Intradermal Injection Clinical Trial
Official title:
Clinical Evaluation of Healthy Subjects Receiving Intradermal Saline Using the Microneedle Adapter (Model UAR-2S)
| Verified date | January 2018 |
| Source | Microdermics Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | November 15, 2017 |
| Est. primary completion date | November 15, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 1. Healthy male or female, 19-65 years old inclusive, non-smoker (no use of tobacco products within 3 months prior to screening) 2. Able to understand the informed consent form and willing to participate in study 3. Intact skin at the sites of injection 4. 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: 1. intra-uterine contraceptive device placed at least 4 weeks prior to study drug administration; 2. male condom with intravaginally applied spermicide starting at least 14 days prior to study drug administration; 3. hormonal contraceptives starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study; 4. sterile male partner (vasectomized since at least 6 months). Exclusion Criteria: 1. Fear or anxiety of needles, or needle phobia 2. Known sensitivity to nickel 3. Presence of a skin condition at the treatment are that may affect the configuration or thickness of the dermal layer (e.g. plaque psoriasis) 4. 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 5. 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) 6. Any implantable metal device in the treatment area 7. 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). 8. Any form of suspicious lesion on the treatment area 9. Hypertrophic scarring, keloids, abnormal wound healing, as well as very dry and fragile skin. 10. Any infection/abscess/pain in treatment area 11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash 12. History of skin allergy or hypersensitivity 13. History of easy bruising 14. Actively taking antibiotics for an infection 15. 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. 16. Any other condition that would exclude the subject study participation according to the Investigator's clinical judgment 17. Concurrent participation in any other clinical study 18. Unable to understand the informed consent 19. Unable to verbally communicate in English or French 20. If female, pregnant, suspected or planning to become pregnant or breast-feeding |
| Country | Name | City | State |
|---|---|---|---|
| Canada | inVentiv Health Clinique | Québec City | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Microdermics Inc. |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the performance of the Microneedle Adapter in the inner forearm | Consistency of injected fluid volume by gravimetric technique | 1 day | |
| Primary | Evaluate the performance of the Microneedle Adapter in the deltoid | Consistency of injected fluid volume by gravimetric technique | 1 day | |
| Primary | Evaluate the performance of the Microneedle Adapter in the thigh | Consistency of injected fluid volume by gravimetric technique | 1 day | |
| Secondary | Evaluate pain perception of the Microneedle Adapter vs. the control device | Assessment of pain intensity using Numeric Rating Scale (NRS), a verbal 0-10 point scale where 0 means no pain and 10 means worst possible pain | 1 day (post needle injection and post fluid injection) | |
| Secondary | Collection and evaluation of adverse events [safety and tolerability] | Events will be reported by severity and causality | 2 weeks | |
| Secondary | Assessment of contact dermatitis using Draize Scale [safety and tolerability] | Draize scale has 4 components (Hemorrhage/petechiae, Erythema, Edema, Pruritus) with scores 0 up to 5, where 5 indicates worst event | 2 weeks | |
| Secondary | Assess end-user satisfaction in using the Microneedle Adapter and obtain feedback on the device's design | Assessment of end-user usability using the modified System Usability Scale (mSUS), a 10-question scale producing a normalized score 0 to 100, where 0 indicates high user dissatisfaction and 100 indicates high user satisfaction | 2 weeks |