Fractional Laser Assisted Delivery of Anesthetics IIIb

NCT03279757 | Completed Phase 4

• 1 other identifier: NL53766.018.15b
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study are to compare the efficacy of two different commercially available local anesthetics on AFXL pretreated skin and to assess the role of the application time in this technique.

Conditions

Local Anesthesia of the Skin

Keywords

Fractional laser; Topical anesthesia; Drug delivery; CO2 laser

Outcome Measures

Primary Outcomes (3)

• Pain score

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

  After 5 minutes application time of the anesthetics

• Pain score

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

  After 15 minutes application time of the anesthetics

• Pain score

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

  After 25 minutes application time of the anesthetics

Secondary Outcomes (1)

• Pain score

  Directly after pretreatment.

Study Arms (7)

AHES 5 minutes

EXPERIMENTAL

This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 5 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.

Drug: AHES 5 minutes; Device: fractional CO2 laser, 50 mJ, 5% density

AHES 15 minutes

EXPERIMENTAL

This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 15 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.

Drug: AHES 15 minutes; Device: fractional CO2 laser, 50 mJ, 5% density

AHES 25 minutes

EXPERIMENTAL

This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 25 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.

Drug: AHES 25 minutes; Device: fractional CO2 laser, 50 mJ, 5% density

LTC 5 minutes

EXPERIMENTAL

This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 5 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.

Drug: LTC 5 minutes; Device: fractional CO2 laser, 50 mJ, 5% density

LTC 15 minutes

EXPERIMENTAL

This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 15 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.

Drug: LTC 15 minutes; Device: fractional CO2 laser, 50 mJ, 5% density

LTC 25 minutes

EXPERIMENTAL

This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 15% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 15% density) in a subject blinded fashion. After pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 25 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.

Drug: LTC 25 minutes; Device: fractional CO2 laser, 50 mJ, 5% density

Unanesthetized skin

OTHER

A pain stimulus will be given at unanesthetized skin with the fractional CO2 laser, 50 mJ, 5% density

Device: fractional CO2 laser, 50 mJ, 5% density

Interventions

AHES 5 minutes DRUG

Topical application of AHES with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

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

AHES 5 minutes

AHES 15 minutes DRUG

Topical application of AHES with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

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

AHES 15 minutes

AHES 25 minutes DRUG

Topical application of AHES with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

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

AHES 25 minutes

LTC 5 minutes DRUG

Topical application of LTC with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

Also known as: Pliaglis cream, Lidocaine 70 mg/g + tetracaine 70 mg/g cream

LTC 5 minutes

LTC 15 minutes DRUG

Topical application of LTC with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

Also known as: Pliaglis cream, Lidocaine 70 mg/g + tetracaine 70 mg/g cream

LTC 15 minutes

LTC 25 minutes DRUG

Topical application of LTC with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

Also known as: Pliaglis cream, Lidocaine 70 mg/g + tetracaine 70 mg/g cream

LTC 25 minutes

fractional CO2 laser, 50 mJ, 5% density DEVICE

Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

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

AHES 15 minutes; AHES 25 minutes; AHES 5 minutes; LTC 15 minutes; LTC 25 minutes; LTC 5 minutes; Unanesthetized skin

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

Related Publications (17)

• Meesters AA, Bakker MM, de Rie MA, Wolkerstorfer A. Fractional CO2 laser assisted delivery of topical anesthetics: A randomized controlled pilot study. Lasers Surg Med. 2016 Feb;48(2):208-11. doi: 10.1002/lsm.22376. Epub 2015 May 29.

  PMID: 26032635 BACKGROUND

• Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Epub 2014 Mar 24.

  PMID: 24664987 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

• Manuskiatti W, Triwongwaranat D, Varothai S, Eimpunth S, Wanitphakdeedecha R. Efficacy and safety of a carbon-dioxide ablative fractional resurfacing device for treatment of atrophic acne scars in Asians. J Am Acad Dermatol. 2010 Aug;63(2):274-83. doi: 10.1016/j.jaad.2009.08.051.

  PMID: 20633798 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

• 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

• Bachhav YG, Heinrich A, Kalia YN. Controlled intra- and transdermal protein delivery using a minimally invasive Erbium:YAG fractional laser ablation technology. Eur J Pharm Biopharm. 2013 Jun;84(2):355-64. doi: 10.1016/j.ejpb.2012.11.018. Epub 2012 Nov 30.

  PMID: 23207321 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

• 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

• Tierney EP, Hanke CW. Fractionated carbon dioxide laser treatment of photoaging: prospective study in 45 patients and review of the literature. Dermatol Surg. 2011 Sep;37(9):1279-90. doi: 10.1111/j.1524-4725.2011.02082.x.

  PMID: 22988990 BACKGROUND

• Paasch U, Haedersdal M. Laser systems for ablative fractional resurfacing. Expert Rev Med Devices. 2011 Jan;8(1):67-83. doi: 10.1586/erd.10.74.

  PMID: 21158542 BACKGROUND

• Farkas JP, Richardson JA, Burrus CF, Hoopman JE, Brown SA, Kenkel JM. In vivo histopathologic comparison of the acute injury following treatment with five fractional ablative laser devices. Aesthet Surg J. 2010 May-Jun;30(3):457-64. doi: 10.1177/1090820X10373060.

  PMID: 20601578 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

• Taudorf EH, Haak CS, Erlendsson AM, Philipsen PA, Anderson RR, Paasch U, Haedersdal M. Fractional ablative erbium YAG laser: histological characterization of relationships between laser settings and micropore dimensions. Lasers Surg Med. 2014 Apr;46(4):281-9. doi: 10.1002/lsm.22228. Epub 2014 Feb 5.

  PMID: 24500855 BACKGROUND

MeSH Terms

Interventions

Carticaine; Epinephrine; Lidocaine; Tetracaine

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; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids

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 3, 2017
• First Posted: September 12, 2017
• Study Start: October 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 12, 2017

Record last verified: 2017-09