EUCTR2009-009956-20-DE进行中（未招募）1 期
Prospective, randomized, controlled, mono-centric, two-armed, single-blinded pilot study for the treatment of venous and capillary vascular malformations by Indocyanine Green-augmented laser therapy - ICG-augmented laser therapy
Free State of Bavaria rep. by the Univ. of Regensburg, rep. by the Regensburg Univ. Hospital0 个研究点目标入组 0 人开始时间: 2009年3月17日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •- Written informed consent signed before or at Screening Visit by the patient (only adults).
- •- Caucasian patients of both sexes.
- •- Diagnosis of cutaneous venous and capillary vascular malformations at all sites of the skin except the hairy scalp.
- •- Distance between study lesion borders is = 0.5 cm.
- •- Skin sun sensitivity type I to IV according to Fitzpatrick.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •- Pre-treatment of cutaneous venous and capillary vascular malformations eligible for study procedures during the 12 weeks preceding study treatment (e.g. cryotherapy, radiotherapy, laser treatment).
- •- Treatment with systemic retinoids during the 3 months preceding study therapy.
- •- Female patients with a positive pregnancy test.
- •- Breast-feeding female patients.
- •- Patients with clinically relevant suppression of the immune system.
- •- Patients with non-controllable thyroid malfunction, for which administration of iodine is contraindicated.
- •- Patients with an allergy against iodine.
- •- Patients with severe liver malfunction.
- •- Skin diseases that might interfere with response evaluation of study treatment.
- •- Skin sun sensitivity type V or VI according to Fitzpatrick.
- •- Proven sensitivity or adverse reactions to one or more of the ingredients of ICG.
- •- Dementia or psychic conditions that might interfere with the ability to understand the study and thus give a written informed consent.
- •- Planned extensive UV-exposure (UV-phototherapy, vacation, tanning studio) in the first 2 months after treatment.
- •- Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion.
- •- Suspected lack of compliance.
- •- Uncooperative patients.
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