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Fractional Laser Assisted Topical Anesthesia

NCT02548533 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-03-13

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) prior to ablative fractional laser treatment of acne scars and traumatic scars.

Conditions

  • Cicatrix

Interventions

DEVICE

AFXL

Pretreatment at 2.5 mJ/microbeam and 15% density.

DRUG

AHES

Topical application on AFXL pretreated skin 15 minutes prior to the treatment.

DRUG

EMLA cream

Topical application 2 hours prior to the treatment.

Sponsors & Collaborators

  • 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
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-01-31
Completion
2016-01-31

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 NCT02548533 on ClinicalTrials.gov