Fractional Laser Assisted Delivery of Anesthetics

November 7, 2014 updated by: Netherlands Institute for Pigment Disorders

Fractional Carbon Dioxide Laser Assisted Delivery of Topical Anesthetics: a Randomized Controlled Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale: In dermatology, many minor surgical and laser procedures are carried out under local anesthesia of the skin. Anesthesia using topical formulations is time consuming, as the anesthetic has to be applied at least one hour before treatment, and is often only partially effective. On the other hand infiltration anesthesia is often associated with discomfort and is not tolerated by patients who are for example needle phobic. In the past years, enhanced and accelerated penetration of various topically applied substances, including photosensitizers, has been proven by pretreatment of the skin with a fractional laser, creating a pattern of microscopic ablation craters.(Haedersdal et al., 2010) This improvement in drug penetration seems to be regardless of ablation crater depth.(Haak et al., 2012) There is limited evidence that transdermal lidocaine absorption can be increased by fractional laser pretreatment.(Oni et al., 2012; Oni et al., 2013) These findings might suggest that local anesthesia of the skin may be achieved by applying an anesthetic drug topically on a skin surface pretreated with a fractional laser. However, little is known about the role of the formulation of the topical drug delivered using this method.

Objective: The primary objective of this study is to assess the analgesic effect of fractional carbon dioxide laser assisted delivery of two topical anesthetics (articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml solution (AHES) and EMLA cream) compared to application of these anesthetics without fractional laser pretreatment. The secondary objective is to compare the efficacy of these two different anesthetics, when applied according to the fractional laser drug delivery principle.

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

Study population: 10 healthy volunteers ≥18 years, who give written informed consent Intervention: In each subject, four test regions on subject's back of 1x1 centimeter will be randomly allocated in a 2x2 design to (1) ablative fractional laser (AFXL) pretreatment (5% density, 2.5 mJ/microbeam) followed by topical application of AHES, (2) AFXL pretreatment followed by application of EMLA cream, (3) sham AFXL followed by application of AHES on the intact skin and (4) sham AFXL followed by application of EMLA cream on the intact skin. Sham AFXL will be done by delivering an AFXL pass at 5% density and 2.5 mJ/microbeam right adjacent to the region of AHES or EMLA application on the intact skin. After ten minutes incubation time, an AFXL pass will be given as a pain stimulus at each test region with 5% density and 35 mJ/microbeam. 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)

10

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

No

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: 1: AFXL + AHES
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
Pretreatment at 2.5 mJ/microbeam and 5% density Pain stimulus at 35 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • Fractional CO2 laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Drug: AHES
Topical application at test region 1 and 3 under occlusion for 10 minutes
Other Names:
  • Ultracain D-S forte
  • articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
Experimental: 2: AFXL + EMLA
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
Pretreatment at 2.5 mJ/microbeam and 5% density Pain stimulus at 35 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • Fractional CO2 laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Drug: EMLA cream
Topical application at test region 2 and 4 under occlusion for 10 minutes
Other Names:
  • lidocaine 25 mg/g + prilocaine 25 mg/g cream
Sham Comparator: 3: Sham AFXL + AHES
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
Pretreatment at 2.5 mJ/microbeam and 5% density Pain stimulus at 35 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • Fractional CO2 laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Drug: AHES
Topical application at test region 1 and 3 under occlusion for 10 minutes
Other Names:
  • Ultracain D-S forte
  • articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
Sham Comparator: 4: Sham AFXL + EMLA
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
Pretreatment at 2.5 mJ/microbeam and 5% density Pain stimulus at 35 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • Fractional CO2 laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
Drug: EMLA cream
Topical application at test region 2 and 4 under occlusion for 10 minutes
Other Names:
  • lidocaine 25 mg/g + prilocaine 25 mg/g cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: Directly after pain stimulus. After 10 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) directly after each pain stimulus.
Directly after pain stimulus. After 10 minutes incubation time of the anesthetics.

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

September 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL48655.018.14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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