Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel
BACKGROUNDVYC-25L, a hyaluronic acid soft-tissue filler with lidocaine, is designed to restore and create facial volume in the chin and jaw. OBJECTIVETo evaluate the safety and effectiveness of VYC-25L in subjects with chin retrusion. METHODSAdults with chin retrusion (145°–165° glabella–subnasale–p...
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| Veröffentlicht in: | Dermatologic surgery 2019-10, Vol.45 (10), p.1294-1303 |
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| container_title | Dermatologic surgery |
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| creator | Ogilvie, Patricia Sattler, Gerhard Gaymans, Frodo Belhaouari, Lakhdar Weichman, Barry M Snow, Sean Chawla, Smita Abrams, Steve Schumacher, Andrew |
| description | BACKGROUNDVYC-25L, a hyaluronic acid soft-tissue filler with lidocaine, is designed to restore and create facial volume in the chin and jaw.
OBJECTIVETo evaluate the safety and effectiveness of VYC-25L in subjects with chin retrusion.
METHODSAdults with chin retrusion (145°–165° glabella–subnasale–pogonion facial angle) were randomized (3:1) to receive VYC-25L in the chin/jaw at study onset (treatment group) or 3 months later (control group). Primary effectiveness end point was mean change in facial angle from baseline at Month 3. Safety assessments included injection site responses (ISRs), recorded in a subject diary, and adverse events (AEs).
RESULTSVYC-25L was administered to 119 subjects (treatment groupn = 90; control groupn = 29). Mean change in facial angle from baseline at Month 3 was significantly greater in the treatment versus control group (difference2.51°; p < .0001). Effectiveness was also demonstrated by the proportion of subjects with improved/much improved Global Aesthetic Improvement Scale scores and responses on FACE-Q Satisfaction and Psychological Well-Being Scales. Treatment benefit remained evident at Month 12. Common ISRs were firmness (95.8%), tenderness (95.8%), and swelling (91.6%). No serious treatment-related AEs were reported.
CONCLUSIONVYC-25L significantly improved glabella–subnasale–pogonion facial angle and was generally safe and well tolerated. |
| doi_str_mv | 10.1097/DSS.0000000000001960 |
| format | Article |
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OBJECTIVETo evaluate the safety and effectiveness of VYC-25L in subjects with chin retrusion.
METHODSAdults with chin retrusion (145°–165° glabella–subnasale–pogonion facial angle) were randomized (3:1) to receive VYC-25L in the chin/jaw at study onset (treatment group) or 3 months later (control group). Primary effectiveness end point was mean change in facial angle from baseline at Month 3. Safety assessments included injection site responses (ISRs), recorded in a subject diary, and adverse events (AEs).
RESULTSVYC-25L was administered to 119 subjects (treatment groupn = 90; control groupn = 29). Mean change in facial angle from baseline at Month 3 was significantly greater in the treatment versus control group (difference2.51°; p < .0001). Effectiveness was also demonstrated by the proportion of subjects with improved/much improved Global Aesthetic Improvement Scale scores and responses on FACE-Q Satisfaction and Psychological Well-Being Scales. Treatment benefit remained evident at Month 12. Common ISRs were firmness (95.8%), tenderness (95.8%), and swelling (91.6%). No serious treatment-related AEs were reported.
CONCLUSIONVYC-25L significantly improved glabella–subnasale–pogonion facial angle and was generally safe and well tolerated.</description><identifier>ISSN: 1076-0512</identifier><identifier>EISSN: 1524-4725</identifier><identifier>DOI: 10.1097/DSS.0000000000001960</identifier><identifier>PMID: 31135570</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 ; Chin ; Cosmetic Techniques - adverse effects ; Dermal Fillers - administration & dosage ; Dermal Fillers - adverse effects ; Drug Combinations ; Esthetics ; Female ; Humans ; Hyaluronic Acid - administration & dosage ; Hyaluronic Acid - adverse effects ; Injection Site Reaction - epidemiology ; Jaw ; Lidocaine - administration & dosage ; Lidocaine - adverse effects ; Male ; Middle Aged ; Patient Satisfaction ; Skin Aging - drug effects ; Treatment Outcome ; Young Adult</subject><ispartof>Dermatologic surgery, 2019-10, Vol.45 (10), p.1294-1303</ispartof><rights>2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4070-685be8c962816a974abb563d29bcef1181dc5005d1c013be0f702369238730ba3</citedby><cites>FETCH-LOGICAL-c4070-685be8c962816a974abb563d29bcef1181dc5005d1c013be0f702369238730ba3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31135570$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ogilvie, Patricia</creatorcontrib><creatorcontrib>Sattler, Gerhard</creatorcontrib><creatorcontrib>Gaymans, Frodo</creatorcontrib><creatorcontrib>Belhaouari, Lakhdar</creatorcontrib><creatorcontrib>Weichman, Barry M</creatorcontrib><creatorcontrib>Snow, Sean</creatorcontrib><creatorcontrib>Chawla, Smita</creatorcontrib><creatorcontrib>Abrams, Steve</creatorcontrib><creatorcontrib>Schumacher, Andrew</creatorcontrib><title>Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel</title><title>Dermatologic surgery</title><addtitle>Dermatol Surg</addtitle><description>BACKGROUNDVYC-25L, a hyaluronic acid soft-tissue filler with lidocaine, is designed to restore and create facial volume in the chin and jaw.
OBJECTIVETo evaluate the safety and effectiveness of VYC-25L in subjects with chin retrusion.
METHODSAdults with chin retrusion (145°–165° glabella–subnasale–pogonion facial angle) were randomized (3:1) to receive VYC-25L in the chin/jaw at study onset (treatment group) or 3 months later (control group). Primary effectiveness end point was mean change in facial angle from baseline at Month 3. Safety assessments included injection site responses (ISRs), recorded in a subject diary, and adverse events (AEs).
RESULTSVYC-25L was administered to 119 subjects (treatment groupn = 90; control groupn = 29). Mean change in facial angle from baseline at Month 3 was significantly greater in the treatment versus control group (difference2.51°; p < .0001). Effectiveness was also demonstrated by the proportion of subjects with improved/much improved Global Aesthetic Improvement Scale scores and responses on FACE-Q Satisfaction and Psychological Well-Being Scales. Treatment benefit remained evident at Month 12. Common ISRs were firmness (95.8%), tenderness (95.8%), and swelling (91.6%). No serious treatment-related AEs were reported.
CONCLUSIONVYC-25L significantly improved glabella–subnasale–pogonion facial angle and was generally safe and well tolerated.</description><subject>Adult</subject><subject>Aged</subject><subject>Chin</subject><subject>Cosmetic Techniques - adverse effects</subject><subject>Dermal Fillers - administration & dosage</subject><subject>Dermal Fillers - adverse effects</subject><subject>Drug Combinations</subject><subject>Esthetics</subject><subject>Female</subject><subject>Humans</subject><subject>Hyaluronic Acid - administration & dosage</subject><subject>Hyaluronic Acid - adverse effects</subject><subject>Injection Site Reaction - epidemiology</subject><subject>Jaw</subject><subject>Lidocaine - administration & dosage</subject><subject>Lidocaine - adverse effects</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Patient Satisfaction</subject><subject>Skin Aging - drug effects</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1076-0512</issn><issn>1524-4725</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE1PwkAQhjdGI4r-A2P26MHi7G63H0eCCBgSE0GNp2a7nYbi0uJuK-HfWwMa48G5zByed2byEHLBoMcgDm9uZ7Me_CoWB3BATpjkvueHXB62M4SBB5LxDjl1btkyPBZwTDqCMSFlCCdkPlM5XtNhnqOuiw-kg0VRUlVm9F5t6CO6urKqLqqSvhT1gj6_Djwup3S8VaaxVVlo2tdFRiflss2r1CAdoTkjR7kyDs_3vUue7obzwdibPowmg_7U0z6E4AWRTDHSccAjFqg49FWaykBkPE415oxFLNMSQGZMAxMpQh4CF0HMRRQKSJXokqvd3rWt3pv212RVOI3GqBKrxiWcC87Al75oUX-Hals5ZzFP1rZYKbtNGCRfPpPWZ_LXZxu73F9o0hVmP6FvgS0Q7YBNZWq07s00G7TJApWpF__v_gRwin5F</recordid><startdate>201910</startdate><enddate>201910</enddate><creator>Ogilvie, Patricia</creator><creator>Sattler, Gerhard</creator><creator>Gaymans, Frodo</creator><creator>Belhaouari, Lakhdar</creator><creator>Weichman, Barry M</creator><creator>Snow, Sean</creator><creator>Chawla, Smita</creator><creator>Abrams, Steve</creator><creator>Schumacher, Andrew</creator><general>by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved</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></search><sort><creationdate>201910</creationdate><title>Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel</title><author>Ogilvie, Patricia ; Sattler, Gerhard ; Gaymans, Frodo ; Belhaouari, Lakhdar ; Weichman, Barry M ; Snow, Sean ; Chawla, Smita ; Abrams, Steve ; Schumacher, Andrew</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4070-685be8c962816a974abb563d29bcef1181dc5005d1c013be0f702369238730ba3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Chin</topic><topic>Cosmetic Techniques - adverse effects</topic><topic>Dermal Fillers - administration & dosage</topic><topic>Dermal Fillers - adverse effects</topic><topic>Drug Combinations</topic><topic>Esthetics</topic><topic>Female</topic><topic>Humans</topic><topic>Hyaluronic Acid - administration & dosage</topic><topic>Hyaluronic Acid - adverse effects</topic><topic>Injection Site Reaction - epidemiology</topic><topic>Jaw</topic><topic>Lidocaine - administration & dosage</topic><topic>Lidocaine - adverse effects</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Patient Satisfaction</topic><topic>Skin Aging - drug effects</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ogilvie, Patricia</creatorcontrib><creatorcontrib>Sattler, Gerhard</creatorcontrib><creatorcontrib>Gaymans, Frodo</creatorcontrib><creatorcontrib>Belhaouari, Lakhdar</creatorcontrib><creatorcontrib>Weichman, Barry M</creatorcontrib><creatorcontrib>Snow, Sean</creatorcontrib><creatorcontrib>Chawla, Smita</creatorcontrib><creatorcontrib>Abrams, Steve</creatorcontrib><creatorcontrib>Schumacher, Andrew</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><jtitle>Dermatologic surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ogilvie, Patricia</au><au>Sattler, Gerhard</au><au>Gaymans, Frodo</au><au>Belhaouari, Lakhdar</au><au>Weichman, Barry M</au><au>Snow, Sean</au><au>Chawla, Smita</au><au>Abrams, Steve</au><au>Schumacher, Andrew</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel</atitle><jtitle>Dermatologic surgery</jtitle><addtitle>Dermatol Surg</addtitle><date>2019-10</date><risdate>2019</risdate><volume>45</volume><issue>10</issue><spage>1294</spage><epage>1303</epage><pages>1294-1303</pages><issn>1076-0512</issn><eissn>1524-4725</eissn><abstract>BACKGROUNDVYC-25L, a hyaluronic acid soft-tissue filler with lidocaine, is designed to restore and create facial volume in the chin and jaw.
OBJECTIVETo evaluate the safety and effectiveness of VYC-25L in subjects with chin retrusion.
METHODSAdults with chin retrusion (145°–165° glabella–subnasale–pogonion facial angle) were randomized (3:1) to receive VYC-25L in the chin/jaw at study onset (treatment group) or 3 months later (control group). Primary effectiveness end point was mean change in facial angle from baseline at Month 3. Safety assessments included injection site responses (ISRs), recorded in a subject diary, and adverse events (AEs).
RESULTSVYC-25L was administered to 119 subjects (treatment groupn = 90; control groupn = 29). Mean change in facial angle from baseline at Month 3 was significantly greater in the treatment versus control group (difference2.51°; p < .0001). Effectiveness was also demonstrated by the proportion of subjects with improved/much improved Global Aesthetic Improvement Scale scores and responses on FACE-Q Satisfaction and Psychological Well-Being Scales. Treatment benefit remained evident at Month 12. Common ISRs were firmness (95.8%), tenderness (95.8%), and swelling (91.6%). No serious treatment-related AEs were reported.
CONCLUSIONVYC-25L significantly improved glabella–subnasale–pogonion facial angle and was generally safe and well tolerated.</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>31135570</pmid><doi>10.1097/DSS.0000000000001960</doi><tpages>10</tpages></addata></record> |
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| subjects | Adult Aged Chin Cosmetic Techniques - adverse effects Dermal Fillers - administration & dosage Dermal Fillers - adverse effects Drug Combinations Esthetics Female Humans Hyaluronic Acid - administration & dosage Hyaluronic Acid - adverse effects Injection Site Reaction - epidemiology Jaw Lidocaine - administration & dosage Lidocaine - adverse effects Male Middle Aged Patient Satisfaction Skin Aging - drug effects Treatment Outcome Young Adult |
| title | Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel |
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