NCT02596750

The Effect of Microneedle Pretreatment on Topical Anesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the role of microneedle pretreatment in the speed at which anesthesia develops after application of topical 4% lidocaine.

Detailed description

This study evaluates whether the time to anesthesia with topical 4% lidocaine can be accelerated with the use of microneedle pretreatment. The study will evaluate the anesthesia as a randomized split-body study where each subject serves as their own control. The study will be performed on the volar forearm. Prior to application of the topical 4% lidocaine, one arm will be exposed to a microneedle pretreatment on a microneedle roller and the other arm will be exposed to sham microneedle treatment that will consist of a flat roller with no microneedles. Then pain will be assessed with the use of a spring loaded needle lancet that will be applied at 2 min, 5 min, 10 min, and 30 minutes after treatment.

Conditions

• Pain

Interventions

Type	Name	Description
DEVICE	Microneedle Roller	200 micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller
DEVICE	Sham microneedle Roller	Flat roller without microneedles

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-11-04
• Last updated: 2018-11-27
• Results posted: 2018-11-27

Locations

1 site across 1 country: United States