Evaluation of the Dermal Cooling System for Treatment of Common Skin Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 8
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms of common skin conditions.
详细描述
This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to determine if cosmetic benefits or physical symptoms are achieved in common skin conditions.
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 a skin condition amenable to cryosurgical treatment including, for example, psoriasis, atopic dermatitis, acne, rosacea, and melasma.
- •Subject is willing to have skin exposed to cooling with the Dermal Cooling System.
- •Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
- •Subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area for the duration of the study, including the follow-up period, if requested.
- •Subject has read and signed a written informed consent form.
- •Subject is willing to comply with adjuvant topical regimen, as applicable.
- •Subject agrees not to undergo any other procedure(s) in the treatment area during the study.
排除标准
- •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
- •Use of Accutane within the previous 6 months
- •History of melanoma
- •Subject is pregnant or intending to become pregnant during the study period
- •Subject is lactating or has been lactating in the past 6 months
- •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.
- •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 unacceptable risk to the subject.
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: Up to 12 months
The safety of the treatment is determined by the incidence of device- or procedure-related serious adverse events.
Change in appearance in the treated area as determined by the Physician Global Assessment (PGA).
时间窗: up to 3 months
Investigator assessment using Physician Global Assessment (PGA); graded from "4" (very much improved") to "0" (worse).
次要结局
未报告次要终点