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas

Start date: July 2009
Phase: Phase 2
Study type: Interventional

Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one year of life and do not need treatment. Others require treatment because they cause significant symptoms such as pain, or difficulty with breathing, eating or ambulating. Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have sought other ways to treat them. Recently, the use of propranolol, a heart medication, was serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side effects than steroids but it is not yet known if it works as well as steroids. This study seeks to compare the effect and the side effects of propranolol versus steroids for treating hemangiomas that cause symptoms in infants.