drugset / Trial / NCT02548533
Fractional Laser Assisted Topical Anesthesia
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy of skin anesthesia using fractional laser assisted delivery of articaine hydrochloride 40 mg/ml and epinephrine 10 µg/ml solution (AHES) compared to standard anesthesia with topical eutectic mixture of lidocaine 25 mg/g and prilocaine 25 mg/g cream (EMLA cream) prior to ablative fractional laser treatment of acne scars and traumatic scars.
Timeline
- Start
- 2015-06
- Primary completion
- 2016-01
- Completion
- 2016-01
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background Koh JL, Harrison D, Swanson V, Norvell DC, Coomber DC. A comparison of laser-assisted drug delivery at two output energies for enhancing the delivery of topically applied LMX-4 cream prior to venipuncture. Anesth Analg. 2007 Apr;104(4):847-9. doi: 10.1213/01.ane.0000257925.36641.9e.
- Background Baron ED, Harris L, Redpath WS, Shapiro H, Hetzel F, Morley G, Bar-Or D, Stevens SR. Laser-assisted penetration of topical anesthetic in adults. Arch Dermatol. 2003 Oct;139(10):1288-90. doi: 10.1001/archderm.139.10.1288.
- Background Shapiro H, Harris L, Hetzel FW, Bar-Or D. Laser assisted delivery of topical anesthesia for intramuscular needle insertion in adults. Lasers Surg Med. 2002;31(4):252-6. doi: 10.1002/lsm.10101.
- Background Togsverd-Bo K, Haak CS, Thaysen-Petersen D, Wulf HC, Anderson RR, Haedersdal M. Intensified photodynamic therapy of actinic keratoses with fractional CO2 laser: a randomized clinical trial. Br J Dermatol. 2012 Jun;166(6):1262-9. doi: 10.1111/j.1365-2133.2012.10893.x.
- Background 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. doi: 10.1002/lsm.20405.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Articaine | Other / unclassified | 40 mg/ml | Topical |
| Subject | Epinephrine | Other / unclassified | 10 ug/ml | Topical |
| Comparator | Lidocaine | Other / unclassified | 25 unknown | Topical |
| Comparator | prilocaine | Small molecule | 25 unknown | Topical |
Indications
No indication recorded.