Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.
试验速览
- 阶段
- 1 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Existing methods of diagnosing and treating skin lesions are either surgical, which enables an histological diagnosis or destructive (electrodesiccation, liquid nitrogen, laser, caustics) with no possibility of obtaining histology. The ingredients of current formulations for in-vivo skin fixation (Mohs, Solcoderm) are unstable, inconvenient for application and painful - therefore their use was abandoned. The investigators will examine the safety of stable formalin-free formulations for in-vivo fixation of human skin lesions .These formulations were safe and had a rapid onset of fixation effect in in-vivo animal studies.
详细描述
The formulations are comprised of standard non-toxic laboratory chemicals that are used in various dermatological preparations.
Transition metal salts - Zinc chloride, zinc bromide, zinc iodide,zinc nitrate, zinc sulphate. copper chloride ,copper bromide, copper iodide, copper nitrate, copper sulphate.
Keratolytics - salicylic acid , lactic acid, nitric acid, pyruvic acid,oxalic acid, trichloro acetic acid, phenol, resorcinol,urea .
The solvents and penetration enhancers of the ingredients - Water, ethanol, dimethyl sulfoxide, propylene glycol, glycerol.
Patients with skin lesions that after clinical diagnosis are usually treated by dermatologists with destructive modalities without an histological evaluation will be included in the study. The clinical diagnoses include viral warts, seborrheic warts, skin tags, solar keratoses, fibromata and hemangiomata.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with skin lesions that are not treated with histology
排除标准
- •Seriously ill patients
研究组 & 干预措施
Skin lesions
Individuals with skin lesions whose lesions are not sent for histology by dermatologists
干预措施: Formulations for in-vivo fixation (Device)
结局指标
主要结局
Safety
时间窗: One year
Infiltration of formulations into skin lesions.
Safety of formulations
时间窗: One year
Infiltration of the formulations into skin lesions with resultant in-vivo fixation and the achievement of histological result. Possible local pain, infection and scarring will be evaluated.
次要结局
未报告次要终点