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Fractional Laser Assisted Delivery of Anesthetics

NCT02246179 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-11-10

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy of fractional CO2 laser assisted delivery of topically applied anesthetics (articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml solution and EMLA cream) regarding to anesthesia of the skin.

Conditions

  • Local Anesthesia of the Skin.

Interventions

DEVICE

AFXL

Pretreatment at 2.5 mJ/microbeam and 5% density Pain stimulus at 35 mJ/microbeam and 5% density

DRUG

AHES

Topical application at test region 1 and 3 under occlusion for 10 minutes

DRUG

EMLA cream

Topical application at test region 2 and 4 under occlusion for 10 minutes

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Netherlands Institute for Pigment Disorders

    lead OTHER

Principal Investigators

  • Albert Wolkerstorfer, MD, PhD · Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam

  • Menno A. De Rie, MD, PhD · Department of Dermatology, Academic Medical Center, University of Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246179 on ClinicalTrials.gov