The Effect of Microneedle Pretreatment on Topical Anesthesia

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Microneedle Roller; Device: Sham microneedle Roller

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Allergy to lidocaine
• Smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Microneedle Pretreatment; One ventral forearm is randomized to receive pretreatment with microneedle rollers that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 4 min, 10 min, and 30 min time points.	Device: Microneedle Roller; 200 micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller
Sham Comparator: Sham Microneedle Pretreatment; One ventral forearm is randomized to receive pretreatment with sham microneedle rollers (flat roller without any microneedles) that are 200 micrometers in length (Clinical Resolution Laboratories, Inc.). Then topical 4% lidocaine is applied and pain in assessed after a pain stimulus at the 2 min, 4 min, 10 min, and 30 min time points.	Device: Sham microneedle Roller; Flat roller without microneedles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale Pain	100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.	2 min
Visual Analog Scale Pain	100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.	5 min
Visual Analog Scale Pain	100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.	10 min
Visual Analog Scale Pain	100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.	30 min

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

General Publications

• Sivamani RK, Liepmann D, Maibach HI. Microneedles and transdermal applications. Expert Opin Drug Deliv. 2007 Jan;4(1):19-25. doi: 10.1517/17425247.4.1.19.
• Sivamani RK, Stoeber B, Wu GC, Zhai H, Liepmann D, Maibach H. Clinical microneedle injection of methyl nicotinate: stratum corneum penetration. Skin Res Technol. 2005 May;11(2):152-6. doi: 10.1111/j.1600-0846.2005.00107.x.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: October 31, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 252160