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Fractional Laser Assisted Delivery of Anesthetics

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ClinicalTrials.gov Identifier: NCT02246179
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : November 10, 2014
Sponsor:
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Netherlands Institute for Pigment Disorders

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.

Condition or disease Intervention/treatment Phase
Local Anesthesia of the Skin. Device: AFXL Drug: AHES Drug: EMLA cream Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fractional Carbon Dioxide Laser Assisted Delivery of Topical Anesthetics: a Randomized Controlled Pilot Study
Study Start Date : September 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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 Name: 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 Name: lidocaine 25 mg/g + prilocaine 25 mg/g cream




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246179


Locations
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Netherlands
Netherlands Institute for Pigment disorders
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Netherlands Institute for Pigment Disorders
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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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:

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Responsible Party: Netherlands Institute for Pigment Disorders
ClinicalTrials.gov Identifier: NCT02246179     History of Changes
Other Study ID Numbers: NL48655.018.14
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014
Keywords provided by Netherlands Institute for Pigment Disorders:
Fractional laser
Topical anesthesia
Drug delivery
Additional relevant MeSH terms:
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Lidocaine
Epinephrine
Racepinephrine
Prilocaine
Lidocaine, Prilocaine Drug Combination
Carticaine
Anesthetics
Epinephryl borate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents