EUCTR2011-003144-50-FR进行中（未招募）1 期
A randomised, double blind, controlled, multicentre study in infants with infantile hemangioma to compare propranolol gel to placebo
Pierre Fabre Dermatologie, Represented by Institut de Recherche Pierre Fabre0 个研究点目标入组 80 人开始时间: 2011年9月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •A patient will be eligible if he/she meets all of the following criteria:
- •Written informed consent(s) for study participation and the use of the patient’s images are obtained according to national regulations from the patient’s parent(s) or legal guardian(s) prior to performing any study procedures.
- •The patient is 35 to 150 days old inclusive, at inclusion.
- •Only one proliferating IH is present anywhere on the body except on the head, the neck, the hands and on the diaper area, with largest diameter = 1cm and = 3 cm.
- •If required by national regulations, patient registered with a social security or health insurance system and/or whose parent(s) or legal guardian(s) is (are) registered with a social security or health insurance system.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient will be ineligible if he/she meets any of the following criteria:
- •The patient has got more than one IH with largest diameter = 1cm
- •The patient has a medically unstable health status that may interfere with his/her ability to complete the study.
- •IH requires, according to Investigator’s judgment, a systemic treatment.
- •The patient is known to have one or more of the following medical conditions: bronchial asthma; bronchospasm; hypoglycaemia; untreated phaeochromocytoma; hypotension; second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia; severe peripheral arterial circulatory disturbances; Raynaud’s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal’s angina.
- •The patient has received at least one of the following prohibited medications within 14 days before randomisation:
- •- Cardiovascular treatments: anti-arrhythmics, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators (hydralazine hydrochloride…), clonidine…
- •- Hypoglycaemic agents or drugs able to induce hypoglycaemia.
- •- Non-steroid anti-inflammatory drugs (NSAIDs) at anti-inflammatory dose.
- •- Sympathomimetic agents and parenteral adrenaline.
- •The patient has previously been administered systemic, intralesional or topical corticosteroids, vincristine, alfa-interferon, imiquimod, propranolol or other beta-blockers.
- •The patient has previously been administered treatment for IH or surgical and/or medical procedures (e.g. laser therapy) have been performed to treat the IH.
- •The patient’s mother has been breastfeeding the patient while she was also being treated with beta-blockers (including propranolol) or, she has been breastfeeding the patient within 14 days of randomisation while she was also being treated with systemic (oral, intra-venous or intra-muscular) corticosteroids, vincristine or alfa-interferon.
- •The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers and/or any ingredient of the test product.
- •Patient with congenital hemangioma
- •Patient with ulcerated IH.
- •Patient with heart rate < 80 bpm at inclusion
- •Patient with blood pressure < 50/30 mmHg at inclusion
- •Patient with known renal impairment.
- •Patient with known cardiac conditions that may predispose to heart block.
- •The patient is participating in another clinical study or has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial.
- •The patient has sibling already participating to this clinical study
- •Parent(s) or legal guardian(s) who cannot be contacted by telephone in case of emergency.
研究者
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