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临床试验/EUCTR2019-001066-15-DK
EUCTR2019-001066-15-DK进行中(未招募)1 期

Treatment of hypertrophic scars using needle-free jet-injection of triamcinolone and 5-Fluorouracile: a prospective, controlled, randomized, single-blinded split-lesion trial.

Merete Hædersdal0 个研究点目标入组 20 人开始时间: 2019年4月5日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

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

  • Healthy patients above 18 years of age.
  • Patients presenting with hypertrophic scar (>4 mm in height)
  • The length of scar should be estimated to minimum 3.0 cm or two separate scars with a length of >1cm, with a minimum > 1.0 cm apart in the same body region
  • Non-smokers
  • Fertile women with negative U-hCG and with use of safe anticontraceptive during the entire study period e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation or hormonal vaginal ring
  • Written informed consent obtained from patient
  • 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 20
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • History of, or presenting with a keloid scar
  • If the patient is pregnant or lactating
  • use of topical treatment in the last 6 months and lack of willingness to refrain use during the trial as topical treatment, such as i.e. silicone potentially could interfere with the test results
  • Anti coagulatory treatment such as Warfarin, Heparin and NOAK.
  • Known allergy to the administered medications
  • Previous medical treatments of the HTS
  • Unable to follow the outlined study protocol

研究者

发起方
Merete Hædersdal

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