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Fractional Laser Assisted Topical Anesthesia

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ClinicalTrials.gov Identifier: NCT02548533
Recruitment Status : Terminated (Not enough patients eligible for recruitment.)
First Posted : September 14, 2015
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Netherlands Institute for Pigment Disorders

Brief Summary:
The purpose of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) prior to ablative fractional laser treatment of acne scars and traumatic scars.

Condition or disease Intervention/treatment Phase
Cicatrix 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, Haedersdal and colleagues have shown that the penetration of various topically applied substances, including photosensitizers, into the skin can be enhanced and accelerated by pretreatment of the skin with a fractional laser, creating a pattern of microscopic ablation craters.1 This improvement in drug penetration is regardless of ablation crater depth.2 There is limited evidence that transepidermal lidocaine absorption can be increased by fractional laser pretreatment.3, 4 These findings might suggest that local anesthesia of the skin may be achieved by applying an anesthetic topically on a skin surface pretreated with a fractional laser. The investigators of the present study hypothesize that fractional laser assisted delivery of topical anesthetics might give a faster and better anesthetic effect, than treatment with the standard treatment of topical anesthesia.

Objective: The objective of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream).

Study design: Prospective, open label, randomized controlled, within subject, study.

Study population: patients >18 years, who give written informed consent, visiting the institute for fractional carbon dioxide laser treatment for acne scars or traumatic scars.

Intervention (if applicable): In each patient, the lesional area will be divided into two comparable regions during the visit prior to the (next) fractional laser treatment. These regions will then be randomly allocated to either standard anesthesia with EMLA cream (control region; region I) or ablative fractional laser (AFXL) assisted delivery of AHES (intervention region; region II). Patients will be asked to apply EMLA cream at region I under occlusion two hours prior to the laser treatment. Fifteen minutes before the therapeutic laser treatment of the scars, the skin of region II will be pretreated with the fractional carbon dioxide laser (15% density, 2.5 mJ/microbeam). Directly following fractional laser pretreatment, AHES will be topically applied under occlusion at region II for 15 minutes. Subsequently treatment of both regions will be performed with the same fractional carbon dioxide laser at the settings used in routine clinical practice. Directly after this therapeutic laser treatment, patients will be asked to indicate pain per test region on a visual analogue scale (VAS) from 0-10 (0: no pain; 10: worst imaginable pain).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fractional CO2 Laser Assisted Topical Articaine Anesthesia vs. Topical EMLA Administration: a Randomized Controlled Study
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Active Comparator: Region 1
Standard topical anesthesia using eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) applied two hours before treatment.
Drug: EMLA cream
Topical application 2 hours prior to the treatment.
Other Name: lidocaine 25 mg/g + prilocaine 25 mg/g cream

Experimental: Region 2
Anesthesia using articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) applied on ablative fractional laser (AFXL) pretreated skin 15 minutes prior to the treatment.
Device: AFXL
Pretreatment at 2.5 mJ/microbeam and 15% density.
Other Names:
  • Fractional carbon dioxide laser
  • Ablative fractional laser
  • Fractional CO2 laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.

Drug: AHES
Topical application on AFXL pretreated skin 15 minutes prior to the treatment.
Other Names:
  • Ultracain DS Forte
  • articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml




Primary Outcome Measures :
  1. Pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) at each of both regions. [ Time Frame: < 1 minute after AFXL treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acne scars or traumatic scars scheduled for treatment with the fractional carbon dioxide laser
  • Age ≥18 years
  • Patient is willing and able to give written informed consent

Exclusion Criteria:

  • 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
  • Total lesional area to be treated in one session >600 cm2

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): NCT02548533


Locations
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Netherlands
Netherlands Institute for Pigment disorders
Amsterdam, Netherlands, 1105AZ
Sponsors and Collaborators
Netherlands Institute for Pigment Disorders
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: NCT02548533     History of Changes
Other Study ID Numbers: NL49394.018.14
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Anesthetics
Anesthetics, Local
Anesthetics, Combined
Cicatrix
Fibrosis
Pathologic Processes
Lidocaine
Epinephrine
Prilocaine
Carticaine
Lidocaine, Prilocaine Drug Combination
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