The Effect of Microneedle Pretreatment on Topical Anesthesia

NCT02596750 | Completed Results

• 1 other identifier: 252160
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Microneedle Pretreatment

ACTIVE COMPARATOR

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

Sham Microneedle Pretreatment

SHAM COMPARATOR

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

Interventions

Microneedle Roller DEVICE

200 micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller

Microneedle Pretreatment

Sham microneedle Roller DEVICE

Flat roller without microneedles

Sham Microneedle Pretreatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers

You may not qualify if:

• Allergy to lidocaine
• Smokers

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95816, United States

Location

Related Publications (2)

• 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.

  PMID: 15807814 BACKGROUND

• 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.

  PMID: 17184159 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Raja Sivamani MD
• Organization: UC Davis Department of Dermatology

dermstudies@ucdavis.edu

916-703-5145

Study Officials

• Raja K Sivamani, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject will serve as his or her own control. The right forearm and the left forearm will be randomized through a binary randomization to determine whether the right arm will receive microneedle treatment or sham microneedle treatment (roller with no microneedles). This randomization is developed through code in Excel that will result in binary result of either the value 0 or 1 for each subject. For those subjects assigned a binary code of 0, the right forearm will receive microneedle treatment and the left forearm will receive sham microneedle treatment. For those subjects assigned a binary code of 1, the left forearm will receive microneedle treatment and the right forearm will receive sham microneedle treatment.

Study Record Dates

• First Submitted: October 31, 2015
• First Posted: November 4, 2015
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 27, 2018
• Results First Posted: November 27, 2018

Record last verified: 2018-11

Locations

US (1)