Intralesional Bleomycin Treatment of Keloids Using an Electronic Pneumatic Jet Injector: a Double-blind Randomized, Placebo-controlled Trial With Split-lesion Design
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Volume reduction
研究概览
简要总结
This is a single center, double-blind (patient and investigator), randomized, placebo-controlled study with a split-lesion design, in which selected keloids will receive three consecutive treatments of a) bleomycin and b) placebo (saline (NaCl 0,9%)), administered with an electronic pneumatic jet injector.
详细描述
This is a single center, double-blind (patient and investigator), randomized, placebo-controlled study with a split-lesion design.All study procedures will be performed at the Department of Dermatology, Erasmus MC Medical Center in patients referred for scar treatment to our outpatient clinic.
Clinical photos will be obtained after signing the informed consent form by patient and investigator. Study visits and clinical assessments will be scheduled at baseline, 4 weeks, 8 weeks, and 12 weeks. Measurements include clinical photography, scar volume measured by 3D-camera, POSAS questionnaire, laser speckle contrast imaging to visualize keloid scar vascularization, measurement of residue formation on the skin, and a treatment related questionnaire. The keloid will be divided into two treatment areas, and randomly assigned to three consecutive treatments of: a) bleomycin and b) placebo (saline (NaCl 0,9%)), administered with an electronic pneumatic jet injector.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informed consent;
- •Subject is ≥ 18 years of age at time of screening;
- •Subject has at least one keloid scar of ≥ 4 cm in length, or two separate keloids with a length of ≥2cm, with a minimum > 1.0 cm apart in the same anatomical region.
- •Subject is willing to fill in questionnaires and take photos using an e-diary application on their phone.
排除标准
- •Known hypersensitivity to any component of the test materials;
- •Pregnant or breast-feeding women (pregnancy test prior to treatment);
- •Previous bleomycin treatment of the keloid within the last 12 weeks prior to screening.
- •Non-response to previous bleomycin treatments of the keloid.
- •Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
研究组 & 干预措施
Bleomycin jet-injections
This study consists of a split-lesion design in which the keloid scar will receive three consecutive treatments with an interval of 4 weeks of: 1) bleomycin and 2) placebo (NaCl 0,9%), administered with an electronic pneumatic jet injector. A single injection of 100 μL will be given per 1 cm2, with a maximum of 20 injections per treatment. The maximum dosage of bleomycin per treatment will be 2 mL, corresponding to 2 USP-E (units) of bleomycin. The maximum cumulative dosage of bleomycin will be 6 USP-E in this study.
干预措施: Bleomycin (Drug)
Placebo jet-injections
This study consists of a split-lesion design in which the keloid scar will receive three consecutive treatments with an interval of 4 weeks of: 1) bleomycin and 2) placebo (NaCl 0,9%), administered with an electronic pneumatic jet injector. A single injection of 100 μL will be given per 1 cm2, with a maximum of 20 injections per treatment. The maximum dosage of normal saline per treatment will be 2 mL.
干预措施: Normal saline (Drug)
结局指标
主要结局
Volume reduction
时间窗: 12 weeks
Volume reduction of scar tissue in mm\^3.
次要结局
- Clinical efficacy using Patient and Observer Scar Assessment Scale (POSAS)(12 weeks)
- Vascular perfusion(12 weeks)
- Residue formation on skin(30 minutes)
- Procedure related pain(30 minutes)
- Local skin reactions(12 weeks)
- Treatment satisfaction(12 weeks)
- Incidence of Treatment-Emergent Adverse events [Safety and Tolerability].(12 weeks)
研究者
M.B.A. van Doorn
Principal Investigator
Erasmus Medical Center