A 12-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Severe Nasolabial Folds

BACKGROUNDHyaluronic acid (HA) filler injection is an increasingly popular aesthetic procedure. OBJECTIVETo compare the effectiveness and safety of two HA fillers (HAED and HAPER) for the treatment of severe nasolabial folds (NLFs). MATERIALS AND METHODSThis was an evaluator-blinded and subject-blin...

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Veröffentlicht in:Dermatologic surgery 2017-03, Vol.43 (3), p.389-395
Hauptverfasser: Ascher, Benjamin, Bayerl, Christiane, Kestemont, Philippe, Rzany, Berthold, Edwartz, Carolina, Podda, Maurizio
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container_end_page 395
container_issue 3
container_start_page 389
container_title Dermatologic surgery
container_volume 43
creator Ascher, Benjamin
Bayerl, Christiane
Kestemont, Philippe
Rzany, Berthold
Edwartz, Carolina
Podda, Maurizio
description BACKGROUNDHyaluronic acid (HA) filler injection is an increasingly popular aesthetic procedure. OBJECTIVETo compare the effectiveness and safety of two HA fillers (HAED and HAPER) for the treatment of severe nasolabial folds (NLFs). MATERIALS AND METHODSThis was an evaluator-blinded and subject-blinded split-face study. At baseline, HAED or HAPER was randomly assigned to the left or right NLF. The follow-up period was 12 months. Effectiveness was assessed using the wrinkle severity rating scale (WSRS) and subject preference. Safety was assessed by adverse events and local tolerability symptoms recorded by subjects during 3 weeks after the treatment. RESULTSAt 6 months, HAED was noninferior to HAPER (assessed by mean change from baseline in WSRS score). There was a significant difference in mean WSRS score change from baseline in favor of HAED at 3 to 12 months, and a majority of subjects preferred HAED over HAPER at 12 months. However, the overall responder rate was similar between products, and it remained high throughout the study. At 12 months, approximately 80% of subjects were still responders. Both products were well tolerated and associated with a few treatment-related adverse events. CONCLUSIONTo conclude, HAED was at least as effective and well tolerated for the treatment of severe NLFs as HAPER.
doi_str_mv 10.1097/DSS.0000000000001031
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OBJECTIVETo compare the effectiveness and safety of two HA fillers (HAED and HAPER) for the treatment of severe nasolabial folds (NLFs). MATERIALS AND METHODSThis was an evaluator-blinded and subject-blinded split-face study. At baseline, HAED or HAPER was randomly assigned to the left or right NLF. The follow-up period was 12 months. Effectiveness was assessed using the wrinkle severity rating scale (WSRS) and subject preference. Safety was assessed by adverse events and local tolerability symptoms recorded by subjects during 3 weeks after the treatment. RESULTSAt 6 months, HAED was noninferior to HAPER (assessed by mean change from baseline in WSRS score). There was a significant difference in mean WSRS score change from baseline in favor of HAED at 3 to 12 months, and a majority of subjects preferred HAED over HAPER at 12 months. However, the overall responder rate was similar between products, and it remained high throughout the study. At 12 months, approximately 80% of subjects were still responders. Both products were well tolerated and associated with a few treatment-related adverse events. CONCLUSIONTo conclude, HAED was at least as effective and well tolerated for the treatment of severe NLFs as HAPER.</description><identifier>ISSN: 1076-0512</identifier><identifier>EISSN: 1524-4725</identifier><identifier>DOI: 10.1097/DSS.0000000000001031</identifier><identifier>PMID: 28005623</identifier><language>eng</language><publisher>United States: by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved</publisher><subject>Adult ; Aged ; Double-Blind Method ; Female ; Follow-Up Studies ; France ; Germany ; Humans ; Hyaluronic Acid - administration &amp; dosage ; Injections, Intradermal ; Male ; Middle Aged ; Nasolabial Fold ; Original ; Skin Aging - drug effects ; Sweden ; Treatment Outcome ; Viscosupplements - administration &amp; dosage</subject><ispartof>Dermatologic surgery, 2017-03, Vol.43 (3), p.389-395</ispartof><rights>2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.</rights><rights>2016 The Author(s). 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OBJECTIVETo compare the effectiveness and safety of two HA fillers (HAED and HAPER) for the treatment of severe nasolabial folds (NLFs). MATERIALS AND METHODSThis was an evaluator-blinded and subject-blinded split-face study. At baseline, HAED or HAPER was randomly assigned to the left or right NLF. The follow-up period was 12 months. Effectiveness was assessed using the wrinkle severity rating scale (WSRS) and subject preference. Safety was assessed by adverse events and local tolerability symptoms recorded by subjects during 3 weeks after the treatment. RESULTSAt 6 months, HAED was noninferior to HAPER (assessed by mean change from baseline in WSRS score). There was a significant difference in mean WSRS score change from baseline in favor of HAED at 3 to 12 months, and a majority of subjects preferred HAED over HAPER at 12 months. However, the overall responder rate was similar between products, and it remained high throughout the study. At 12 months, approximately 80% of subjects were still responders. Both products were well tolerated and associated with a few treatment-related adverse events. 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All rights reserved</general><general>Lippincott Williams &amp; Wilkins</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201703</creationdate><title>A 12-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Severe Nasolabial Folds</title><author>Ascher, Benjamin ; Bayerl, Christiane ; Kestemont, Philippe ; Rzany, Berthold ; Edwartz, Carolina ; Podda, Maurizio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4571-af2a2365bf4aa6bf7bf9b35983b9ae977eb0b33a9d7f81855fad2b0c656864a63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>France</topic><topic>Germany</topic><topic>Humans</topic><topic>Hyaluronic Acid - administration &amp; dosage</topic><topic>Injections, Intradermal</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nasolabial Fold</topic><topic>Original</topic><topic>Skin Aging - drug effects</topic><topic>Sweden</topic><topic>Treatment Outcome</topic><topic>Viscosupplements - administration &amp; dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ascher, Benjamin</creatorcontrib><creatorcontrib>Bayerl, Christiane</creatorcontrib><creatorcontrib>Kestemont, Philippe</creatorcontrib><creatorcontrib>Rzany, Berthold</creatorcontrib><creatorcontrib>Edwartz, Carolina</creatorcontrib><creatorcontrib>Podda, Maurizio</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Dermatologic surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ascher, Benjamin</au><au>Bayerl, Christiane</au><au>Kestemont, Philippe</au><au>Rzany, Berthold</au><au>Edwartz, Carolina</au><au>Podda, Maurizio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A 12-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Severe Nasolabial Folds</atitle><jtitle>Dermatologic surgery</jtitle><addtitle>Dermatol Surg</addtitle><date>2017-03</date><risdate>2017</risdate><volume>43</volume><issue>3</issue><spage>389</spage><epage>395</epage><pages>389-395</pages><issn>1076-0512</issn><eissn>1524-4725</eissn><abstract>BACKGROUNDHyaluronic acid (HA) filler injection is an increasingly popular aesthetic procedure. OBJECTIVETo compare the effectiveness and safety of two HA fillers (HAED and HAPER) for the treatment of severe nasolabial folds (NLFs). MATERIALS AND METHODSThis was an evaluator-blinded and subject-blinded split-face study. At baseline, HAED or HAPER was randomly assigned to the left or right NLF. The follow-up period was 12 months. Effectiveness was assessed using the wrinkle severity rating scale (WSRS) and subject preference. Safety was assessed by adverse events and local tolerability symptoms recorded by subjects during 3 weeks after the treatment. RESULTSAt 6 months, HAED was noninferior to HAPER (assessed by mean change from baseline in WSRS score). There was a significant difference in mean WSRS score change from baseline in favor of HAED at 3 to 12 months, and a majority of subjects preferred HAED over HAPER at 12 months. However, the overall responder rate was similar between products, and it remained high throughout the study. 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source Journals@Ovid Ovid Autoload; MEDLINE
subjects Adult
Aged
Double-Blind Method
Female
Follow-Up Studies
France
Germany
Humans
Hyaluronic Acid - administration & dosage
Injections, Intradermal
Male
Middle Aged
Nasolabial Fold
Original
Skin Aging - drug effects
Sweden
Treatment Outcome
Viscosupplements - administration & dosage
title A 12-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Severe Nasolabial Folds
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