Skin Prick Test of KeraStat® Cream
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Reaction to Test Article
研究概览
简要总结
To evaluate the potential for a humoral reaction to KeraStat Cream compared to a predicate device using the skin prick test.
详细描述
Study Overview:
Study Periods:
The length of study participation for a subject is about 2-3 days depending on availability for the final site check. There are two skin prick site checks during the course of Day 1 with a final follow up between Days 2 and 3.
Study Evaluations:
Initial screening (Screening Visit; Visit 1) will be performed on the day of the Skin Prick Test (SPT) administration and will include obtaining demographic information, brief medical history, and abbreviated physical exam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, age 18-65
- •Able to understand the informed consent and provide written informed consent
- •Healthy, unmarked skin at the test area
- •Agreement to avoid consumption of antihistamines until completion of third test reading (Visit 2)
排除标准
- •Women who are pregnant, lactating/nursing or plan to become pregnant
- •Presence of skin disease, such as widespread urticaria or eczema
- •Diagnosis of infectious disease
- •Receiving corticosteroids, immunosuppressive agents, radiation or chemotherapy, topical growth factors, anxiolytics, imipramine, phenothiazine, dopamine, phenergen, clonidine, montelukast, immunotherapy, UV light therapy, H-2 antagonist, cyclosporine or any other medication the investigator feels will affect the test within the last month
- •Medical history of hypotension, severe hypertension, vasomotor instability, asthma, autoimmune disease, severe cardiac, pulmonary or renal disease
- •Tattoo in the intrascapular test area
- •History of surgical procedure/skin graft in the intrascapular test area
- •Employee or relative of employee of KeraNetics
- •Consumption of an anti-histamine within 7 days of the screening visit
- •History of hypersensitivity to histamine products
- •Any condition the investigator determines will compromise subject safety or prevent the subject from completing the study
- •Participated in an investigational study within 30 days of the screening visit
研究组 & 干预措施
KeraStat® Cream
KeraStat® Cream is a non-sterile, non-implantable wound dressing intended to provide a moist environment in the management of a variety of partial thickness dermal wounds.
干预措施: KeraStat® Cream (Device)
KeraStat® Gel
KeraStat® Gel is a sterile, non-implantable water-based gelatinous (hydrogel) wound dressing intended to act as a protective covering in the management of a variety of partial thickness dermal wounds.
干预措施: KeraStat Gel (Device)
Biafine
Wound dressing for management of partial and full thickness wounds.
干预措施: Biafine (Device)
Histamine
Histamine is provided as a solution of histamine base (6.0 mg/mL).
干预措施: Histamine (Drug)
Saline
Saline (sterile) is provided as a 0.9% NaCl solution.
干预措施: Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Reaction to Test Article
时间窗: assessed at 15 min, 6 hours, 24-48 hours; 15 min reported
Wheal measurement in millimeters (mm)
次要结局
未报告次要终点