Human Repeat Insult Patch Test (HRIPT): Assessment of Skin Irritation and Sensitization of a Collagen-Based Material in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Allergic Contact Sensitization Response to SILURCLOUD Fibrous Collagen Matrix
研究概览
简要总结
This study evaluates skin irritation and sensitization following repeated application of a collagen-based material in healthy adult volunteers under controlled conditions. Skin responses will be assessed during study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 70 years
- •Male and female participants
- •Fitzpatrick Skin Types I and VI
- •Participants of any race
- •Participants of any ethnicity (Hispanic or Latino or Not Hispanic or Latino)
- •Generally healthy, without dermatological or systemic conditions that could interfere with study participation or evaluation of results, as determined by the investigator
- •Able to read and understand English and provide written informed consent
- •Able to comply with study procedures and complete all required visits
- •Willing to have test materials applied according to the study protocol
- •Has not participated in a similar clinical study within the previous 30 days
- •Agrees to avoid excessive sun exposure, sunbathing, or tanning during study participation
- •Female participants of childbearing potential willing to undergo pregnancy testing prior to participation
- •Agrees not to change current personal care products during study participation
排除标准
- •Use of medications that may interfere with study results (e.g., corticosteroids, antihistamines, immunosuppressive agents, or high-dose NSAIDs)
- •History of acute or chronic medical conditions that could interfere with study participation or increase risk (e.g., autoimmune disease, HIV infection)
- •Chronic skin conditions such as atopic dermatitis or eczema
- •Treatment for skin cancer within the previous 12 months
- •Abnormal or damaged skin at test sites that could interfere with evaluation (e.g., sunburn, tattoos, scars, active dermatologic conditions)
- •Diabetes requiring insulin therapy
- •Pregnant, planning pregnancy, or breastfeeding
- •Known hypersensitivity to personal care products, cosmetics, fragrances, or adhesives
- •Known fish allergy
- •Any condition that, in the opinion of the investigator, may compromise participant safety or study integrity
研究组 & 干预措施
Human Repeat Insult Patch Test Procedure
Participants will undergo repeated occlusive patch applications of a collagen-based material to assess skin irritation and sensitization in healthy adult volunteers.
干预措施: Collagen-Based Material (Device)
结局指标
主要结局
Allergic Contact Sensitization Response to SILURCLOUD Fibrous Collagen Matrix
时间窗: At the challenge phase (approximately 10-17 days after the last induction application)
Determination of allergic contact sensitization following challenge exposure to SILURCLOUD Fibrous Collagen Matrix in healthy subjects. Skin reactions at the challenge site will be graded using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4) at approximately 24 and 72 hours after patch removal.
Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale
时间窗: During the induction phase (approximately 3 consecutive weeks)
Dermal irritation response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4).
次要结局
- Dermal Safety Outcomes Stratified by Fitzpatrick Skin Type (I and VI)(Through completion of all skin assessments during the study (approximately 5-6 weeks))
- Allergic Contact Sensitization Response Using ICDRG Scale(Through completion of all skin assessments during the study (approximately 5-6 weeks))