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Hemangioma, Capillary clinical trials

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NCT ID: NCT01101360 Completed - Port Wine Stains Clinical Trials

Port Wine Stains Treatment Matrix RF Study

Start date: March 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port Wine Stains based on clinical and histological analyses.

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: NCT01072045 Completed - Hemangioma Clinical Trials

Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Infantile Hemangioma

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

Infantile Hemangioma (IH) is infancy's most common vascular tumor of infancy and most frequent benign neoplasm. Treatment of IHs is indicated for approximately 10 to 20% of the cases. Two groups can be defined amongst indications for treatment: patients with absolute indication for treatment and patients with relative indication for treatment. Absolute or emergency indications comprise function or life threatening situations such as obstruction of airways, obstruction of vision, congestive heart failure, hepatic and coagulation problems. The following are considered relative indications: cases of large and disfiguring facial hemangiomas; locations that can result in a deformity and/ or permanent scar (nose, ear, lip, glabellar area); extensive face hemangiomas, mainly when there is dermal damage (more probable to scar); local complications such as ulceration, infection and bleeding as well as small hemangiomas in exposed areas (hands and face), mainly if pedunculated due to its ease of excision2,7. Treatment modalities vary according to the extension, location, presence of complications and the evolutional phase. A combination of various treatments is possible. Beta blockers are being used in children for approximately 40 years, with proven clinical safety and no cases of death or cardiovascular disease resulting from its direct use. Recently it was reported the use of beta blockers (propanolol) for IH treatment, with significant reduction of tumor volume after introduction of the beta blocker, in a short period of time, with stable results after the end of treatment, which suggested evidences of the benefits of this drug in the tumor treatment The proposal of this study is to assess the use of propanolol in IH treatment, quantifying its effectiveness and safety under continuous monitoring and comparing it to the use of oral corticosteroid. The investigators propose the assessment of the betablockers' use in comparison to the use of corticosteroids in infants with IH in the proliferative or involuting phases, with indication for clinical treatment, and that are not alarming nor urgent; in other words, the current relative indications for treatment.

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: NCT01056341 Completed - Clinical trials for Infantile Hemangioma

Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

Start date: January 2010
Phase: Phase 2/Phase 3
Study type: Interventional

There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

NCT ID: NCT01010308 Completed - Clinical trials for Infantile Hemangioma

Nadolol for Proliferating Infantile Hemangiomas

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

The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of infancy. The secondary objective is to assess the feasibility of conducting a randomized controlled trial comparing nadolol with corticosteroids and propranolol.

NCT ID: NCT00979550 Terminated - Port Wine Stains Clinical Trials

The Effects of Aldara as an Adjunct to Laser Treatment

Start date: October 2008
Phase: Phase 2
Study type: Interventional

The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.

NCT ID: NCT00974129 Withdrawn - Hemangioma Clinical Trials

A Study of CCCTC-binding Factor (CTCF) in Infantile Hemangiomas

Start date: September 2009
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the genotype of CTCF, a proven transcription factor, in patients with infantile hemangiomas and to monitor tumor growth. The investigators aim to determine whether or not the CTCF genotype might serve as an early and reliable predictor of tumor growth.

NCT ID: NCT00969397 Withdrawn - Port Wine Stain Clinical Trials

Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

Start date: November 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.

NCT ID: NCT00830466 Completed - Port Wine Stain Clinical Trials

A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.

Start date: December 2008
Phase: Phase 1
Study type: Interventional

The researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care. This single center pilot and feasibility study will have a target enrollment of 40 port wine stain subjects at the Beckman Laser Institute and Medical Clinic, University of California, Irvine.