Trial Outcomes & Findings for Performance and Safety Evaluation of an Intradermal Delivery Device (NCT NCT01359111)

Results Overview

The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

1 day

Results posted on

2012-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Intradermal Adapter Saline injection with intradermal adapter
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Performance and Safety Evaluation of an Intradermal Delivery Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intradermal Adapter n=20 Participants Saline injection with intradermal adapter
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	35.4 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.

Outcome measures

Outcome measures
Measure	Intradermal Adapter n=40 injections Saline injection with intradermal adapter	Bevel Down Saline injection with intradermal adapter used with needle bevel oriented down relative to the surface of the skin
Proportion of Injections Delivered to the Intradermal Layer of the Skin	1 percentage of injections	—

SECONDARY outcome

Timeframe: 2 days

The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.

Outcome measures

Outcome measures
Measure	Intradermal Adapter n=20 Participants Saline injection with intradermal adapter	Bevel Down Saline injection with intradermal adapter used with needle bevel oriented down relative to the surface of the skin
Proportion of Participants With Safety Events	0.25 percentage of participants	—

SECONDARY outcome

Timeframe: 1 day

The proportion of saline injections administered with the ID Adapter with needle bevel oriented up and needle bevel oriented down resulting in delivery to the intradermal layer of the skin. This will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.

Outcome measures

Outcome measures
Measure	Intradermal Adapter n=20 injections Saline injection with intradermal adapter	Bevel Down n=20 injections Saline injection with intradermal adapter used with needle bevel oriented down relative to the surface of the skin
Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.	1 percentage of injections	1 percentage of injections

Adverse Events

Intradermal Adapter

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intradermal Adapter n=20 participants at risk Saline injection with intradermal adapter
Skin and subcutaneous tissue disorders Abrasion	25.0% 5/20 • Number of events 5 • 2 days

Additional Information

Courtney Jarrahian

PATH

Phone: 206-285-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place