A Double-blind Placebo Controlled Trial Using Subcutaneous Injections of Intron A for the Treatment of Hypertrophic Scar
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Systemic effect of Intron A on hypertrophic scar
研究概览
简要总结
This study assesses the intervention with antifibrotic agents, specifically interferon (IFN) to reduce the magnitude and duration of hypertrophic scar. Burn patients with hypertrophic scar are randomly assigned to either an intervention IFN group or a placebo control group by subcutaneous injection three times a week. Patients are assessed using cutometer, mexameter, standardized photography, urinalysis, blood work, tissue biopsies and the Vancouver Burn Scar Assessment (VBSA) which rates selected HTS based on color, vascularity, height, pliability, itchiness and pain sensitivity. Once on treatment patients are assessed monthly for the six month treatment period.
详细描述
Burn patients being followed and treated in the Outpatient Burn Clinic with large areas of HTS are approached to participate in the study. Patients who agree to participate and who have signed an informed consent are entered into the trial.
Pre-treatment evaluation and monthly examinations include:
- standardized photographs of scar
- scar volume
- Vancouver Burn Scar Assessment (VBSA)
- blood work (TGF-beta, histamine)
- urine collection (histamine)
- 6mm punch biopsy of HTS and adjacent normal skin (every two months)
Patients are randomized to received with placebo or Intron A 1x106 IU a day for 7 days, then 3x106 IU 3 SC, three times a week for 23 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •burns > 5% tbsa
- •informed consent
- •no prior exposure to interferon or other cytokines
排除标准
- •history of cardiac or CNS disorder or disease
- •autoimmune disease
- •immunodeficiency
- •abnormal renal or hepatic function
- •pregnancy
- •serious intercurrent illness
- •active infection
- •malnutrition
- •active drug or alcohol abuse
研究组 & 干预措施
interferon alpha 2b (Intron A)
1 million IU of interferon alpha 2b (Intron A) subcutaneously once a day for 7 days, then 3 million IU of interferon alpha 2b (Intron A) subcutaneously three times a week for 23 weeks.
干预措施: interferon alpha 2b (Drug)
Placebo
Placebo administered subcutaneously once a day for 7 days, then three times a week for 23 weeks.
干预措施: interferon alpha 2b (Drug)
结局指标
主要结局
Systemic effect of Intron A on hypertrophic scar
时间窗: once / month for 6 months
standardized photographs of scar, scar volume, Vancouver Burn Scar Assessment (VBSA), blood work (TGF-beta, histamine), urine collection (histamine), biopsy of HTS and adjacent normal skin.
次要结局
未报告次要终点
研究者
Ted Tredget
Principal Investigator
University of Alberta