Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System

Completed

Conditions studied: Functionality and Performance of Device

In brief

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.

Key facts

Study ID

NCT01494571

Run by

University of Colorado, Denver

People needed

101

Starts

2011-12-01

Expected to finish

2012-09-01

Last updated by the study team

2013-03-07

Who can join

Age: 0 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.