A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up

Tahera Bhojani-Lynch,1 Anne Deckers,2 Ohan Ohanes,3 Kevin Poupard,4 Pauline Maffert4 1The Laser and Light Clinic, Loughborough, UK; 2Centre Médical Esthétique Eureka, Dalhem, Belgium; 3Swiss Care Cosmetic & Laser Clinic, London, UK; 4Clinical Development Department, Teoxane S.A., Geneva, Switzer...

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Autores principales:	Bhojani-Lynch T, Deckers A, Ohanes O, Poupard K, Maffert P
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	aesthetic facial rejuvenation nonsurgical real-world evidence registry Dermatology RL1-803
Acceso en línea:	https://doaj.org/article/06a3ddd5704148ceaa8efbfe6b50f06a
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spelling	oai:doaj.org-article:06a3ddd5704148ceaa8efbfe6b50f06a2021-11-16T18:47:51ZA Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up1178-7015https://doaj.org/article/06a3ddd5704148ceaa8efbfe6b50f06a2021-11-01T00:00:00Zhttps://www.dovepress.com/a-prospective-observational-registry-study-to-evaluate-effectiveness-a-peer-reviewed-fulltext-article-CCIDhttps://doaj.org/toc/1178-7015Tahera Bhojani-Lynch,1 Anne Deckers,2 Ohan Ohanes,3 Kevin Poupard,4 Pauline Maffert4 1The Laser and Light Clinic, Loughborough, UK; 2Centre Médical Esthétique Eureka, Dalhem, Belgium; 3Swiss Care Cosmetic & Laser Clinic, London, UK; 4Clinical Development Department, Teoxane S.A., Geneva, SwitzerlandCorrespondence: Pauline MaffertTeoxane S.A., Rue de Lyon 105, Geneva, 1203, SwitzerlandTel +41 22 344 96 36Email p.maffert@teoxane.comBackground: Monitoring the effectiveness, safety and emerging uses of hyaluronic acid (HA) fillers in their wide range of indications requires a holistic approach.Purpose: To propose an observational study design aiming to gather real-world evidence (RWE) and continuously evaluate the performance and safety of marketed devices in routine practice.Materials and Methods: A prospective, observational registry was initiated at six European sites. Investigators enrolled any subject receiving at least one injection with a target study device (TEOSYAL Deep Lines [HADL] and/or Global Action [HAGA]). They followed their routine practice regarding injection technique, volume, and subject follow-up. Effectiveness was evaluated at 3 months using the global aesthetic improvement scale (GAIS). Safety was assessed based on common treatment reactions (CTR) and adverse events (AE).Results: High quantity of RWE was collected following the initiation of this registry. In the first 158 subjects enrolled, 1220 injections were performed in more than 25 indications, including 679 with the target devices and 271 with devices of the same filler line. The primary objective was achieved, with 93.9% of treatments providing improvement at Month 3 according to the PI and subject. Post-injection CTR were mild to moderate and short-lived, and there was no clinically significant AE. More than 76% of treatments still provided some visible effect at month 12.Conclusion: Based on RWE, HADL and HAGL are effective and safe in their respective indications mostly distributed in the midface, perioral region, and lower face. Observational registries are a valuable asset in the context of post-market clinical follow-up.Keywords: aesthetic, facial rejuvenation, nonsurgical, real-world evidence, registryBhojani-Lynch TDeckers AOhanes OPoupard KMaffert PDove Medical Pressarticleaestheticfacial rejuvenationnonsurgicalreal-world evidenceregistryDermatologyRL1-803ENClinical, Cosmetic and Investigational Dermatology, Vol Volume 14, Pp 1685-1695 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	aesthetic facial rejuvenation nonsurgical real-world evidence registry Dermatology RL1-803
spellingShingle	aesthetic facial rejuvenation nonsurgical real-world evidence registry Dermatology RL1-803 Bhojani-Lynch T Deckers A Ohanes O Poupard K Maffert P A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up
description	Tahera Bhojani-Lynch,1 Anne Deckers,2 Ohan Ohanes,3 Kevin Poupard,4 Pauline Maffert4 1The Laser and Light Clinic, Loughborough, UK; 2Centre Médical Esthétique Eureka, Dalhem, Belgium; 3Swiss Care Cosmetic & Laser Clinic, London, UK; 4Clinical Development Department, Teoxane S.A., Geneva, SwitzerlandCorrespondence: Pauline MaffertTeoxane S.A., Rue de Lyon 105, Geneva, 1203, SwitzerlandTel +41 22 344 96 36Email p.maffert@teoxane.comBackground: Monitoring the effectiveness, safety and emerging uses of hyaluronic acid (HA) fillers in their wide range of indications requires a holistic approach.Purpose: To propose an observational study design aiming to gather real-world evidence (RWE) and continuously evaluate the performance and safety of marketed devices in routine practice.Materials and Methods: A prospective, observational registry was initiated at six European sites. Investigators enrolled any subject receiving at least one injection with a target study device (TEOSYAL Deep Lines [HADL] and/or Global Action [HAGA]). They followed their routine practice regarding injection technique, volume, and subject follow-up. Effectiveness was evaluated at 3 months using the global aesthetic improvement scale (GAIS). Safety was assessed based on common treatment reactions (CTR) and adverse events (AE).Results: High quantity of RWE was collected following the initiation of this registry. In the first 158 subjects enrolled, 1220 injections were performed in more than 25 indications, including 679 with the target devices and 271 with devices of the same filler line. The primary objective was achieved, with 93.9% of treatments providing improvement at Month 3 according to the PI and subject. Post-injection CTR were mild to moderate and short-lived, and there was no clinically significant AE. More than 76% of treatments still provided some visible effect at month 12.Conclusion: Based on RWE, HADL and HAGL are effective and safe in their respective indications mostly distributed in the midface, perioral region, and lower face. Observational registries are a valuable asset in the context of post-market clinical follow-up.Keywords: aesthetic, facial rejuvenation, nonsurgical, real-world evidence, registry
format	article
author	Bhojani-Lynch T Deckers A Ohanes O Poupard K Maffert P
author_facet	Bhojani-Lynch T Deckers A Ohanes O Poupard K Maffert P
author_sort	Bhojani-Lynch T
title	A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up
title_short	A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up
title_full	A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up
title_fullStr	A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up
title_full_unstemmed	A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up
title_sort	prospective, observational registry study to evaluate effectiveness and safety of hyaluronic acid-based dermal fillers in routine practice: interim analysis results with one year of subject follow-up
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/06a3ddd5704148ceaa8efbfe6b50f06a
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A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up

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