FindTrial
Sign In

Site Selection for Intracutaneous Saline Delivery

Exploratory Evaluation of Injection Sites in Healthy Subjects Receiving Saline Delivered by a Non-Significant Risk Investigational Device Utilizing a Micro-Needle Array

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01767324
Enrollment
12
Registered
2013-01-14
Start date
2012-12-31
Completion date
2012-12-31
Last updated
2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracutaneous Drug Delivery

Keywords

microneedle-based array, hollow microneedle, intracutaneous, drug delivery, vaccine delivery

Brief summary

The goal of this exploratory study is to select the optimal body site for intracutaneous delivery of 0.5 milliliters of saline from the FLUGEN 101.2 microneedle-based device.

Detailed description

Test ability to inject saline into various sites on body.

Interventions

DEVICEInjection to deltoid

Deliver 0.5 milliliters of saline intradermally

DEVICEInjection to forearm

Deliver 0.5 milliliters of saline intradermally

DEVICEInjection to thigh

Deliver 0.5 milliliters of saline intradermally

Sponsors

Accelovance
CollaboratorINDUSTRY
FluGen Inc
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Able to read and/or understand and sign the Informed Consent Form

Exclusion criteria

* Medical history of acute or chronic skin disease * Active skin allergy or acute skin infection, 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.

Design outcomes

Primary

MeasureTime frameDescription
The primary objective is to evaluate the safety and tolerability/reactogenicity of saline delivery from the FLUGEN 101.2 microneedle-based device as evidenced by change of dose site appearance over time.30 minutes, 24 hours, 1 weekObserve injection sites for change of appearance post-dose including wheal formation or resolution.

Secondary

MeasureTime frameDescription
A secondary objective of this study is to evaluate the mechanical elimination of fluid from the device.3 minutesEvaluate ability of device to dispense targeted dose volume.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026