Fractional Laser Assisted Delivery of Anesthetics III

March 28, 2017 updated by: Netherlands Institute for Pigment Disorders

Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Laser Type and Laser Settings

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale: In dermatology anesthetics are frequently injected or topically applied to achieve local anesthesia. Injectable anesthetics are effective but uncomfortable during administration, especially for people who are needle phobic. Application of topical anesthesia is painless but time consuming and often only partial aesthesia is achieved due to the barrier function of the stratum corneum. (Manuskiatti, Triwongwaranat et al. 2010) Penetration of local anesthetics could be enhanced by pretreatment of the skin with ablative fractional lasers (AFXL) which locally disrupts the stratum corneum by creating an array of microscopic ablation channels. (Sklar, Burnett et al. 2014) In a previous pilot study, conducted at our institute, we demonstrated that effective anesthesia could be achieved within ten minutes after application of a topical anesthetic on skin pretreated with AFXL at painless settings. (Meesters, Bakker et al. 2015) However, little is still known about the role of the type of fractional laser used (e.g. CO2 or Er:YAG laser), the laser settings, the type of anesthetic and the occlusion time on the efficacy of the anesthesia.

Objective: The objectives of this study are to compare the efficacy 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.

Study design: Prospective, single blinded, randomized, controlled, within subject, pilot study.

Study population: 15 healthy volunteers ≥18 years, who give written informed consent Intervention: In each subject, four test regions on subject's back of 1x1 cm will be randomly allocated to (I) pretreatment with the fractional CO2 laser at 5% density, (II) pretreatment with the fractional CO2 laser at 15% density, (III) pretreatment with the fractional Er:YAG laser at 5% density and (IV) pretreatment with the fractional Er:YAG laser at 15% density. After pretreatment, articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml 30 solution (AHES) will be applied on the test regions with 15 minutes occlusion time. After 15 minutes a pain stimulus, consisting of a pass with the fractional CO2 laser at 50 mJ and 5% density (scanned area 6x6 mm), will be given at each test region. In addition, a reference pain stimulus with the CO2 laser at the same settings will be given at unanesthetized skin. Subjects will be asked to indicate pain on a visual analogue scale (VAS) from 0-10 (0: no pain; 10: worst imaginable pain) directly after each pain stimulus.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Netherlands Institute for Pigment Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fractional CO2 laser at 5% density
This test region will be pretreated with a fractional carbon dioxide laser with a 120 μm spot at 5% density and a pulse energy of 2.5 mJ/microbeam (Fractional CO2 laser, 2.5 mJ, 5% density) in a subject blinded fashion. After pretreament Articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml solution (AHES) will be applied to this test region. Fifteen minutes after AHES application (incubation time; under occlusion), a pain stimulus will be given at the test region with the Fractional CO2 laser, 50 mJ, 5% density.
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
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Device: Fractional CO2 laser, 50 mJ, 5% density
Pain stimulus at 50 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Drug: AHES
Topical application at test region I-IV under occlusion for 15 minutes
Other Names:
  • Ultracain D-S forte
  • Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
Experimental: Fractional CO2 laser at 15% density
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 pretreament Articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml solution (AHES) will be applied at this test region. Fifteen minutes after AHES application (incubation time; under occlusion), a pain stimulus will be given at the test region with the Fractional CO2 laser, 50 mJ, 5% density.
Device: Fractional CO2 laser, 50 mJ, 5% density
Pain stimulus at 50 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Drug: AHES
Topical application at test region I-IV under occlusion for 15 minutes
Other Names:
  • Ultracain D-S forte
  • Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
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
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Experimental: Fractional Er:YAG laser at 5% density
This test region will be pretreated with a Erbium Yttrium Aluminum Garnet laser with a 225 μm spot at 5% density and a pulse energy of 9 mJ/microbeam (Fractional Er:YAG laser, 9 mJ, 5% density) in a subject blinded fashion. After pretreatment Articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml solution (AHES) will be applied at this test region. Fifteen minutes after AHES application (incubation time; under occlusion), a pain stimulus will be given at the test region with the Fractional CO2 laser, 50 mJ, 5% density.
Device: Fractional CO2 laser, 50 mJ, 5% density
Pain stimulus at 50 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Drug: AHES
Topical application at test region I-IV under occlusion for 15 minutes
Other Names:
  • Ultracain D-S forte
  • Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
Device: Fractional Er:YAG laser, 9 mJ, 5% density
Pretreatment at 9 mJ and 5% density.
Other Names:
  • Ablative fractional laser
  • Fractional Erbium Yttrium Aluminum Garnet laser
  • P.L.E.A.S.E.® Professional; Pantec Biosolutions
Experimental: Fractional Er:YAG laser at 15% density
This test region will be pretreated with a Erbium Yttrium Aluminum Garnet laser with a 225 μm spot at 15% density and a pulse energy of 9 mJ/microbeam (Fractional Er:YAG laser, 9 mJ, 15% density) in a subject blinded fashion. After pretreatment Articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml solution (AHES) will be applied at this test region. Fifteen minutes after AHES application (incubation time; under occlusion), a pain stimulus will be given at the test region with the Fractional CO2 laser, 50 mJ, 5% density.
Device: Fractional CO2 laser, 50 mJ, 5% density
Pain stimulus at 50 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Drug: AHES
Topical application at test region I-IV under occlusion for 15 minutes
Other Names:
  • Ultracain D-S forte
  • Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
Device: Fractional Er:YAG laser, 9 mJ, 15% density
Pretreatment at 9 mJ and 15% density.
Other Names:
  • Ablative fractional laser
  • Fractional Erbium Yttrium Aluminum Garnet laser
  • P.L.E.A.S.E.® Professional; Pantec Biosolutions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: After 15 minutes incubation time of the anesthetics
The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain).
After 15 minutes incubation time of the anesthetics

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: Directly after pretreatment.
The secondary study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after pretreatment
Directly after pretreatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Netherlands Institute for Pigment Disorders

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

  • Principal Investigator: Albert Wolkerstorfer, MD, PhD, Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam
  • Study Director: Menno A. De Rie, MD, PhD, Department of Dermatology, Academic Medical Center, University of Amsterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 9, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL53766.018.15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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