NCT02548533

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

September 4, 2015

Last Update Submit

March 11, 2019

Conditions

Cicatrix

Outcome Measures

Primary Outcomes (1)

  • Pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) at each of both regions.

    < 1 minute after AFXL treatment

Study Arms (2)

Region 1

ACTIVE COMPARATOR

Standard topical anesthesia using eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) applied two hours before treatment.

Drug: EMLA cream

Region 2

EXPERIMENTAL

Anesthesia using articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) applied on ablative fractional laser (AFXL) pretreated skin 15 minutes prior to the treatment.

Device: AFXLDrug: AHES

Interventions

AFXLDEVICE

Pretreatment at 2.5 mJ/microbeam and 15% density.

Also known as: Fractional carbon dioxide laser, Ablative fractional laser, Fractional CO2 laser, UltraPulse®, DeepFx handpiece; Lumenis Inc.
Region 2
AHESDRUG

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

Also known as: Ultracain DS Forte, articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
Region 2
EMLA creamDRUG

Topical application 2 hours prior to the treatment.

Also known as: lidocaine 25 mg/g + prilocaine 25 mg/g cream
Region 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acne scars or traumatic scars scheduled for treatment with the fractional carbon dioxide laser
  • Age ≥18 years
  • Patient is willing and able to give written informed consent

You may not qualify if:

  • Known allergy to local anesthesia
  • Pregnancy or lactation
  • Incompetency to understand what the procedure involves
  • Current complaints of chronic pain or other alterations in pain sensation (e.g. due to diabetes mellitus or lepra)
  • Current treatment with systemic analgesics or other medication that can influence pain sensation
  • Total lesional area to be treated in one session \>600 cm2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Institute for Pigment disorders

Amsterdam, 1105AZ, Netherlands

Location

Related Publications (11)

  • Haedersdal M, Sakamoto FH, Farinelli WA, Doukas AG, Tam J, Anderson RR. Fractional CO(2) laser-assisted drug delivery. Lasers Surg Med. 2010 Feb;42(2):113-22. doi: 10.1002/lsm.20860.

    PMID: 20166154BACKGROUND

  • Haak CS, Farinelli WA, Tam J, Doukas AG, Anderson RR, Haedersdal M. Fractional laser-assisted delivery of methyl aminolevulinate: Impact of laser channel depth and incubation time. Lasers Surg Med. 2012 Dec;44(10):787-95. doi: 10.1002/lsm.22102. Epub 2012 Dec 4.

    PMID: 23212624BACKGROUND

  • Oni G, Rasko Y, Kenkel J. Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation. Aesthet Surg J. 2013 Aug 1;33(6):854-61. doi: 10.1177/1090820X13496248.

    PMID: 23908302BACKGROUND

  • Ong MW, Bashir SJ. Fractional laser resurfacing for acne scars: a review. Br J Dermatol. 2012 Jun;166(6):1160-9. doi: 10.1111/j.1365-2133.2012.10870.x. Epub 2012 May 8.

    PMID: 22296284BACKGROUND

  • Wolfe JW, Butterworth JF. Local anesthetic systemic toxicity: update on mechanisms and treatment. Curr Opin Anaesthesiol. 2011 Oct;24(5):561-6. doi: 10.1097/ACO.0b013e32834a9394.

    PMID: 21841477BACKGROUND

  • Koh JL, Harrison D, Swanson V, Norvell DC, Coomber DC. A comparison of laser-assisted drug delivery at two output energies for enhancing the delivery of topically applied LMX-4 cream prior to venipuncture. Anesth Analg. 2007 Apr;104(4):847-9. doi: 10.1213/01.ane.0000257925.36641.9e.

    PMID: 17377092BACKGROUND

  • Baron ED, Harris L, Redpath WS, Shapiro H, Hetzel F, Morley G, Bar-Or D, Stevens SR. Laser-assisted penetration of topical anesthetic in adults. Arch Dermatol. 2003 Oct;139(10):1288-90. doi: 10.1001/archderm.139.10.1288.

    PMID: 14568832BACKGROUND

  • Shapiro H, Harris L, Hetzel FW, Bar-Or D. Laser assisted delivery of topical anesthesia for intramuscular needle insertion in adults. Lasers Surg Med. 2002;31(4):252-6. doi: 10.1002/lsm.10101.

    PMID: 12355570BACKGROUND

  • Togsverd-Bo K, Haak CS, Thaysen-Petersen D, Wulf HC, Anderson RR, Haedersdal M. Intensified photodynamic therapy of actinic keratoses with fractional CO2 laser: a randomized clinical trial. Br J Dermatol. 2012 Jun;166(6):1262-9. doi: 10.1111/j.1365-2133.2012.10893.x.

    PMID: 22348388BACKGROUND

  • Hantash BM, Bedi VP, Chan KF, Zachary CB. Ex vivo histological characterization of a novel ablative fractional resurfacing device. Lasers Surg Med. 2007 Feb;39(2):87-95. doi: 10.1002/lsm.20405.

    PMID: 17115384BACKGROUND

  • Haak CS, Bhayana B, Farinelli WA, Anderson RR, Haedersdal M. The impact of treatment density and molecular weight for fractional laser-assisted drug delivery. J Control Release. 2012 Nov 10;163(3):335-41. doi: 10.1016/j.jconrel.2012.09.008. Epub 2012 Sep 21.

    PMID: 23000695BACKGROUND

MeSH Terms

Conditions

Cicatrix

Interventions

CarticaineEpinephrineLidocaine, Prilocaine Drug CombinationLidocainePrilocaine

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAcetanilidesAnilidesAmidesAniline CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Albert Wolkerstorfer, MD, PhD

    Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam

    PRINCIPAL INVESTIGATOR

  • Menno A. De Rie, MD, PhD

    Department of Dermatology, Academic Medical Center, University of Amsterdam

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 14, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

NL(1)