A 6-Week, Randomized, Evaluator-Blinded, In Vivo Within Subject Repeat Test to Evaluate the Irritation and Sensitization Potential of Omeza Collagen Matrix in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Omeza, LLC
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
研究概览
简要总结
The primary objective of this study was to assess the sensitization potential of Omeza Collagen Matrix compared to that of a negative control based on a Modified Human Repeat Insult Patch Test.
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
- Basic Science
- 盲法
- None
盲法说明
The trained skin evaluator and Investigator was blinded to the identity of the test materials. Test/control sites were randomized within participants.
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
- •Good general health, as assessed by medical history and brief dermal skin examination of the application site (back);
- •Was fully informed of the risks of entering the study and was willing to provide written consent to enter the study;
- •Was willing to follow study rules, which included: no sun exposure (for example; no swimming, sunbathing, or tanning beds), avoided activities that would cause excessive sweating, abstained from use of lotions, creams, or oils on the back area;
- •Was willing to not change current brand of personal care products such as soaps, body washes, laundry detergents, body sprays, body spritzes, etc. while participating on the study;
- •Was willing and able to practice an acceptable measure of contraception (i.e. birth control medication for at least 3 months prior, condom with spermicide or birth control injections,) during the study, if female of childbearing potential. To be considered female of non-childbearing potential, subject must have had a hysterectomy, tubal ligation, or had been post-menopausal for at least 1 year.
排除标准
- •Clinically significant skin disease which contraindicated participation, including psoriasis, eczema, atopic dermatitis, and active cancer;
- •Asthma that required medication;
- •Insulin-dependent diabetes;
- •Known immunological disorders such as HIV positive, AIDS and systemic lupus
- •erythematosus;
- •Treatment for any type of cancer within the last six months;
- •Routine use (as defined by using more than 3 days in a week) of any anti-inflammatory drug (e.g., aspirin, ibuprofen, corticosteroids; 81 mg aspirin is acceptable), immunosuppressive drugs, antihistamine medication (steroid nose drops and/or eye drops are acceptable) or over-the-counter pain medication that was ingested in quantities exceeding label instructions;
- •Use of topical drugs at patch site;
- •Pregnancy, lactation, or planning a pregnancy (confirmed by a urine pregnancy test administered to females of childbearing potential);
- •Medical condition which, in the Investigator's judgement, made the subject
- •ineligible or placed the subject at undue risk;
- •Participation in any patch test for irritation or sensitization within the last four weeks;
- •Dermatological aberrations in or around test sites which included sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or any other disfiguration of the test site;
- •Confirmed allergy to adhesives, bandages, or ingredients in OmezaTM Collagen Matrix;
- •History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax).
研究组 & 干预措施
Test Article (Omeza Collagen Matrix)
Repetitive and continuous patch applications of the test article to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours.
Each subject will receive both the test article and negative control at the same time.
干预措施: Test Article (Device)
Negative Control (0.9% aqueous sodium chloride)
Repetitive and continuous patch applications of the negative control to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours.
Each subject will receive both the test article and negative control at the same time.
干预措施: Negative Control (Other)
结局指标
主要结局
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
时间窗: 24, 48, 72, and 96 Hours
Erythema is evaluated during the challenge phase based on a numeric scale from 0 - 3 (0: No visible reaction, +: Slight/patchy, 1: Mild, 2: Moderate, 3: Strong). A score of 1, 2, or 3 indicates dermal sensitization.
次要结局
- Adverse Events Deemed Related to the Test Product or the Study(6 weeks)