Site Selection for Intracutaneous Saline Delivery

NCT ID: NCT01767324

Last Updated: 2017-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Test ability to inject saline into various sites on body.

Conditions

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Intracutaneous Drug Delivery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Injection to deltoid

Deliver saline from FLUGEN 101.2 microneedle-based delivery device.

Group Type EXPERIMENTAL

Injection to deltoid

Intervention Type DEVICE

Deliver 0.5 milliliters of saline intradermally

Injection to forearm

Deliver saline from FLUGEN 101.2 microneedle-based delivery device.

Group Type EXPERIMENTAL

Injection to forearm

Intervention Type DEVICE

Deliver 0.5 milliliters of saline intradermally

Injection to thigh

Deliver saline from FLUGEN 101.2 microneedle-based delivery device.

Group Type EXPERIMENTAL

Injection to thigh

Intervention Type DEVICE

Deliver 0.5 milliliters of saline intradermally

Interventions

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Injection to deltoid

Deliver 0.5 milliliters of saline intradermally

Intervention Type DEVICE

Injection to forearm

Deliver 0.5 milliliters of saline intradermally

Intervention Type DEVICE

Injection to thigh

Deliver 0.5 milliliters of saline intradermally

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Accelovance

INDUSTRY

Sponsor Role collaborator

FluGen Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renee Herber

Role: STUDY_DIRECTOR

FluGen Inc

Murray A Kimmel, DO

Role: PRINCIPAL_INVESTIGATOR

Accelovance

Locations

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Accelovance Inc

Melbourne, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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FGN-NSR-2012-001

Identifier Type: -

Identifier Source: org_study_id

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