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Port Wine Stain clinical trials

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NCT ID: NCT03237637 Recruiting - Clinical trials for Infantile Hemangioma

Comparative Study to Evaluate the Effectiveness of Atenolol and Propranolol in the Treatment of Infantile Hemangiomas

Start date: March 24, 2017
Phase: Phase 3
Study type: Interventional

Through this study, the investigators shall compare the effectiveness of atenolol with propranolol in the treatment of IH. In addition, the investigators shall try to elucidate the mechanism of action of beta blockers by assessing their action on triggers such as hypoxia. The study design will be a parallel group comparative study wherein patients of IH will be randomized into two groups. One group will receive propranolol and the other atenolol for a maximum period of 9 months. The patients will then be followed up regularly for regression of the IH based on Physician global assessment, hemangioma activity score(HAS), serial photography and lesional ultrasonography. Any side effects encountered during the treatment period will also be noted. Also serial measurements of hypoxia inducible factor 1 alpha(HIF-1α) will be made to ascertain the mechanism of action of the drugs.

NCT ID: NCT03181984 Completed - Port-Wine Stain Clinical Trials

Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

Start date: August 31, 2017
Phase: Phase 4
Study type: Interventional

This study is to provide safety information of hemoporfin during the post-marketing period as required by China Food and Drug Administration (CFDA) regulations in order to identify any potential drug related treatment factors in the Chinese population, such as unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine drug uses.

NCT ID: NCT03173352 Recruiting - Clinical trials for Infantile Hemangioma

A Prospective Study on the Incidence and Related Risk Factors of Infantile Hemangioma in China

IH
Start date: December 2015
Phase: N/A
Study type: Observational

Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related epidemiological data remains unclear. So, the investigators designed the study for the following purposes: 1, to aware the incidence of infantile hemangioma and understand the related risk factorsin China; 2, to understand the clinical characteristics of infantile hemangioma and the risk factors for complications; 3, to investigate the level of knowledge, treatment options in infant hemangioma in Chinese doctors; 3, to improve the awareness of infantile hemangioma in parents and provide more advice for pregnancy counseling and eugenics.

NCT ID: NCT03125057 Completed - Port-wine Stain Clinical Trials

A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain

Start date: August 2, 2017
Phase: Phase 4
Study type: Interventional

This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS) in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well.

NCT ID: NCT02913612 Completed - Clinical trials for Infantile Hemangioma

Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)

TIM01
Start date: May 5, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5% doses.

NCT ID: NCT02883023 Recruiting - Clinical trials for Vascular Malformations

Electrosclerotherapy for Capillary Malformations

Start date: November 2016
Phase: Phase 2
Study type: Interventional

Capillary malformations (port-wine stains) consist of abnormally developed capillary blood vessels in the skin. To date, laser therapy is the only widely accepted treatment modality for capillary malformations, but this therapy has a suboptimal effect in approximately 50-60% of patients. Intralesional bleomycin injections (sclerotherapy) are a common effective treatment option for vascular malformations with blood vessels with larger diameters. However, bleomycin cannot be injected adequately in the small sized vessels of capillary malformations. The use of an electric field over the tissue (electroporation) may solve this problem: it increases cell membrane permeability and therefore promotes localized delivery of drugs, within (endothelial) cells. Electroporation in combination with bleomycin sclerotherapy ('electrosclerotherapy') may therefore offer new therapeutic options for capillary malformations. This proof of principle study aims to explore the effectiveness, safety and feasibility of this potential treatment option in a within-patient-controlled pilot study.

NCT ID: NCT02731287 Completed - Hemangioma Clinical Trials

Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

Start date: March 2014
Phase: Phase 2
Study type: Interventional

Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a non-selective beta-blocker, is an emerging treatment which has been reported to be effective and safe for the treatment of IH, especially for superficial hemangiomas. Investigators hypothesize that treatment with topical timolol in the first two months of life, before the proliferative phase or in early proliferative phase, may prevent from further growing and the need to treat with oral propranolol.

NCT ID: NCT02505971 Completed - Clinical trials for Infantile Hemangioma

Nadolol Versus Propranolol in Children With Infantile Hemangiomas

Start date: September 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of oral propranolol versus nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled, double-blinded study.

NCT ID: NCT02342275 Completed - Hemangioma Clinical Trials

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

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.

NCT ID: NCT02317679 Completed - Port-wine Stains Clinical Trials

Treatment of Resistant Port-wine Stains With Bosentan and Pulsed Dye Laser: a Pilot Study

Start date: April 2014
Phase: Phase 2
Study type: Interventional

Pulsed dye laser (PDL) is the gold standard treatment for port-wine stains (PWS). However, the outcomes are highly variable due to the new angiogenesis occurring after laser irradiation. Studies suggest that endothelin is involved in the neoangiogenesis that occurred after treatment of port-wine stains by PDL. The main objective of this pilot clinical trial is to evaluate the effectiveness and safety of an inhibitor of endothelin orally taken, the Bosentan, following PDL treatment. Four patients with facial port-wine stain resistant to the PDL treatment will be included. The treatment by Bosentan (2 mg/kg twice daily, maximum 62,5 mg twice daily) will be given one day before the PDL irradiation and continued for 14 days. Only one test area of PWS will be treated with PDL. The primary outcome measure will be an important or complete improvement (Investigator Global Assessment 3 or 4) between treated area and non treated one, 14 days after the end of the treatment which corresponds to one month after the laser PDL session. The evaluation will been performed on standardized pictures by 2 independent physicians blinded to the region treated or not.