Clinical Evaluation of Healthy Subjects Receiving Intradermal Saline Using the Microneedle Adapter (Model UAR-2S)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluate the performance of the Microneedle Adapter in the deltoid
研究概览
简要总结
Microdermics Inc. is a British Columbia-based Canadian incorporation primarily focusing on microneedle-based painless and effective drug delivery systems.The Microneedle Adapter (model UAR-2S) is a single-use disposable medical device intended to provide a mechanism for intradermal bolus fluid delivery when used with a standard syringe with a Luer-lock tip connection. The Microneedle Adapter consists of a single-use gold-coated metallic microneedle integrated within the microneedle adapter with fluidic connections to a standard Luer syringe mount. The primary function of the Microneedle Adapter is to guide the microneedle into the skin in a controlled manner for successful insertion passing the stratum corneum layer. The fluid loaded onto the syringe can then be injected precisely intradermally into the skin.The primary objective of this study is to evaluate the performance of the Microneedle Adapter in healthy subjects in 3 different injection sites. Pain perception of the Microneedle Adapter will be a key secondary outcome, compared with the control device.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female, 19-65 years old inclusive, non-smoker (no use of tobacco products within 3 months prior to screening)
- •Able to understand the informed consent form and willing to participate in study
- •Intact skin at the sites of injection
- •Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after the last study drug administration:
- •intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration;
- •male condom with intravaginally applied spermicide starting at least 14 days prior to study drug administration;
- •hormonal contraceptives starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study;
- •sterile male partner (vasectomized since at least 6 months).
排除标准
- •Fear or anxiety of needles, or needle phobia
- •Known sensitivity to nickel
- •Presence of a skin condition at the treatment are that may affect the configuration or thickness of the dermal layer (e.g. plaque psoriasis)
- •Permanent makeup/tattoo/body piercing or other markings in the treatment area that would impact the ability to assess adverse events (e.g. erythema) following ID administration
- •Use of medication that may affect the mechanical properties of the skin in the treatment area (e.g. prolonged use of a steroids, analgesics or other non-steroidal inflammatory drugs)
- •Any implantable metal device in the treatment area
- •Any surgical procedure, or other invasive or non-invasive method of skin therapy hair removal or filers or Botox in the treatment area, performed in the past 1 months (in the treatment area).
- •Any form of suspicious lesion on the treatment area
- •Hypertrophic scarring, keloids, abnormal wound healing, as well as very dry and fragile skin.
- •Any infection/abscess/pain in treatment area
- •Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash
- •History of skin allergy or hypersensitivity
- •History of easy bruising
- •Actively taking antibiotics for an infection
- •Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- •Any other condition that would exclude the subject study participation according to the Investigator's clinical judgment
- •Concurrent participation in any other clinical study
- •Unable to understand the informed consent
- •Unable to verbally communicate in English or French
- •If female, pregnant, suspected or planning to become pregnant or breast-feeding
结局指标
主要结局
Evaluate the performance of the Microneedle Adapter in the deltoid
时间窗: 1 day
Consistency of injected fluid volume by gravimetric technique
Evaluate the performance of the Microneedle Adapter in the thigh
时间窗: 1 day
Consistency of injected fluid volume by gravimetric technique
Evaluate the performance of the Microneedle Adapter in the inner forearm
时间窗: 1 day
Consistency of injected fluid volume by gravimetric technique
次要结局
- Collection and evaluation of adverse events [safety and tolerability](2 weeks)
- Assessment of contact dermatitis using Draize Scale [safety and tolerability](2 weeks)
- Assess end-user satisfaction in using the Microneedle Adapter and obtain feedback on the device's design(2 weeks)
- Evaluate pain perception of the Microneedle Adapter vs. the control device(1 day (post needle injection and post fluid injection))