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临床试验/NCT04288700
NCT04288700Unknown4 期

Evaluation of the Efficacy of Captopril Versus Propranolol and Timolol as a Treatment of Infantile Capillary Hemangioma

Ain Shams University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
Assessment of serum levels of CD 133

研究概览

简要总结

Is to compare and evaluate the efficacy of oral captopril with oral propranolol, intralesional propranolol injection, and topical Timolol in the treatment of infantile hemangioma and their effect on vascular endothelial growth factor and CD 133.

详细描述

Infantile hemangiomas are the most common benign tumor of infancy, affecting up to 10% of the pediatric population with a higher incidence in female (3:1), preterm infants, and Caucasian population. The molecular mechanisms underlying pathogenesis remain incompletely understood, but the clinical course follows a stereotyped pattern: a phase of early vascular proliferation over the first year of life followed by a gradual phase (1 to7 years in duration) of spontaneous involution and replacement of vascular channels by fibro-fatty tissue. Despite their benign nature,in certain cases IHs can cause severe morbidities and therefore sometimes require medical intervention.

Vascular endothelial growth factor A is the predominant growth factor associated with endothelial proliferation, migration, and survival. Vascular endothelial growth factor, being a potent inducer of vascular permeability, is known to cause edema and lead to formation of hemangiomas in high concentrations along with CD133 is a transmembrane glycoprotein which represents a cell surface marker for hemangioma-derived stem cells (HemSCs). CD133-positive HemSCs can still be differentiated into hemangiomas, suggesting that CD133-positive HemSCs have continuous ability to form hemangiomas. Targeted elimination of CD133-positive HemSCs could fundamentally inhibit the proliferation of hemangioma.

Aim of the study is to compare and evaluate the efficacy of oral captopril with oral propranolol, intralesional propranolol injection, and topical Timolol in the treatment of infantile hemangioma and their effect on vascular endothelial growth factor and CD 133.

Methodology : Open label Randomized Controlled trail will be carried out at Vascular malformation clinic of Pediatric Surgery department of Ain Shams University ,Patients of the study will be randomly allocated equally into 4 groups (A, B, C, D), 25 patients each.

  • Group A: Subjected to oral propranolol therapy at a dose of 2 mg/kg/d in three divided doses.
  • Group B: Oral Captopril will be administered as a test dose of 0.1 mg kg orally with pulse rate and blood pressure monitored at 0.5, 1 and 2 h and at each follow up. If the test dose is tolerated, captopril administration will start at 0.15 mg/ kg) per dose 8-hourly. Pulse rate and blood pressure will be monitored 4-hourly and doses will be withheld if hypotension is documented. After 24 h, the dose will be increased to 0.3 mg/ kg) per dose 8-hourly.
  • Group C: Subjected to intralesional propranolol injection 1 mg/mL. The volume of injected drug depends on the size of the lesion (0.2 mL will be injected per cm of lesion diameter), with a maximum volume of 1 mL for a lesion of 5 cm diameter
  • Group D: Subjected to topical Timolol maleate 0.5% eye drops on the surface of the lesions three times daily and gentamycin ointment will be applied around the lesions to prevent the timolol from leaking.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients younger than 12 years and older than 2 months of age with infantile hemangioma

排除标准

  • Patient with ulcerated or infected hemangioma.
  • Patient younger than 2 months and older than 12 years of age.
  • Patients with multiple hemangiomas.
  • Any Patient with cardiovascular problems, bronchial asthma, diabetes mellitus, bilateral renal stenosis, Electrolyte disturbance, or renal impairment was excluded.
  • Patients with abnormal electrocardiogram, or echocardiogram should be excluded.
  • Patients who have had previous treatment for hemangioma.

研究组 & 干预措施

Group A

Active Comparator

干预措施: oral propranolol (Drug)

Group B

Active Comparator

干预措施: Oral Captopril (Drug)

Group C

Active Comparator

干预措施: intralesional propranolol injection (Drug)

Group D

Active Comparator

干预措施: topical Timolol maleate 0.5% eye drops (Drug)

结局指标

主要结局

Assessment of serum levels of CD 133

时间窗: 6 months

Assessment of serum levels of Vascular endothelial growth factor

时间窗: 6 months

Assessment of the size of the lesion.

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rana Mohamed El-Sayed Ibrahim Atta

Teaching Assistant, Pharmacy Practice and Clinical Pharmacy Department

Ain Shams University

研究点 (1)

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