Fractional Laser Assisted Delivery of Anesthetics III

Netherlands Institute for Pigment Disorders

Status and phase: Completed; Phase 4

Conditions: Local Anesthesia of the Skin

Treatments: Device: Fractional CO2 laser, 2.5 mJ, 15% density; Device: Fractional Er:YAG laser, 9 mJ, 5% density; Drug: AHES; Device: Fractional CO2 laser, 50 mJ, 5% density; Device: Fractional Er:YAG laser, 9 mJ, 15% density; Device: Fractional CO2 laser, 2.5 mJ, 5% density

Study type: Interventional

Funder types: Other

Identifiers

NCT02938286

NL53766.018.15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

15 participants in 4 patient groups

Fractional CO2 laser at 5% density

Experimental group

Description:

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.

Treatment:

Device: Fractional CO2 laser, 2.5 mJ, 5% density

Device: Fractional CO2 laser, 50 mJ, 5% density

Drug: AHES

Fractional CO2 laser at 15% density

Experimental group

Description:

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.

Treatment:

Device: Fractional CO2 laser, 50 mJ, 5% density

Drug: AHES

Device: Fractional CO2 laser, 2.5 mJ, 15% density

Fractional Er:YAG laser at 5% density

Experimental group

Description:

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.

Treatment:

Device: Fractional CO2 laser, 50 mJ, 5% density

Drug: AHES

Device: Fractional Er:YAG laser, 9 mJ, 5% density

Fractional Er:YAG laser at 15% density

Experimental group

Description:

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.

Treatment:

Device: Fractional CO2 laser, 50 mJ, 5% density

Device: Fractional Er:YAG laser, 9 mJ, 15% density

Drug: AHES