Intracutaneous Delivery of Varied Dose Volumes of Saline
Exploratory Evaluation of Healthy Subjects Receiving Varied Dose Volumes of Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array
1 other identifier
interventional
24
1 country
1
Brief Summary
This study will evaluate intracutaneous delivery of 0.1, 0.25 and 0.5 milliliter volumes of saline from the FLUGEN 101.2 investigational microneedle-based device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 14, 2013
CompletedAugust 2, 2017
July 1, 2017
Same day
January 9, 2013
July 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective is to evaluate the safety and tolerability/reactogenicity of various saline volumes delivered from the FLUGEN 101.2 microneedle-based device as evidenced by change of dose site appearance over time.
Observe injection sites for change of appearance post-dose including initial wheal formation and subsequent resolution.
30 minutes, 24 hours, ~ 1 week
Secondary Outcomes (1)
A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.
3 minutes
Study Arms (3)
injection of 0.1 mL saline
EXPERIMENTALdeliver from FluGen 101.2 device
injection of 0.25 mL saline
EXPERIMENTALdeliver from FluGen 101.2 device
Injection of 0.5 mL saline
EXPERIMENTALdeliver from FluGen 101.2 device
Interventions
Eligibility Criteria
You may qualify if:
- Able to read and/or understand and sign the Informed Consent form
You may not qualify if:
- Medical history of acute or chronic skin disease
- Active skin allergy or acute skin infection, presence of tattoo(s), scars, sunburn or skin abnormalities at any prospective injection site
- Hirsute at any prospective injection site
- Diabetes
- High levels of anxiety or depression or history of psychosis
- Abuse of alcohol or use of other drugs of abuse including tobacco
- Pregnant or breastfeeding women
- Any medical condition that may interfere with study protocol adherence including completion of study activities
- Foreseeable inability to complete the study as scheduled.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FluGen Inclead
- Accelovancecollaborator
Study Sites (1)
Accelovance Inc
Melbourne, Florida, 32935, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Renee Herber
FluGen Inc
- PRINCIPAL INVESTIGATOR
Murray A Kimmel, DO
Accelovance
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2013
First Posted
January 14, 2013
Study Start
December 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 2, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share