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Fractional Laser Assisted Delivery of Anesthetics III

NCT02938286 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-03-29

No results posted yet for this study

Summary

The purpose of this study is to compare the effect of pretreatment with two different ablative laser modalities, a CO2 laser and an Er:YAG laser, and to assess the role of laser density in fractional laser assisted topical anesthesia.

Conditions

  • Local Anesthesia of the Skin

Interventions

DEVICE

Fractional CO2 laser, 2.5 mJ, 5% density

Pretreatment at 2.5 mJ/microbeam and 5% density. Pain stimulus at 50 mJ/microbeam and 5% density

DEVICE

Fractional CO2 laser, 2.5 mJ, 15% density

Pretreatment at 2.5 mJ/microbeam and 15% density. Pain stimulus at 50 mJ/microbeam and 5% density

DEVICE

Fractional Er:YAG laser, 9 mJ, 5% density

Pretreatment at 9 mJ and 5% density.

DEVICE

Fractional Er:YAG laser, 9 mJ, 15% density

Pretreatment at 9 mJ and 15% density.

DEVICE

Fractional CO2 laser, 50 mJ, 5% density

Pain stimulus at 50 mJ/microbeam and 5% density

DRUG

AHES

Topical application at test region I-IV under occlusion for 15 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
2016-03-31
Primary Completion
2016-08-31
Completion
2016-08-31

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 NCT02938286 on ClinicalTrials.gov