<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02246179</url>
  </required_header>
  <id_info>
    <org_study_id>NL48655.018.14</org_study_id>
    <nct_id>NCT02246179</nct_id>
  </id_info>
  <brief_title>Fractional Laser Assisted Delivery of Anesthetics</brief_title>
  <official_title>Fractional Carbon Dioxide Laser Assisted Delivery of Topical Anesthetics: a Randomized Controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Netherlands Institute for Pigment Disorders</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Netherlands Institute for Pigment Disorders</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of fractional CO2 laser assisted delivery&#xD;
      of topically applied anesthetics (articaine hydrochloride 40 mg/ml and epinephrine 10 μg/ml&#xD;
      solution and EMLA cream) regarding to anesthesia of the skin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: In dermatology, many minor surgical and laser procedures are carried out under&#xD;
      local anesthesia of the skin. Anesthesia using topical formulations is time consuming, as the&#xD;
      anesthetic has to be applied at least one hour before treatment, and is often only partially&#xD;
      effective. On the other hand infiltration anesthesia is often associated with discomfort and&#xD;
      is not tolerated by patients who are for example needle phobic. In the past years, enhanced&#xD;
      and accelerated penetration of various topically applied substances, including&#xD;
      photosensitizers, has been proven by pretreatment of the skin with a fractional laser,&#xD;
      creating a pattern of microscopic ablation craters.(Haedersdal et al., 2010) This improvement&#xD;
      in drug penetration seems to be regardless of ablation crater depth.(Haak et al., 2012) There&#xD;
      is limited evidence that transdermal lidocaine absorption can be increased by fractional&#xD;
      laser pretreatment.(Oni et al., 2012; Oni et al., 2013) These findings might suggest that&#xD;
      local anesthesia of the skin may be achieved by applying an anesthetic drug topically on a&#xD;
      skin surface pretreated with a fractional laser. However, little is known about the role of&#xD;
      the formulation of the topical drug delivered using this method.&#xD;
&#xD;
      Objective: The primary objective of this study is to assess the analgesic effect of&#xD;
      fractional carbon dioxide laser assisted delivery of two topical anesthetics (articaine&#xD;
      hydrochloride 40 mg/ml and epinephrine 10 μg/ml solution (AHES) and EMLA cream) compared to&#xD;
      application of these anesthetics without fractional laser pretreatment. The secondary&#xD;
      objective is to compare the efficacy of these two different anesthetics, when applied&#xD;
      according to the fractional laser drug delivery principle.&#xD;
&#xD;
      Study design: Prospective, single blinded, randomized, controlled, within subject, pilot&#xD;
      study.&#xD;
&#xD;
      Study population: 10 healthy volunteers ≥18 years, who give written informed consent&#xD;
      Intervention: In each subject, four test regions on subject's back of 1x1 centimeter will be&#xD;
      randomly allocated in a 2x2 design to (1) ablative fractional laser (AFXL) pretreatment (5%&#xD;
      density, 2.5 mJ/microbeam) followed by topical application of AHES, (2) AFXL pretreatment&#xD;
      followed by application of EMLA cream, (3) sham AFXL followed by application of AHES on the&#xD;
      intact skin and (4) sham AFXL followed by application of EMLA cream on the intact skin. Sham&#xD;
      AFXL will be done by delivering an AFXL pass at 5% density and 2.5 mJ/microbeam right&#xD;
      adjacent to the region of AHES or EMLA application on the intact skin. After ten minutes&#xD;
      incubation time, an AFXL pass will be given as a pain stimulus at each test region with 5%&#xD;
      density and 35 mJ/microbeam. Subjects will be asked to indicate pain on a visual analogue&#xD;
      scale (VAS) from 0-10 (0: no pain; 10: worst imaginable pain) directly after each pain&#xD;
      stimulus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>Directly after pain stimulus. After 10 minutes incubation time of the anesthetics.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Local Anesthesia of the Skin.</condition>
  <arm_group>
    <arm_group_label>1: AFXL + AHES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2: AFXL + EMLA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3: Sham AFXL + AHES</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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 (&quot;sham AFXL&quot;) 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4: Sham AFXL + EMLA</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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 (&quot;sham AFXL&quot;) 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AFXL</intervention_name>
    <description>Pretreatment at 2.5 mJ/microbeam and 5% density Pain stimulus at 35 mJ/microbeam and 5% density</description>
    <arm_group_label>1: AFXL + AHES</arm_group_label>
    <arm_group_label>2: AFXL + EMLA</arm_group_label>
    <arm_group_label>3: Sham AFXL + AHES</arm_group_label>
    <arm_group_label>4: Sham AFXL + EMLA</arm_group_label>
    <other_name>Fractional carbon dioxide laser</other_name>
    <other_name>Ablative fractional laser</other_name>
    <other_name>Fractional CO2 laser</other_name>
    <other_name>UltraPulse®, DeepFx handpiece; Lumenis Inc.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AHES</intervention_name>
    <description>Topical application at test region 1 and 3 under occlusion for 10 minutes</description>
    <arm_group_label>1: AFXL + AHES</arm_group_label>
    <arm_group_label>3: Sham AFXL + AHES</arm_group_label>
    <other_name>Ultracain D-S forte</other_name>
    <other_name>articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EMLA cream</intervention_name>
    <description>Topical application at test region 2 and 4 under occlusion for 10 minutes</description>
    <arm_group_label>2: AFXL + EMLA</arm_group_label>
    <arm_group_label>4: Sham AFXL + EMLA</arm_group_label>
    <other_name>lidocaine 25 mg/g + prilocaine 25 mg/g cream</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fitzpatrick skin type I or II&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Patient is willing and able to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of keloid or hypertrophic scar formation or complicated wound healing&#xD;
&#xD;
          -  Presence of any active skin disease&#xD;
&#xD;
          -  Known allergy to local anesthesia&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Incompetency to understand what the procedure involves&#xD;
&#xD;
          -  Current complaints of chronic pain or other alterations in pain sensation (e.g. due to&#xD;
             diabetes mellitus or lepra)&#xD;
&#xD;
          -  Current treatment with systemic analgesics or other medication that can influence pain&#xD;
             sensation&#xD;
&#xD;
          -  Current treatment with anticoagulants&#xD;
&#xD;
          -  Fitzpatrick skin type III-VI&#xD;
&#xD;
          -  Excessive sun tan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Albert Wolkerstorfer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Menno A. De Rie, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Dermatology, Academic Medical Center, University of Amsterdam</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Netherlands Institute for Pigment disorders</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20166154</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: Lasers Surg Med. 2013 Nov;45(9):617.</citation>
    <PMID>23212624</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22302761</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23908302</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22296284</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21841477</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14751483</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14568832</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17377092</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12355570</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17115384</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23000695</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: Br J Dermatol. 2012 Aug;167(2):461. Haedesdal, M [corrected to Haedersdal, M].</citation>
    <PMID>22348388</PMID>
  </reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>November 7, 2014</last_update_submitted>
  <last_update_submitted_qc>November 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fractional laser</keyword>
  <keyword>Topical anesthesia</keyword>
  <keyword>Drug delivery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Prilocaine</mesh_term>
    <mesh_term>Carticaine</mesh_term>
    <mesh_term>Lidocaine, Prilocaine Drug Combination</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02246179
org study id: NL48655.018.14
nct id: NCT02246179
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain score
time frame: Directly after pain stimulus. After 10 minutes incubation time of the anesthetics.
description: 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.
arm group label: 1: AFXL + AHES
arm group type: Experimental
description: 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.
arm group label: 2: AFXL + EMLA
arm group type: Experimental
description: 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.
arm group label: 3: Sham AFXL + AHES
arm group type: Sham Comparator
description: 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.
arm group label: 4: Sham AFXL + EMLA
arm group type: Sham Comparator
description: 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.
intervention type: Device
intervention name: AFXL
description: Pretreatment at 2.5 mJ/microbeam and 5% density Pain stimulus at 35 mJ/microbeam and 5% density
arm group label: 1: AFXL + AHES
arm group label: 2: AFXL + EMLA
arm group label: 3: Sham AFXL + AHES
arm group label: 4: Sham AFXL + EMLA
other name: Fractional carbon dioxide laser
other name: Ablative fractional laser
other name: Fractional CO2 laser
other name: UltraPulse®, DeepFx handpiece; Lumenis Inc.
intervention type: Drug
intervention name: AHES
description: Topical application at test region 1 and 3 under occlusion for 10 minutes
arm group label: 1: AFXL + AHES
arm group label: 3: Sham AFXL + AHES
other name: Ultracain D-S forte
other name: articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml
intervention type: Drug
intervention name: EMLA cream
description: Topical application at test region 2 and 4 under occlusion for 10 minutes
arm group label: 2: AFXL + EMLA
arm group label: 4: Sham AFXL + EMLA
other name: lidocaine 25 mg/g + prilocaine 25 mg/g cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Albert Wolkerstorfer, MD, PhD
role: Principal Investigator
affiliation: Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam
last name: Menno A. De Rie, MD, PhD
role: Study Director
affiliation: Department of Dermatology, Academic Medical Center, University of Amsterdam
facility: 
country: Netherlands
citation: 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
citation: 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. Erratum In: Lasers Surg Med. 2013 Nov;45(9):617.
PMID: 23212624
citation: 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
citation: 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
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responsible party type: Sponsor
mesh term: Lidocaine
mesh term: Epinephrine
mesh term: Prilocaine
mesh term: Carticaine
mesh term: Lidocaine, Prilocaine Drug Combination