NCT03282994已完成不适用
Evaluation of the Dermal Cooling System for Cryotherapy of Common Skin Conditions
R2 Dermatology6 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年7月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Improvement in appearance in the treatment area
研究概览
简要总结
Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.
详细描述
The purpose of this study is to establish that controlled localized cooling with the Dermal Cooling System will elicit an improvement in the cosmetic appearance of benign superficial lesions associated with common skin conditions that are currently being treated with cryosurgical methods.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects > 18 years of age.
- •Subject has benign superficial lesion(s) associated with common skin conditions amenable to cryosurgical treatment including, for example, psoriasis, acne, rosacea, and sebaceous hyperplasia.
- •Subject is willing to have up to 40 test sites treated.
- •Subject has read and signed a written informed consent form.
排除标准
- •Physician prescribed procedures in the area of intended treatment in the previous 6 months (e.g., photodynamic therapy, intense pulsed light therapy, laser surgery).
- •Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous or malignant lesions) in the location of the treatment sites that would, in the professional opinion of the investigator, potentially pose an increased risk to the subject.
- •History of melanoma.
- •Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
- •History of abnormal wound healing or abnormal scarring
- •Inability or unwillingness to comply with the study requirements.
- •Subject is pregnant or planning to become pregnant while enrolled in the study.
- •Subject is lactating.
- •Current enrollment in a clinical study of any other unapproved investigational drug or device.
- •Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an increased or unacceptable risk to the subject.
结局指标
主要结局
Improvement in appearance in the treatment area
时间窗: 3-months
Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA).
次要结局
- Incidence of procedure related adverse events(less than 12 months)
研究者
研究点 (6)
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