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The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study.
J Drugs Dermatol 2018; 17(4):413-418JD

Abstract

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). <p><em>J Drugs Dermatol. 2018;17(4):413-418.</em></p> <p>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.</p>.

Authors

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Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

29601618

Citation

Jain, Ravi, et al. "The Use of a Self-Occluding Topical Anasthetic in Daily Practice: a Non-Interventional Study." Journal of Drugs in Dermatology : JDD, vol. 17, no. 4, 2018, pp. 413-418.
Jain R, Arias GM, Naranjo P, et al. The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study. J Drugs Dermatol. 2018;17(4):413-418.
Jain, R., Arias, G. M., Naranjo, P., Murison, M., López Estebaranz, J. L., Fratila, A., ... Podda, M. (2018). The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study. Journal of Drugs in Dermatology : JDD, 17(4), pp. 413-418.
Jain R, et al. The Use of a Self-Occluding Topical Anasthetic in Daily Practice: a Non-Interventional Study. J Drugs Dermatol. 2018 Apr 1;17(4):413-418. PubMed PMID: 29601618.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study. AU - Jain,Ravi, AU - Arias,Gerardo Moreno, AU - Naranjo,Pablo, AU - Murison,Max, AU - López Estebaranz,Jose Luis, AU - Fratila,Alina, AU - Prager,Welf, AU - Barona,Carlos Guillén, AU - Weidmann,Michael, AU - Dahan,Serge, AU - Cartier,Hugues, AU - Sattler,Gerhard, AU - Podda,Maurizio, PY - 2018/3/31/entrez PY - 2018/3/31/pubmed PY - 2018/9/25/medline SP - 413 EP - 418 JF - Journal of drugs in dermatology : JDD JO - J Drugs Dermatol VL - 17 IS - 4 N2 - 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). <p><em>J Drugs Dermatol. 2018;17(4):413-418.</em></p> <p>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.</p>. SN - 1545-9616 UR - https://www.unboundmedicine.com/medline/citation/29601618/The_Use_of_a_Self-Occluding_Topical_Anasthetic_in_Daily_Practice:_A_Non-Interventional_Study L2 - http://jddonline.com/articles/dermatology/S1545961618P0413X DB - PRIME DP - Unbound Medicine ER -