Human Repeat Insult Patch Test (HRIPT): Assessment of Primary and Cumulative Skin Irritation and Skin Sensitization of a Product, Under Controlled and Maximized Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Skin Sensitization Reaction Using Berger and Bowman Scale
研究概览
简要总结
The objectives of this study are to determine by repetitive epidermal contact, the primary or cumulative irritation and the allergic contact sensitization potential of the ColActive Plus Collagen Matrix Dressing, under maximized conditions, with controlled product quantity and application site.
详细描述
Approximately 75 healthy subjects satisfying all criteria listed below will be enrolled to complete the study with a minimum of 50 subjects. The test product will be applied on the 25-millimeter Hill Top Chamber®, which will be applied directly to the test site. The positive control will be applied to each subject for the first 48 hours only, and the negative control will be applied throughout the study along with the test product. Enough product will be used to cover the chamber. The procedure involves occlusive patching of the test product and control(s) for a minimum of 48 hours followed by an assessment. The procedure will be repeated until a series of 9 consecutive 48-hour exposures have been made over 3 consecutive weeks. This induction phase is followed by an approximate two-week rest period. The challenge phase consists of a challenge or test dose applied once to a previously unexposed test site. Clinical staff will remove the patches 48 hours post-application. Reactions will be scored 30 minutes post-removal, 24-hours post-removal, and 48-hours post-removal. Skin response at each application site will be evaluated according to the Berger and Bowman Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Sex: Male & Female
- •Fitzpatrick: I-V, minimum 10% of panel Fitzpatrick V.
- •Individuals who will be able to read, understand and give an informed consent relating to the study they are participating in.
- •Individuals who will be free of any dermatological or systemic disorder, which in the Investigator's opinion, could interfere with the study results.
- •Individuals who will be in general good health and who will complete a preliminary medical history form mandated by the testing facility.
- •Individuals who will be able to and agree to cooperate with the Investigator and clinical staff.
- •Individuals who will agree to have test products applied in accordance with the protocol and are able to complete the full course of the study.
- •Individuals who have not participated in a similar study in the past 30 days.
- •Individuals who agree to refrain from sun tanning/bathing and prolonged exposure to sunlight (outdoors).
- •Female volunteers who are willing to undergo a urine pregnancy test.
- •Individuals who agree to not change their current brand of personal care products such as soaps, body washes, laundry detergents, body sprays, body spritzes, etc. while participating on the study.
排除标准
- •Individuals who are currently taking any medications (topical or systemic) that may mask or interfere with the test results (specifically, corticosteroids, topical and/or systemic [except nasal steroids], non steroidal anti-inflammatory drugs [e.g. ibuprofen, Advil, Motrin, aspirin > 325mg/day], antihistamines, and topical/oral immunosuppressive medications). Subjects must refrain from using any topical/oral anti-inflammatory medications during the length of the study (6 weeks).
- •Individuals who have a history of any acute or chronic disease that might interfere with or increase the risk on study participation. (e.g., systemic lupus erythematosus, rheumatoid arthritis, HIV positive).
- •Individuals who are diagnosed with chronic skin allergies (atopic dermatitis/eczema) or recently treated skin cancer within the last 12 months.
- •Individuals who have damaged skin in close proximity to test sites (e.g., sunburn, uneven skin pigmentation, tattoos, scars, excessive hair, active acne papules or other disfigurations).
- •Individuals who control their diabetes using insulin.
- •Individuals with any history, which in the Investigator's opinion, indicates the potential for harm to the subject or places the validity of the study in jeopardy.
- •Female volunteers who indicate that they are pregnant or are planning to become pregnant or nursing.
- •Individuals with a known history of hypersensitivity to any cosmetics, personal care products, fragrances, and/or adhesives.
- •Employees of ALS.
- •Individuals with a known fish allergy.
研究组 & 干预措施
Collagen wound dressing with positive and negative controls
Application of test dressing, 0.5% sodium lauryl sulfate in distilled water, and distilled water on areas of the back or upper arm.
干预措施: ColActive Plus Collagen Matrix Dressing (Device)
结局指标
主要结局
Skin Sensitization Reaction Using Berger and Bowman Scale
时间窗: 48 hours post challenge and 24 hours and 48 hours post-challenge removal
Inflammatory response graded as 0 through 3: 0=no visible reaction; +=slight, confluent, or patchy erythema; 1=Mild erythema (pink); 2=moderate erythema (definite redness); 3=strong erythema (very intense redness) Definition of letter grades appended to a numerical grade: E = Edema - swelling, spongy feeling when palpated P = Papule - red, solid, pinpoint elevation V = Vesicle - small elevation containing fluid B = Bulla reaction - fluid-filled lesion (blister) S = Spreading - evidence of the reaction beyond the Webril® pad area W = Weeping - result of a vesicular or bulla reaction - serous exudate I = Induration - solid, elevated, hardened, thickened skin Superficial Effects g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish-brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring - grooves in the superficial layers of the skin
次要结局
未报告次要终点