VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face
Abstract Background Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume. Objective The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment. Methods Th...
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| Veröffentlicht in: | Aesthetic surgery journal 2020-08, Vol.40 (9), p.499-510 |
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| creator | Ogilvie, Patricia Benouaiche, Laurence Philipp-Dormston, Wolfgang G Belhaouari, Lakhdar Gaymans, Frodo Sattler, Gerhard Harvey, Candice Schumacher, Andrew |
| description | Abstract
Background
Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume.
Objective
The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment.
Methods
This prospective, single-blind, controlled study enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive a single repeat treatment during months 18 to 24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety.
Results
Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15° (0.75°, 1.56°) and 1.16° (0.57°, 1.75°) at month 18, and 3.14° (2.68°, 3.61°) and 2.72° (1.78°, 3.66°) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. The safety profile was as expected.
Conclusions
Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction.
Level of Evidence: 2 |
| doi_str_mv | 10.1093/asj/sjaa013 |
| format | Article |
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Background
Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume.
Objective
The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment.
Methods
This prospective, single-blind, controlled study enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive a single repeat treatment during months 18 to 24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety.
Results
Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15° (0.75°, 1.56°) and 1.16° (0.57°, 1.75°) at month 18, and 3.14° (2.68°, 3.61°) and 2.72° (1.78°, 3.66°) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. The safety profile was as expected.
Conclusions
Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction.
Level of Evidence: 2</description><identifier>ISSN: 1090-820X</identifier><identifier>EISSN: 1527-330X</identifier><identifier>DOI: 10.1093/asj/sjaa013</identifier><identifier>PMID: 31960896</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Cosmetic Medicine ; Cosmetic Techniques - adverse effects ; Face ; Humans ; Hyaluronic Acid - adverse effects ; Patient Satisfaction ; Prospective Studies ; Single-Blind Method ; Skin Aging ; Treatment Outcome</subject><ispartof>Aesthetic surgery journal, 2020-08, Vol.40 (9), p.499-510</ispartof><rights>2020 The Aesthetic Society. 2020</rights><rights>2020 The Aesthetic Society.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c412t-b5b410e1b558ceca520bd74a793ae8d3bd34a36f2ea5d03369de077909d34ed43</citedby><cites>FETCH-LOGICAL-c412t-b5b410e1b558ceca520bd74a793ae8d3bd34a36f2ea5d03369de077909d34ed43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31960896$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ogilvie, Patricia</creatorcontrib><creatorcontrib>Benouaiche, Laurence</creatorcontrib><creatorcontrib>Philipp-Dormston, Wolfgang G</creatorcontrib><creatorcontrib>Belhaouari, Lakhdar</creatorcontrib><creatorcontrib>Gaymans, Frodo</creatorcontrib><creatorcontrib>Sattler, Gerhard</creatorcontrib><creatorcontrib>Harvey, Candice</creatorcontrib><creatorcontrib>Schumacher, Andrew</creatorcontrib><title>VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face</title><title>Aesthetic surgery journal</title><addtitle>Aesthet Surg J</addtitle><description>Abstract
Background
Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume.
Objective
The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment.
Methods
This prospective, single-blind, controlled study enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive a single repeat treatment during months 18 to 24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety.
Results
Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15° (0.75°, 1.56°) and 1.16° (0.57°, 1.75°) at month 18, and 3.14° (2.68°, 3.61°) and 2.72° (1.78°, 3.66°) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. The safety profile was as expected.
Conclusions
Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction.
Level of Evidence: 2</description><subject>Cosmetic Medicine</subject><subject>Cosmetic Techniques - adverse effects</subject><subject>Face</subject><subject>Humans</subject><subject>Hyaluronic Acid - adverse effects</subject><subject>Patient Satisfaction</subject><subject>Prospective Studies</subject><subject>Single-Blind Method</subject><subject>Skin Aging</subject><subject>Treatment Outcome</subject><issn>1090-820X</issn><issn>1527-330X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><sourceid>EIF</sourceid><recordid>eNp9kc1Lw0AQxRdRrFZP3mVPXiR2N5uP5iJI0LYQELQWPYXJ7kRT0mzZTSs9-a-7NVX04mlmeL95A_MIOePsirNEDMDOB3YOwLjYI0c89GNPCPa873qWMG_os-ceObZ2zpjDo-CQ9ARPIjZMoiPyMXtJPT_M6HgD9croppL0RlaKTpo5yhaKGukIazqx9BFKpNAoeluWTqrWSEttaKabV2-KZkEf0LbaQFvp5otLDXaDLulM16sFbrv2Dd3OOxp6BxJPyEEJtcXTXe2Tp7vbaTr2svvRJL3JPBlwv_WKsAg4Q16E4VCihNBnhYoDiBMBOFSiUCIAEZU-QqiYEFGikMVxwhInoApEn1x3vstVsUAlsWkN1PnSVAswm1xDlf9Vmuotf9XrPA78mIeRM7jsDKTR1hosf3Y5y7c55C6HfJeDo89_n_thvx_vgIsO0Kvlv06ftseTUw</recordid><startdate>20200814</startdate><enddate>20200814</enddate><creator>Ogilvie, Patricia</creator><creator>Benouaiche, Laurence</creator><creator>Philipp-Dormston, Wolfgang G</creator><creator>Belhaouari, Lakhdar</creator><creator>Gaymans, Frodo</creator><creator>Sattler, Gerhard</creator><creator>Harvey, Candice</creator><creator>Schumacher, Andrew</creator><general>Oxford University Press</general><scope>TOX</scope><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>5PM</scope></search><sort><creationdate>20200814</creationdate><title>VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face</title><author>Ogilvie, Patricia ; Benouaiche, Laurence ; Philipp-Dormston, Wolfgang G ; Belhaouari, Lakhdar ; Gaymans, Frodo ; Sattler, Gerhard ; Harvey, Candice ; Schumacher, Andrew</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c412t-b5b410e1b558ceca520bd74a793ae8d3bd34a36f2ea5d03369de077909d34ed43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Cosmetic Medicine</topic><topic>Cosmetic Techniques - adverse effects</topic><topic>Face</topic><topic>Humans</topic><topic>Hyaluronic Acid - adverse effects</topic><topic>Patient Satisfaction</topic><topic>Prospective Studies</topic><topic>Single-Blind Method</topic><topic>Skin Aging</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ogilvie, Patricia</creatorcontrib><creatorcontrib>Benouaiche, Laurence</creatorcontrib><creatorcontrib>Philipp-Dormston, Wolfgang G</creatorcontrib><creatorcontrib>Belhaouari, Lakhdar</creatorcontrib><creatorcontrib>Gaymans, Frodo</creatorcontrib><creatorcontrib>Sattler, Gerhard</creatorcontrib><creatorcontrib>Harvey, Candice</creatorcontrib><creatorcontrib>Schumacher, Andrew</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Aesthetic surgery journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ogilvie, Patricia</au><au>Benouaiche, Laurence</au><au>Philipp-Dormston, Wolfgang G</au><au>Belhaouari, Lakhdar</au><au>Gaymans, Frodo</au><au>Sattler, Gerhard</au><au>Harvey, Candice</au><au>Schumacher, Andrew</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face</atitle><jtitle>Aesthetic surgery journal</jtitle><addtitle>Aesthet Surg J</addtitle><date>2020-08-14</date><risdate>2020</risdate><volume>40</volume><issue>9</issue><spage>499</spage><epage>510</epage><pages>499-510</pages><issn>1090-820X</issn><eissn>1527-330X</eissn><abstract>Abstract
Background
Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume.
Objective
The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment.
Methods
This prospective, single-blind, controlled study enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive a single repeat treatment during months 18 to 24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety.
Results
Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15° (0.75°, 1.56°) and 1.16° (0.57°, 1.75°) at month 18, and 3.14° (2.68°, 3.61°) and 2.72° (1.78°, 3.66°) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. The safety profile was as expected.
Conclusions
Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction.
Level of Evidence: 2</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>31960896</pmid><doi>10.1093/asj/sjaa013</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Aesthetic surgery journal, 2020-08, Vol.40 (9), p.499-510 |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Cosmetic Medicine Cosmetic Techniques - adverse effects Face Humans Hyaluronic Acid - adverse effects Patient Satisfaction Prospective Studies Single-Blind Method Skin Aging Treatment Outcome |
| title | VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face |
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