NCT04510376已完成不适用
A Safety Study to Assess the Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Omeza, LLC
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Allergic Reaction
研究概览
简要总结
Single-center, monadic, one day study utilizing the skin prick method to assess the allergy potential of Omeza Collagen Matrix in Human Subjects
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 18 years of age and older as demonstrated by selfreported medical history, concurrent medication, and a brief dermal skin assessment of the test sites;
- •Fully informed of the risks of entering the study and willing to provide written informed consent and HIPAA authorization to disclose protected health information;
- •Subject has normal healthy skin on the either volar forearm.
排除标准
- •Subjects must be excluded if any of the following conditions exist:
- •Self-reported pregnant or nursing at the screening visit;
- •Clinically significant skin disease which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active cancer;
- •History of drug abuse or current drug user;
- •Treatment with antihistamine or steroid (any route) administered within the last 7 days;
- •History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax);
- •Persistent severe/ unstable asthma;
- •Subjects on beta blockers and/or ACE inhibitors;
- •Medical condition which in the opinion of the Investigator would compromise the safety of the subject or confound study results (Subjects with the following conditions: chronic renal failure, CVA, cancer, spinal cord injury, diabetic neuropathy, recent anaphylaxis, limbs affected by lymphoedema, paralysis, or neurogenic abnormalities;
- •Diabetic (type 1 or 2);
- •Subjects taking the following: Antidepressants such as doxepin, other tricyclics, Phenothiazines, and tetracyclics within the last two weeks;
- •Subjects taking OTC cold and flu remedies, "sinus" analgesics, antitussives, antiemetics, sedatives, relaxants, migraine prophylactics (cyproheptadine, pizotifen);
- •Prolonged use of topical corticosteroids;
- •Use of topical moisturizers on the volar forearms;
- •Dermographism "writing on the skin" - common localized hive reaction, characterized by the abrupt onset of welts and hives where the skin is exposed to pressure, scratching, itching, or stroking;
- •Investigator deems the subject an unsuitable candidate for this study.
结局指标
主要结局
Allergic Reaction
时间窗: 20 minutes
Response of at least 3-mm diameter (with equivalent erythema) more than negative control is required as proof of presence of cutaneous allergen specific IgE
次要结局
- Allergic Reaction(60 minutes)
研究者
研究点 (2)
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