Status:
COMPLETED
Clinical Evaluation of Healthy Subjects Receiving Intradermal Saline Using the Microneedle Adapter (Model UAR-2S)
Lead Sponsor:
Microdermics Inc.
Conditions:
Intradermal Injection
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
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 si...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03415373
Start Date
November 1 2017
End Date
November 15 2017
Last Update
January 30 2018
Active Locations (1)
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1
inVentiv Health Clinique
Québec, Quebec, Canada, G1P 0A2