Skin Sensitisation Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Induction Phase
研究概览
简要总结
Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical additives at a level on the gloves that may induce type IV allergy to the unsensitized general user population when using polychloroprene based surgical gloves
详细描述
- To evaluate whether residual chemical additives at a level that may induce Type IV allergy in the unsensitized general user population are present in a finished Polychloroprene Rubber Containing Medical Device, Powder Free Polychloroprene Surgical Gloves, Sterile. (CR-SG-140-AF-WH)
- To meet requirements for claim: This product demonstrated reduced potential for sensitizing users to chemical additives as described in Guidance for Industry and FDA Staff- Medical Glove Guidance Manual. Supporting Test Data: A negative skin sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human subjects.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The test subjects are normal volunteers who have documented informed consent and have not participated in other voluntary testing for at least 30 days.
- •Age of the test subjects ranged from 18 to 65 years.
- •Efforts are made to provide racial and gender diversity of the test subjects that reasonably reflects the general user population in the US
排除标准
- •The test subjects with any visible skin disease that might be confused with skin reactions caused by the test material.
- •The test subjects with any indication of existing Type I allergy to natural rubber proteins.
- •The test subjects who have used corticosteroids, either systemically or topically on the potential test site, two weeks before testing.
- •Test subjects who have received endogenous or exogenous immunosuppressive treatments (or prolonged sun exposure).
- •All subjects who are pregnant or become pregnant during the study.
- •All lactating women,
研究组 & 干预措施
Device and Control
Device:
Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, Tested for use with Chemotherapy Drugs.
Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
Positive Control:
0.4% Sodium Lauryl Sulfate (SLS) Dose. 0.2 ml
干预措施: Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs. (Device)
结局指标
主要结局
Induction Phase
时间窗: 24 days
Irritation scored by Erythemal Scoring Scale, Basic Score - Description: 0 - No visible reaction. 0.5 - Doubtful or Negligible Erythema Reaction. 1.0 - Mild or just perceptible macular erythema reaction in a speckled / follicular, patchy or confluent pattern (slight pinking). 2.0 - Moderate erythema reaction in a confluent pattern (definite redness). 3.0 - Strong or brisk erythema reaction that may spread beyond the test site.
Challenge Phase
时间窗: 48 hours
Irritation scored by Erythemal Scoring Scale, Basic Score - Description : 0 - No visible reaction. 0.5 - Doubtful or Negligible Erythema Reaction. 1.0 - Mild or just perceptible macular erythema reaction in a speckled / follicular, patchy or confluent pattern (slight pinking). 2.0 - Moderate erythema reaction in a confluent pattern (definite redness). 3.0 - Strong or brisk erythema reaction that may spread beyond the test site.
次要结局
未报告次要终点