Fractional Laser Assisted Delivery of Anesthetics III

Local Anesthesia of the Skin Clinical Trial

Official title:

Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Laser Type and Laser Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938286
• Other study ID #: NL53766.018.15
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2016
• Last updated: March 28, 2017
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Netherlands Institute for Pigment Disorders
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Local Anesthesia of the Skin

Intervention

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
• 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
• Fractional Er:YAG laser, 9 mJ, 5% density
Pretreatment at 9 mJ and 5% density.
• Fractional Er:YAG laser, 9 mJ, 15% density
Pretreatment at 9 mJ and 15% density.
• Fractional CO2 laser, 50 mJ, 5% density
Pain stimulus at 50 mJ/microbeam and 5% density

Drug:
• AHES
Topical application at test region I-IV under occlusion for 15 minutes

Locations

Country	Name	City	State
Netherlands	Netherlands Institute for Pigment Disorders	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Netherlands Institute for Pigment Disorders	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (17)

Bachhav YG, Heinrich A, Kalia YN. Controlled intra- and transdermal protein delivery using a minimally invasive Erbium:YAG fractional laser ablation technology. Eur J Pharm Biopharm. 2013 Jun;84(2):355-64. doi: 10.1016/j.ejpb.2012.11.018. — View Citation

Farkas JP, Richardson JA, Burrus CF, Hoopman JE, Brown SA, Kenkel JM. In vivo histopathologic comparison of the acute injury following treatment with five fractional ablative laser devices. Aesthet Surg J. 2010 May-Jun;30(3):457-64. doi: 10.1177/1090820X10373060. — View Citation

Haak CS, Bhayana B, Farinelli WA, Anderson RR, Haedersdal M. The impact of treatment density and molecular weight for fractional laser-assisted drug delivery. J Control Release. 2012 Nov 10;163(3):335-41. doi: 10.1016/j.jconrel.2012.09.008. Epub 2012 Sep 21. — View Citation

Haak CS, Farinelli WA, Tam J, Doukas AG, Anderson RR, Haedersdal M. Fractional laser-assisted delivery of methyl aminolevulinate: Impact of laser channel depth and incubation time. Lasers Surg Med. 2012 Dec;44(10):787-95. doi: 10.1002/lsm.22102. Epub 2012 Dec 4. Erratum in: Lasers Surg Med. 2013 Nov;45(9):617. — View Citation

Haedersdal M, Sakamoto FH, Farinelli WA, Doukas AG, Tam J, Anderson RR. Fractional CO(2) laser-assisted drug delivery. Lasers Surg Med. 2010 Feb;42(2):113-22. doi: 10.1002/lsm.20860. — View Citation

Hahn IH, Hoffman RS, Nelson LS. EMLA-induced methemoglobinemia and systemic topical anesthetic toxicity. J Emerg Med. 2004 Jan;26(1):85-8. — View Citation

Hantash BM, Bedi VP, Chan KF, Zachary CB. Ex vivo histological characterization of a novel ablative fractional resurfacing device. Lasers Surg Med. 2007 Feb;39(2):87-95. — View Citation

Manuskiatti W, Triwongwaranat D, Varothai S, Eimpunth S, Wanitphakdeedecha R. Efficacy and safety of a carbon-dioxide ablative fractional resurfacing device for treatment of atrophic acne scars in Asians. J Am Acad Dermatol. 2010 Aug;63(2):274-83. doi: 10.1016/j.jaad.2009.08.051. — View Citation

Meesters AA, Bakker MM, de Rie MA, Wolkerstorfer A. Fractional CO2 laser assisted delivery of topical anesthetics: A randomized controlled pilot study. Lasers Surg Med. 2016 Feb;48(2):208-11. doi: 10.1002/lsm.22376. Epub 2015 May 29. — View Citation

Ong MW, Bashir SJ. Fractional laser resurfacing for acne scars: a review. Br J Dermatol. 2012 Jun;166(6):1160-9. doi: 10.1111/j.1365-2133.2012.10870.x. Epub 2012 May 8. Review. — View Citation

Oni G, Brown SA, Kenkel JM. Can fractional lasers enhance transdermal absorption of topical lidocaine in an in vivo animal model? Lasers Surg Med. 2012 Feb;44(2):168-74. doi: 10.1002/lsm.21130. Epub 2012 Feb 2. — View Citation

Oni G, Rasko Y, Kenkel J. Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation. Aesthet Surg J. 2013 Aug 1;33(6):854-61. doi: 10.1177/1090820X13496248. — View Citation

Paasch U, Haedersdal M. Laser systems for ablative fractional resurfacing. Expert Rev Med Devices. 2011 Jan;8(1):67-83. doi: 10.1586/erd.10.74. Review. — View Citation

Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Review. — View Citation

Taudorf EH, Haak CS, Erlendsson AM, Philipsen PA, Anderson RR, Paasch U, Haedersdal M. Fractional ablative erbium YAG laser: histological characterization of relationships between laser settings and micropore dimensions. Lasers Surg Med. 2014 Apr;46(4):281-9. doi: 10.1002/lsm.22228. — View Citation

Tierney EP, Hanke CW. Fractionated carbon dioxide laser treatment of photoaging: prospective study in 45 patients and review of the literature. Dermatol Surg. 2011 Sep;37(9):1279-90. doi: 10.1111/j.1524-4725.2011.02082.x. Review. — View Citation

Wolfe JW, Butterworth JF. Local anesthetic systemic toxicity: update on mechanisms and treatment. Curr Opin Anaesthesiol. 2011 Oct;24(5):561-6. doi: 10.1097/ACO.0b013e32834a9394. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain).	After 15 minutes incubation time of the anesthetics
Secondary	Pain score	The secondary study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after pretreatment	Directly after pretreatment.