Fractional Laser Assisted Delivery of Anesthetics IIIb

NCT ID: NCT03279757

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2016-12-01

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.

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

Conditions

Local Anesthesia of the Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

AHES 5 minutes

Intervention Type: DRUG

Topical application of AHES with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

fractional CO2 laser, 50 mJ, 5% density

Intervention Type: DEVICE

Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

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.

Group Type: EXPERIMENTAL

AHES 15 minutes

Intervention Type: DRUG

Topical application of AHES with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

fractional CO2 laser, 50 mJ, 5% density

Intervention Type: DEVICE

Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

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.

Group Type: EXPERIMENTAL

AHES 25 minutes

Intervention Type: DRUG

Topical application of AHES with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

fractional CO2 laser, 50 mJ, 5% density

Intervention Type: DEVICE

Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

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.

Group Type: EXPERIMENTAL

LTC 5 minutes

Intervention Type: DRUG

Topical application of LTC with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

fractional CO2 laser, 50 mJ, 5% density

Intervention Type: DEVICE

Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

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.

Group Type: EXPERIMENTAL

LTC 15 minutes

Intervention Type: DRUG

Topical application of LTC with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

fractional CO2 laser, 50 mJ, 5% density

Intervention Type: DEVICE

Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

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.

Group Type: EXPERIMENTAL

LTC 25 minutes

Intervention Type: DRUG

Topical application of LTC with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

fractional CO2 laser, 50 mJ, 5% density

Intervention Type: DEVICE

Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

Unanesthetized skin

A pain stimulus will be given at unanesthetized skin with the fractional CO2 laser, 50 mJ, 5% density

Group Type: OTHER

fractional CO2 laser, 50 mJ, 5% density

Intervention Type: DEVICE

Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

fractional CO2 laser, 50 mJ, 5% density

Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density

Intervention Type: DEVICE

Other Intervention Names

Ultracain D-S forte; Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml; Ultracain D-S forte; Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml; Ultracain D-S forte; Articaine hydrochloride 40 mg/ml + epinephrine 10 μg/ml; Pliaglis cream; Lidocaine 70 mg/g + tetracaine 70 mg/g cream; Pliaglis cream; Lidocaine 70 mg/g + tetracaine 70 mg/g cream; Pliaglis cream; Lidocaine 70 mg/g + tetracaine 70 mg/g cream; Fractional carbon dioxide laser; UltraPulse®, DeepFx handpiece; Lumenis Inc.; Ablative fractional laser

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Netherlands Institute for Pigment Disorders

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert Wolkerstorfer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam

Menno A De Rie, MD, PhD

Role: STUDY_DIRECTOR

Department of Dermatology, Academic Medical Center, University of Amsterdam

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Other Identifiers

NL53766.018.15b

Identifier Type: -

Identifier Source: org_study_id