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 |
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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 & dosage ; Injections, Intradermal ; Male ; Middle Aged ; Nasolabial Fold ; Original ; Skin Aging - drug effects ; Sweden ; Treatment Outcome ; Viscosupplements - administration & 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). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc. 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4571-af2a2365bf4aa6bf7bf9b35983b9ae977eb0b33a9d7f81855fad2b0c656864a63</citedby><cites>FETCH-LOGICAL-c4571-af2a2365bf4aa6bf7bf9b35983b9ae977eb0b33a9d7f81855fad2b0c656864a63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28005623$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ascher, Benjamin</creatorcontrib><creatorcontrib>Bayerl, Christiane</creatorcontrib><creatorcontrib>Kestemont, Philippe</creatorcontrib><creatorcontrib>Rzany, Berthold</creatorcontrib><creatorcontrib>Edwartz, Carolina</creatorcontrib><creatorcontrib>Podda, Maurizio</creatorcontrib><title>A 12-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Severe Nasolabial Folds</title><title>Dermatologic surgery</title><addtitle>Dermatol Surg</addtitle><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.</description><subject>Adult</subject><subject>Aged</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>France</subject><subject>Germany</subject><subject>Humans</subject><subject>Hyaluronic Acid - administration & dosage</subject><subject>Injections, Intradermal</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nasolabial Fold</subject><subject>Original</subject><subject>Skin Aging - drug effects</subject><subject>Sweden</subject><subject>Treatment Outcome</subject><subject>Viscosupplements - administration & dosage</subject><issn>1076-0512</issn><issn>1524-4725</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kcGO0zAQhiMEYpeFN0DIRw5ksZ04Ti5IVdmySAtItJytcTKmBicudtKqvASvjKMuq4UDc_FI883_j_xn2XNGLxlt5Ou36_UlvVeMFuxBds4EL_NScvEw9VRWORWMn2VPYvyWGN4U9HF2xmtKRcWL8-zXgjCef_DDuCUr75w_5NPuFfkMQ-d7-xM7svT9DoKNfiDekCtjsB3tHgeMkSSKrMHgeJxnm4Mn10dwU_CDbcmitR1ZWecwRGJ8IJuAMPY4jDO8xj0GJB8hegfagpvtu_g0e2TARXx2-15kX1ZXm-V1fvPp3fvl4iZvSyFZDoYDLyqhTQlQaSO1aXQhmrrQDWAjJWqqiwKaTpqa1UIY6LimbSWquiqhKi6yNyfd3aR77Np0VQCndsH2EI7Kg1V_Twa7VV_9XomSlZKJJPDyViD4HxPGUfU2tugcDOinqJIpl7IRckbLE9oGH2NAc2fDqJqzVClL9W-Wae3F_RPvlv6El4D6BBy8G9Mnf3fTAYPaIrhx-3_t33AyrWI</recordid><startdate>201703</startdate><enddate>201703</enddate><creator>Ascher, Benjamin</creator><creator>Bayerl, Christiane</creator><creator>Kestemont, Philippe</creator><creator>Rzany, Berthold</creator><creator>Edwartz, Carolina</creator><creator>Podda, Maurizio</creator><general>by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved</general><general>Lippincott Williams & 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 & 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 & 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. 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.</abstract><cop>United States</cop><pub>by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved</pub><pmid>28005623</pmid><doi>10.1097/DSS.0000000000001031</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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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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