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Fractional Laser Assisted Delivery of Anesthetics IIIb

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ClinicalTrials.gov Identifier: NCT03279757
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Netherlands Institute for Pigment Disorders

Brief Summary:
The purpose of this study are to compare the efficacy of two different commercially available local anesthetics on AFXL pretreated skin and to assess the role of the application time in this technique.

Condition or disease Intervention/treatment Phase
Local Anesthesia of the Skin Drug: AHES 5 minutes Drug: AHES 15 minutes Drug: AHES 25 minutes Drug: LTC 5 minutes Drug: LTC 15 minutes Drug: LTC 25 minutes Device: fractional CO2 laser, 50 mJ, 5% density 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 anesthetic the type of anesthetic and the application time on the efficacy of the anesthesia.

Objective: The objective of this study is to compare the efficacy of two different commercially available local anesthetics on AFXL pretreated skin, a low concentration articaine solution and a high concentration lidocaine/tetracaine cream. We also aim to compare the efficacy of AFXL assisted topical anesthesia after various different application times.

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, six test regions on subject's back of 1x1 cm will be pretreated with the fractional carbon dioxide (CO2) laser at 2.5 mJ and 15% density and will be randomly allocated to application of (I) articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml 30 solution (AHES) (5 minutes application time), (II) AHES (15 minutes application time), (III) AHES (25 minutes application time), (IV) lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) (5 minutes application time, (V) LTC (15 minutes application time), (VI) LTC (25 minutes application 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


Layout table for study information
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 Anesthetic and Application Time
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Arm Intervention/treatment
Experimental: AHES 5 minutes
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 pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 5 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.
Drug: AHES 5 minutes
Topical application of AHES with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
Other Names:
  • Ultracain D-S forte
  • Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml

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

Experimental: AHES 15 minutes
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 pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 15 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.
Drug: AHES 15 minutes
Topical application of AHES with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
Other Names:
  • Ultracain D-S forte
  • Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml

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

Experimental: AHES 25 minutes
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 pretreatment articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml solution (AHES) will be applied at this test region. 25 minutes after AHES application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.
Drug: AHES 25 minutes
Topical application of AHES with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
Other Names:
  • Ultracain D-S forte
  • Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml

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

Experimental: LTC 5 minutes
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 pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 5 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.
Drug: LTC 5 minutes
Topical application of LTC with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
Other Names:
  • Pliaglis cream
  • Lidocaine 70 mg/g + tetracaine 70 mg/g cream

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

Experimental: LTC 15 minutes
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 pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 15 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.
Drug: LTC 15 minutes
Topical application of LTC with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
Other Names:
  • Pliaglis cream
  • Lidocaine 70 mg/g + tetracaine 70 mg/g cream

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

Experimental: LTC 25 minutes
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 pretreatment lidocaine 70 mg/g + tetracaine 70 mg/g cream (LTC) will be applied at this test region. 25 minutes after LTC application (under occlusion), a pain stimulus will be given at the test region with the fractional CO2 laser, 50 mJ, 5% density.
Drug: LTC 25 minutes
Topical application of LTC with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
Other Names:
  • Pliaglis cream
  • Lidocaine 70 mg/g + tetracaine 70 mg/g cream

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

Unanesthetized skin
A pain stimulus will be given at unanesthetized skin with the fractional CO2 laser, 50 mJ, 5% density
Device: fractional CO2 laser, 50 mJ, 5% density
Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
Other Names:
  • Fractional carbon dioxide laser
  • UltraPulse®, DeepFx handpiece; Lumenis Inc.
  • Ablative fractional laser




Primary Outcome Measures :
  1. Pain score [ Time Frame: After 5 minutes application 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).

  2. Pain score [ Time Frame: After 15 minutes application 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).

  3. Pain score [ Time Frame: After 25 minutes application 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



Information from the National Library of Medicine

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Layout table for eligibility information
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): NCT03279757


Sponsors and Collaborators
Netherlands Institute for Pigment Disorders
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: NCT03279757     History of Changes
Other Study ID Numbers: NL53766.018.15b
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Layout table for additional information
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
Keywords provided by Netherlands Institute for Pigment Disorders:
Fractional laser
Topical anesthesia
Drug delivery
CO2 laser
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Anesthetics, Local
Lidocaine
Epinephrine
Racepinephrine
Tetracaine
Carticaine
Epinephryl borate
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