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
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