Site Selection for Intracutaneous Saline Delivery

FluGen

Status: Completed

Conditions: Intracutaneous Drug Delivery

Treatments: Device: Injection to forearm; Device: Injection to thigh; Device: Injection to deltoid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01767324

FGN-NSR-2012-001

Details and patient eligibility

About

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.

Full description

Test ability to inject saline into various sites on body.

Enrollment: 12 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Injection to deltoid

Experimental group

Description:

Deliver saline from FLUGEN 101.2 microneedle-based delivery device.

Treatment:

Device: Injection to deltoid

Injection to forearm

Experimental group

Description:

Deliver saline from FLUGEN 101.2 microneedle-based delivery device.

Treatment:

Device: Injection to forearm

Injection to thigh

Experimental group

Description:

Deliver saline from FLUGEN 101.2 microneedle-based delivery device.

Treatment:

Device: Injection to thigh