NCT01704209终止1 期
Pilot Study of Autologous Fibroblast Injection for Acne Scars, Forehead Lines, Lip Lines, Horizontal Neck Lines, and Static Crow's Feet
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change from baseline of rater's comparisons at 6 months
研究概览
简要总结
The purpose of this study is to find out if autologous (your own) fibroblast injections are effective for the treatment of acne scars and wrinkles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Age 18 or over
- •Bilateral acne scars or have moderate to severe wrinkles
- •Subjects in good health
- •Subjects has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator
排除标准
- •Under 18 years of age
- •Pregnancy or lactation
- •recent Accutane use in the past 6 months
- •prone to hypertrophic and keloidal scarring
- •have excessively redundant skin in the treatment area or wrinkles longer than 20 cm total
- •have a history of autoimmune disorders, organ transplantation, cancer not in remission, active or chronic skin disease
- •have a history of basal-cell carcinoma
- •have previously received autologous fibroblast treatment
- •have undergone any confounding therapy in the lower two-thirds of the face within 1 year or any investigational treatment within 30 days.
- •have an allergy to collagen, bovine products, local anesthetics, gentamicin, or amphotericin B
- •subjects who are unable to understand the protocol or to give informed consent
- •subjects with mental illness
研究组 & 干预措施
Fibroblast Treatment
Experimental
The fibroblast treatment will be randomly injected into one side of the face.
干预措施: Fibroblast Treatment (Drug)
Vehicle
Placebo Comparator
The vehicle will be injected randomly to the other side of the face.
干预措施: Vehicle (Procedure)
结局指标
主要结局
Change from baseline of rater's comparisons at 6 months
时间窗: Basline and 6 months
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation
Northwestern University
研究点 (1)
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