Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Functionality and Performance of Device

Study type: Observational

Funder types: Other

Identifiers

NCT01494571

11-1362

Details and patient eligibility

About

The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery.

Full description

Up to 400 children, ages 2 months through 14 years

1. To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings.
2. To document completeness of injections; completeness is defined as <10% of 0.1 ml volume remaining on the skin surface immediately after injection. Measurement of the bleb size following injection will recorded in millimeters.
3. To ensure device is well received by subjects. Subject's response to the injection will be noted by the subject and/or family members after the procedure for up to 48 hours.

Enrollment: 101 patients

Sex: All

Ages: 2 months to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants and children between ages 2 months and 14 years
• Outpatient, expected to go home day of surgery
• Written consent and assent when appropriate
• Willing to complete and return pain diary (postcard) after 48 hours

Exclusion criteria

• Presently have skin rash at the intended injection site
• Have a history of use of any topical or systemic medications at the intended injection site that could have potentially altered the normal physical properties of the skin (i.e. atrophy from chronic steroid use, thinning of the skin from topical or systemic retinoids).
• Have a permanent physical change in the skin at the intended injection site, such as burns, scars or prior radiation therapy.
• Skin disorders that may predispose them to develop skin lesions at sites of trauma.
• Present use of any blood thinning medications.
• In the 10-11 year old cohort, none of the participants can have started puberty.

Trial design

101 participants in 7 patient groups

90 pediatric, 7 to 14 year old subjects

30 pediatric, 5 to 6 year old subjects

30 pediatric, 3 to 4 year old subjects

30 pediatric, 1 to 2 year old subjects

30 pediatric, 6 to 12 month old subjects

30 pediatric, 4 to 6 month old subjects

30 pediatric, 2 to 4 month old subjects