Fractional Laser Assisted Delivery of Anesthetics

NCT02246179 | Completed Phase 4

• 1 other identifier: NL48655.018.14
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Keywords

Fractional laser; Topical anesthesia; Drug delivery

Outcome Measures

Primary Outcomes (1)

• Pain score

  The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after each pain stimulus.

  Directly after pain stimulus. After 10 minutes incubation time of the anesthetics.

Study Arms (4)

1: AFXL + AHES

EXPERIMENTAL

This test region will be pretreated with a fractional carbon dioxide laser (ablative fractional laser; AFXL) with a 120 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam, single pulse at t0 in a subject blinded fashion. Articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml solution (AHES) will be applied at this test region at t1.Ten minutes after AHES application (incubation time; under occlusion), a pain stimulus will be given at t11 to the subject at the test region using AFXL at 5% density and 35 mJ/microbeam.

Device: AFXL; Drug: AHES

2: AFXL + EMLA

EXPERIMENTAL

This test region will be pretreated with a fractional carbon dioxide laser (ablative fractional laser; AFXL) with a 120 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam, single pulse at t0 in a subject blinded fashion. Eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) will be applied at this test region at t1.Ten minutes after EMLA cream application (incubation time; under occlusion), a pain stimulus will be given at t11 to the subject at the test region using AFXL at 5% density and 35 mJ/microbeam.

Device: AFXL; Drug: EMLA cream

3: Sham AFXL + AHES

SHAM COMPARATOR

A pass with a fractional carbon dioxide laser with a 120 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam, single pulse will be given at the area right adjacent to this test region ("sham AFXL") at t0 in a subject blinded fashion. Articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml solution (AHES) will then be applied at this test region on the intact skin at t1. Ten minutes after AHES application (incubation time; under occlusion), a pain stimulus will be given at t11 to the subject at the test region using AFXL at 5% density and 35 mJ/microbeam.

Device: AFXL; Drug: AHES

4: Sham AFXL + EMLA

SHAM COMPARATOR

A pass with a fractional carbon dioxide laser with a 120 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam, single pulse will be given at the area right adjacent to this test region ("sham AFXL") at t0 in a subject blinded fashion. Eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) will then be applied at this test region on the intact skin at t1. Ten minutes after EMLA cream application (incubation time; under occlusion), a pain stimulus will be given at t11 to the subject at the test region using AFXL at 5% density and 35 mJ/microbeam.

Device: AFXL; Drug: EMLA cream

Interventions

AFXL DEVICE

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

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

1: AFXL + AHES; 2: AFXL + EMLA; 3: Sham AFXL + AHES; 4: Sham AFXL + EMLA

AHES DRUG

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

Also known as: Ultracain D-S forte, articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml

1: AFXL + AHES; 3: Sham AFXL + AHES

EMLA cream DRUG

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

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

2: AFXL + EMLA; 4: Sham AFXL + EMLA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fitzpatrick skin type I or II
• Age ≥18 years
• Patient is willing and able to give written informed consent

You may not qualify if:

• History of keloid or hypertrophic scar formation or complicated wound healing
• Presence of any active skin disease
• 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
• Current treatment with anticoagulants
• Fitzpatrick skin type III-VI
• Excessive sun tan

Sponsors & Collaborators

• Netherlands Institute for Pigment Disorders: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

Netherlands Institute for Pigment disorders

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (13)

• 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: 20166154 BACKGROUND

• 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: 23212624 BACKGROUND

• Oni G, Brown SA, Kenkel JM. Can fractional lasers enhance transdermal absorption of topical lidocaine in an in vivo animal model? Lasers Surg Med. 2012 Feb;44(2):168-74. doi: 10.1002/lsm.21130. Epub 2012 Feb 2.

  PMID: 22302761 BACKGROUND

• 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: 23908302 BACKGROUND

• 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: 22296284 BACKGROUND

• 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: 21841477 BACKGROUND

• Hahn IH, Hoffman RS, Nelson LS. EMLA-induced methemoglobinemia and systemic topical anesthetic toxicity. J Emerg Med. 2004 Jan;26(1):85-8. doi: 10.1016/j.jemermed.2003.03.003.

  PMID: 14751483 BACKGROUND

• 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: 14568832 BACKGROUND

• 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: 17377092 BACKGROUND

• 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: 12355570 BACKGROUND

• 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: 17115384 BACKGROUND

• 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: 23000695 BACKGROUND

• 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: 22348388 BACKGROUND

MeSH Terms

Interventions

Carticaine; Epinephrine; Lidocaine, Prilocaine Drug Combination; Lidocaine; Prilocaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Drug Combinations; Pharmaceutical 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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 22, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 10, 2014

Record last verified: 2014-11

Locations

NL (1)