The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study
April 2018 | Volume 17 | Issue 4 | Original Article | 413 | Copyright © April 2018
Ravi Jain MBBS MRCGP,a Gerardo Moreno Arias MD PhD,b Pablo Naranjo MD,c Max Murison MD,d Jose Luis López Estebaranz MD PhD,e Alina Fratila MD,f Welf Prager MD,g Carlos Guillén Barona MD,h Michael Weidmann MD,i Serge Dahan MD,j Hugues Cartier MD,k Gerhard Sattler MD,l and Maurizio Podda MD PhDm
aRiverbanks Clinic, Bedfordshire, United Kingdom bCentro Médico Teknon, Barcelona, Spain cElite Laser S.L.P., Madrid, Spain dSwansea Laser Clinic, Swansea Enterprise Park Llans, United Kingdom eDermomedic Clinic, Madrid, Spain fJungbrunnen-Klinik Dr. Fratila GmbH, Bonn, Germany gDr. Prager & Partner, Hamburg, Germany hClínica Dermatológica Dr. Guillén, Valencia, Spain iDres. Dörzapf und Kollegen, Am Forsterpark, Augsburg, Germany jClinique Saint-Jean du Languedoc, Toulouse Cedex 4, France kCentre Médical Saint-Jean, Arras, France lRosenparkklinik GmbH, Darmstadt, Germany mKlinikum Darmstadt Hautklinik, Darmstadt, Germany
Introduction: A variety of topical anesthetic creams are available to reduce pain associated with dermatological procedures. Pliaglis is a self-occluding eutectic mixture of lidocaine and tetracaine.
Study Objectives: To evaluate the post-marketing safety profile of Pliaglis and efficacy in terms of pain reduction, product satisfaction, and daily practice use prior to pre-defined dermatological procedures.
Methods: A prospective, non-interventional study conducted at 44 sites in four European countries; 581 patients were treated prior to dermatological procedures such as pulsed-dye laser therapy, laser-assisted hair removal, non-ablative laser resurfacing, dermal filler injections, and vascular access. Efficacy was assessed by patients and investigators and included pain intensity (visual analogue scale [VAS]), satisfaction, and adequacy of pain relief. Safety was evaluated by adverse event (AE) reporting.
Results: In 75% of the performed procedures, patients scored the pain experienced during the procedure as ≤30 mm on the VAS and most were very satisfied or satisfied with the pain reduction. The investigators assessed the product as providing adequate anesthesia in 97% of the performed procedures and were mostly very satisfied or satisfied with the convenience of use (79%) and tolerability (95%). Twenty-four AEs were reported in 18 (3%) patients.
Discussion: Most patients experienced mild pain only as evident by the ≤ 30 mm VAS scores. Patients and investigators were aligned with regards to both product satisfaction and their opinion on adequacy of pain reduction. The AE frequency was low compared to previous studies, possibly relating to different ways of collecting AEs.
Conclusion: Pliaglis was well-tolerated and provided adequate pain reduction prior to dermatological procedures. www.clinicaltrials.gov (NCT01800474).
J Drugs Dermatol. 2018;17(4):413-418.
Partial study data have been presented at the Anti-Aging Medicine European Congress (AMEC), Paris; October, 24-25, 2014, and the European Academy of Dermatology and Venereology (EADV), Istanbul; October 2-6, 2013.
Dermatological procedures including filler injections and laser treatments can be associated with pain and patient discomfort.1 Injectable anesthetics are often used but may cause distress by themselves, in particular in patients with needle fear.2 These concerns may be counteracted with topical local anesthetics. Most such products contain lidocaine, either alone or in combination with another anesthetic such as prilocaine or tetracaine. Although effective in providing pain relief, they usually require lengthy application times and occlusive dressings to enhance dermis penetration (Discussed in Alster 2013).3