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Port Wine Stain clinical trials

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NCT ID: NCT06080724 Completed - Clinical trials for Comparison of Efficacy of Sclerotherapy in Infantile Hemangioma

Efficacy of Intralesional Bleomycin Alone and in Combination With Dexamethasone in Infantile Haemangiomas

hemangioma
Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Objective: This study is intended to compare the outcome of intralesional bleomycin with dexamethasone versus the bleomycin alone in infantile haemangioma. Materials and Methods: This RCT was performed after the ethical approval at the pediatric surgery department of KEMU/Mayo hospital Lahore. 114 patients were enrolled in two groups A and B. Both groups contained 57 patients each. Group A was administered intralesional bleomycin with dexamethasone and group B was given intralesional bleomycin alone with a space of 4 weeks. Selection of patients was made according to inclusions and exclusion criteria.

NCT ID: NCT05080868 Completed - Clinical trials for Hemangioma, Capillary

Infantile Hemangioma With Minimal or Arrested Growth : Epidemiology, Clinical Characteristics and Evolution

Start date: March 23, 2021
Phase:
Study type: Observational

Infantile hemangioma (IH) is the most common vascular tumor of infancy, characterized by its clinical history. Absent at birth or present under the form of a premonitory mark, they display a rapid proliferative phase starting in the first weeks of life. Then, after a plateau phase, they slowly involute. However, a subtype of IH named "abortive", "minimal or arrested growth", "reticular" or "telangiectatic" hemangioma differs from typical IH because it doesn't have a proliferative component, or only a minimal one. This subtype of hemangioma has been recently described and data are lacking regarding its proportion among infantile hemangioma and its differences with "classic" infantile hemangioma. The aim of this study is to estimate the proportion of abortive hemangioma among infantile hemangioma. Also, the investigators aim to compare the clinical characteristics of "classic" infantile hemangiomas and abortive hemangiomas. Lastly, investigators wished to study the evolution of abortive hemangioma.

NCT ID: NCT04999618 Completed - Vascular Diseases Clinical Trials

A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology

DOUBLE-SKIN
Start date: January 1, 2020
Phase: Phase 4
Study type: Interventional

Laser treatment (LT) is the first-line treatment for Vascular Pathology. However even when LT is based on the selective photothermolysis it causes the first-degree burns. While being typically benign by affecting only the epidermis, or outer layer of skin, the burn site is remaining red, dry, and very painful. As Haemoblock contains nanoparticles of silver and is known for both bactericidal and bacteriostatic effects, it likely decreases the potential for infection postoperatively. Furthermore, after fibrin replaces the superficial structure "Hemoblock-albumin", the polyacrylate matrix is plasmolyzed which initiates the cascade of signals required for the tissue regeneration processes. Objective of the study was to examine the effect of the Regenerative Solution "Hemoblock" in lowering postoperative complications in children diagnosed with Vascular Pathology undergoing a laser surgery if delivered with transdermal patches.

NCT ID: NCT04651049 Completed - Clinical trials for Infantile Haemangiomas

Systemic Propranolol for the Treatment of Paediatric Patients With Infantile Hemangiomas

Start date: July 15, 2010
Phase:
Study type: Observational

This is retrospective study. The patients treated with oral propranolol at a dose of 2.0 mg/kg per day. Growth parameters (height and weight) were measured at the beginning, the end of treatment and 2 years after treatment. The weight-for-age Z-score (WAZ), height-for-age Z-score (HAZ) and weight-for-height Z-score (WHZ) calculated by the WHO Anthro software were used to assess physical development, and the WHO Child Growth Standards were used as the standards.

NCT ID: NCT04106258 Completed - Port-wine Stain Clinical Trials

A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain

Start date: May 27, 2020
Phase: Phase 4
Study type: Interventional

This pilot study aims to evaluate the safety and efficacy of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS)in 2-7 years old children. The pharmacokinetic behavior and pharmacokinetic parameters of hemoporfin in children will be investigated as well.

NCT ID: NCT04105517 Completed - Clinical trials for Infantile Hemangioma

Hemangiol, Post Marketing Surveillance Study

postHemangiol
Start date: July 1, 2019
Phase:
Study type: Observational

Infantile hemangioma is a benign tumor belonging to the group of vascular tumors in the ISSVA classification (International Society for the Study of Vascular Anomalies). The diagnosis is clinical and radiological. The hemangioma appears during the first weeks of life (70% classically within 2 weeks after birth) but can, when it develops in the subcutaneous tissue, appear until the age of 2 to 3 months . Its evolution is characteristic and is divided into 3 phases with a proliferative phase characterized by a rapid increase in the size of the tumor (up to 6 to 12 months), a phase of stabilization (from 12 to 36 months) with a stopping of the growth of the hemangioma and a regression of its size and a phase of involution with the disappearance of the lesion which may give way to residual fibroadipose tissue, cutaneous telangiectases, scars … The usual complications of haemangiomas occur during the proliferative phase. It is necrosis, ulcerations that can be complicated by bleeding or infection and eventually indelible scarring. Other complications related to the site of development of hemangiomas (amblyopia, astigmatism, upper respiratory obstruction, nasal obstruction, sphincter disorders, eating disorders), hemangiomas destroying structures noble (breast hypodévelopment, alopecia). The aesthetic prognosis can be seriously compromised for facial locations. Historically, when drug therapy was required, patient management was based on systemic corticosteroids (at doses of 3 to 5 mg / kg / day) in first-line therapy and vincristine as a second-line failure of corticosteroid therapy or when life-threatening is at stake. In 2014, the high French health authority (HAS) gave Marketing Authorization for Hemangiol 3.75 mg / ml oral solution for the management of infantile proliferative hemangioma requiring first-line systemic treatment, evaluating the actual benefit as important. The selected indication concerns children from 5 weeks to 5 months with: - Hemangiomas leading to a vital or functional risk, - Hemangiomas ulcerated painful and / or not responding to simple care, - Hemangiomas with a risk of permanent scarring or disfigurement. The 2014 HAS Transparency Commission wishes in its report "to have follow-up data of prescriptions allowing to describe on a representative sample of patients, the characteristics of the treated patients, the indication, the doses and the durations of treatment of this specialty ". The objective of our study is to describe the use of Hemangiol in current practice in our hospital from 2014 to 2018.

NCT ID: NCT03948997 Completed - Port Wine Stain Clinical Trials

The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

1. Port wine stain (PWS) is a congenital, progressive vascular malformation of human skin involving the superficial vascular plexus that occurs in estimated 3-5 children per 1,000 live births. In childhood, PWS are flat red macules, but lesions tend to darken progressively to purple and, by middle age, often become raised as a result of the development of vascular nodules. Because most malformations occur on the face, PWS is a clinically significant problem in the majority of patients. 2. The late-stage cobblestoning appearance of PWS subjects is comprised by not only pronounced vascular ectasia with proliferation of thin and/or thick-walled vessels and their stroma, but also numerous epithelial, neural and mesenchymal hamartomatous abnormalities. Despite these histologic observations, the specific mechanisms involved in PWS nodular formation remains unclear. 3. In one nodular PWS subject, we found that phosphatidylinositol 3-kinases (PI3K)/protein kinase B (AKT) and phosphoinositide phospholipase C g subunit (PLC-g) were activated in both hypertrophic areas and nodules within the lesion. These observations led us to hypothesize that the PI3K pathway may play an important role in nodular formation.

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: 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.