NCT01446770已完成2 期
A Prospective, Randomized, Comparative Feasibility Study Evaluating the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181 Adjunctive to Surgical Scar Revision
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Device safety
研究概览
简要总结
The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 15 to 50 years of age each having at least one keloid scar on the ear. (If both ears have keloids, both ears may be treated with E-Matrix).
- •Keloids that have not undergone more than two surgical revisions (laser, cryotherapy or surgery)
- •Keloids that have been present for ≥ 1 year.
- •The keloid must measure ≥ 0.5 cm and not extend onto other portions of the head, neck, or face.
- •Able and willing to give written informed consent. (Age 15-17 must have written informed consent of legal guardian).
- •Willing to comply with the follow up schedule for a minimum of 6 months.
排除标准
- •Subjects with history of prior treatment at the study site or prior treatment of the keloid in the previous 6 weeks.
- •Pregnant or planning to become pregnant during the course of the study.
- •Heart disease or history of congestive heart failure.
- •Advanced or poorly controlled diabetes.
- •Current or history of heavy smoking (i.e., 10 pack years)
- •Active local infection at the treatment site and/or systemic infection.
- •History of or active central nervous system disease.
- •History of fever, migraine headaches, and/or recurrent upper respiratory infection.
- •Active collagen vascular disease or vasculitis, e.g., systemic lupus erythematosus, polyarthritis, dermatomyositis, systemic scleroderma or thrombotic thrombocytopenic purpura.
- •Unwilling or unable to return for follow-up visits.
- •Unwilling to refrain from use of any other scar treatment therapy/scar improving product, during the study, including steroid injections.
- •Regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated.
- •Current participation or participation within the last 3 months in the study of an investigational drug, device, or biologic.
- •Unable or unwilling to follow post-operative instructions.
- •Known hypersensitivity to MF-4181, collagen, dextran, or any of its constituent materials.
- •Known hypersensitivities to animal-based products
- •Previous participation in this study to avoid multiple enrollments of an individual subject.
结局指标
主要结局
Device safety
时间窗: 6 months
Device safety is defined as the incidence of device related adverse events.
次要结局
- Device efficacy(12 months)
研究者
研究点 (2)
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