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Fractional Laser Assisted Delivery of Anesthetics III

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ClinicalTrials.gov Identifier: NCT02938286
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : March 29, 2017
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 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.

Condition or disease Intervention/treatment Phase
Local Anesthesia of the Skin Device: Fractional CO2 laser, 2.5 mJ, 5% density Device: Fractional CO2 laser, 2.5 mJ, 15% density Device: Fractional Er:YAG laser, 9 mJ, 5% density Device: Fractional Er:YAG laser, 9 mJ, 15% density Device: Fractional CO2 laser, 50 mJ, 5% density Drug: AHES Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Laser Type and Laser Settings
Study Start Date : March 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

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
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
  • Ablative fractional laser

Device: Fractional CO2 laser, 50 mJ, 5% density
Pain stimulus at 50 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
  • Ablative fractional laser

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, 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
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
  • Ablative fractional laser

Device: Fractional CO2 laser, 50 mJ, 5% density
Pain stimulus at 50 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
  • Ablative fractional laser

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 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 Er:YAG laser, 9 mJ, 5% density
Pretreatment at 9 mJ and 5% density.
Other Names:
  • Fractional Erbium Yttrium Aluminum Garnet laser
  • P.L.E.A.S.E.® Professional; Pantec Biosolutions
  • Ablative fractional laser

Device: Fractional CO2 laser, 50 mJ, 5% density
Pain stimulus at 50 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
  • Ablative fractional laser

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 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 Er:YAG laser, 9 mJ, 15% density
Pretreatment at 9 mJ and 15% density.
Other Names:
  • Fractional Erbium Yttrium Aluminum Garnet laser
  • P.L.E.A.S.E.® Professional; Pantec Biosolutions
  • Ablative fractional laser

Device: Fractional CO2 laser, 50 mJ, 5% density
Pain stimulus at 50 mJ/microbeam and 5% density
Other Names:
  • Fractional carbon dioxide laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
  • Ablative fractional laser

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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



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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): NCT02938286


Locations
Layout table for location information
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
Layout table for investigator information
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:

Layout table for additonal information
Responsible Party: Netherlands Institute for Pigment Disorders
ClinicalTrials.gov Identifier: NCT02938286     History of Changes
Other Study ID Numbers: NL53766.018.15
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Netherlands Institute for Pigment Disorders:
Fractional laser
Topical anesthesia
Drug delivery
CO2 laser
Er:YAG laser

Additional relevant MeSH terms:
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Anesthetics
Carticaine
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anesthetics, Local
Sensory System Agents