NCT03631368Unknown2 期
Treatment of Hypertrophic Scars With Intradermal Botox
Roy G. Geronemus, M.D.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale
研究概览
简要总结
This is a prospective, open label, single center, self-controlled clinical study to demonstrate the safety and efficacy of intradermal botulinum toxin in treating hypertrophic scarring.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy female and male subjects between the ages 18-
- •Non-Smoker.
- •Fitzpatrick skin type I-VI.
- •Desire to improve hypertrophic scarring.
- •Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
- •Able to understand and provide written Informed Consent.
排除标准
- •Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- •Presence of any active systemic or local infections.
- •Presence of active local skin disease that may alter wound healing.
- •Known allergy to botulinum toxin.
- •History of smoking in past 10 years.
- •History of chronic drug or alcohol abuse.
- •Inability to understand the protocol or to give informed consent.
- •History of cosmetic treatments in the area to be treated, including injectable filler of any type within the past year; Botox in the treatment area within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep peels within the past 6 months; surgery to the area within the past 6 months.
- •History of intralesional corticosteroids or any other injectable medication to the area within the last 3 months.
- •History of topical corticosteroids to the area within the past 4 weeks.
- •History of any musculoskeletal disease or any weakness in the area to be treated.
- •As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
研究组 & 干预措施
Botox
Experimental
干预措施: Botox (Drug)
结局指标
主要结局
Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale
时间窗: change from baseline at 6 months after treatment
次要结局
未报告次要终点
研究者
Roy G. Geronemus, M.D.
Principal Investigator
Laser and Skin Surgery Center of New York
研究点 (1)
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