Comparison of Two Botulinum Toxin Type A Preparations for Treating Crow's Feet: A Split‐Face, Double‐Blind, Proof‐of‐Concept Study
BACKGROUND This is the first double‐blind, randomized, proof‐of‐concept study to compare the clinical effectiveness of botulinum toxin type A (BoNTA) free of complexing proteins with a BoNTA complex (BTXCo) in the treatment of crow's feet. PATIENTS AND METHOD Twelve U of each product were compa...
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| Veröffentlicht in: | Dermatologic surgery 2010-12, Vol.36 (Supplement 4), p.2155-2160 |
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| container_title | Dermatologic surgery |
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| creator | PRAGER, WELF WISSMÜLLER, ESTHER KOLLHORST, BIANCA WILLIAMS, STEFANIE ZSCHOCKE, INA |
| description | BACKGROUND
This is the first double‐blind, randomized, proof‐of‐concept study to compare the clinical effectiveness of botulinum toxin type A (BoNTA) free of complexing proteins with a BoNTA complex (BTXCo) in the treatment of crow's feet.
PATIENTS AND METHOD
Twelve U of each product were compared in an intra‐individual study in 21 participants with a facial wrinkle scale (FWS) score of 2 to 3. Evaluations were done for up to 4 months. Subjects with an improvement of at least 1 point on the FWS were considered responders.
RESULTS
One month after treatment, the percentage of responders was slightly higher for the BoNTA side (95%) than the BTXCo side (90%). After 4 months, both sides still showed good efficacy, with an 84% response rate and greater than 30% FWS reduction (no statistically significant difference between the products). After 1 month, FWS score at rest was approximately 66% lower for BoNTA, versus 63% lower for BTXCo. After 4 months, FWS reduction was approximately 50%.
CONCLUSION
Both botulinum toxin A products displayed high efficacy and good tolerability at a dose ratio of 1:1, with no statistically significant differences between them. The high response rates observed after 4 months suggest a good effectiveness beyond this observation period.
This study was funded by an unrestricted educational fund from Merz, which also supplied the study medication. |
| doi_str_mv | 10.1111/j.1524-4725.2010.01798.x |
| format | Article |
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This is the first double‐blind, randomized, proof‐of‐concept study to compare the clinical effectiveness of botulinum toxin type A (BoNTA) free of complexing proteins with a BoNTA complex (BTXCo) in the treatment of crow's feet.
PATIENTS AND METHOD
Twelve U of each product were compared in an intra‐individual study in 21 participants with a facial wrinkle scale (FWS) score of 2 to 3. Evaluations were done for up to 4 months. Subjects with an improvement of at least 1 point on the FWS were considered responders.
RESULTS
One month after treatment, the percentage of responders was slightly higher for the BoNTA side (95%) than the BTXCo side (90%). After 4 months, both sides still showed good efficacy, with an 84% response rate and greater than 30% FWS reduction (no statistically significant difference between the products). After 1 month, FWS score at rest was approximately 66% lower for BoNTA, versus 63% lower for BTXCo. After 4 months, FWS reduction was approximately 50%.
CONCLUSION
Both botulinum toxin A products displayed high efficacy and good tolerability at a dose ratio of 1:1, with no statistically significant differences between them. The high response rates observed after 4 months suggest a good effectiveness beyond this observation period.
This study was funded by an unrestricted educational fund from Merz, which also supplied the study medication.</description><identifier>ISSN: 1076-0512</identifier><identifier>EISSN: 1524-4725</identifier><identifier>DOI: 10.1111/j.1524-4725.2010.01798.x</identifier><identifier>PMID: 21134046</identifier><language>eng</language><publisher>Malden, USA: Blackwell Publishing Inc</publisher><subject>Adult ; Botulinum Toxins, Type A - administration & dosage ; Double-Blind Method ; Eye ; Female ; Humans ; Injections ; Male ; Middle Aged ; Neuromuscular Agents - administration & dosage ; Skin Aging - drug effects ; Treatment Outcome</subject><ispartof>Dermatologic surgery, 2010-12, Vol.36 (Supplement 4), p.2155-2160</ispartof><rights>2010 by the American Society for Dermatologic Surgery, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3688-24d28078ec9b7a25b9713060fe6520acd0f56181b816eb77985493242f42800f3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1524-4725.2010.01798.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1524-4725.2010.01798.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21134046$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>PRAGER, WELF</creatorcontrib><creatorcontrib>WISSMÜLLER, ESTHER</creatorcontrib><creatorcontrib>KOLLHORST, BIANCA</creatorcontrib><creatorcontrib>WILLIAMS, STEFANIE</creatorcontrib><creatorcontrib>ZSCHOCKE, INA</creatorcontrib><title>Comparison of Two Botulinum Toxin Type A Preparations for Treating Crow's Feet: A Split‐Face, Double‐Blind, Proof‐of‐Concept Study</title><title>Dermatologic surgery</title><addtitle>Dermatol Surg</addtitle><description>BACKGROUND
This is the first double‐blind, randomized, proof‐of‐concept study to compare the clinical effectiveness of botulinum toxin type A (BoNTA) free of complexing proteins with a BoNTA complex (BTXCo) in the treatment of crow's feet.
PATIENTS AND METHOD
Twelve U of each product were compared in an intra‐individual study in 21 participants with a facial wrinkle scale (FWS) score of 2 to 3. Evaluations were done for up to 4 months. Subjects with an improvement of at least 1 point on the FWS were considered responders.
RESULTS
One month after treatment, the percentage of responders was slightly higher for the BoNTA side (95%) than the BTXCo side (90%). After 4 months, both sides still showed good efficacy, with an 84% response rate and greater than 30% FWS reduction (no statistically significant difference between the products). After 1 month, FWS score at rest was approximately 66% lower for BoNTA, versus 63% lower for BTXCo. After 4 months, FWS reduction was approximately 50%.
CONCLUSION
Both botulinum toxin A products displayed high efficacy and good tolerability at a dose ratio of 1:1, with no statistically significant differences between them. The high response rates observed after 4 months suggest a good effectiveness beyond this observation period.
This study was funded by an unrestricted educational fund from Merz, which also supplied the study medication.</description><subject>Adult</subject><subject>Botulinum Toxins, Type A - administration & dosage</subject><subject>Double-Blind Method</subject><subject>Eye</subject><subject>Female</subject><subject>Humans</subject><subject>Injections</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neuromuscular Agents - administration & dosage</subject><subject>Skin Aging - drug effects</subject><subject>Treatment Outcome</subject><issn>1076-0512</issn><issn>1524-4725</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNUc1O3DAYtCpQobSvUPnGhSyfHSdxkDhA6BYkJJA2nK38fK6ySuJgJ9rdW8899Rn7JHVY4IwP9jf2zFiaIYQyWDC_ztcLFnERiIRHCw7-FliSysX2Ezl-fzjwMyRxABHjR-SLc2sAxtMQPpMjzlgoQMTH5E9muqGwjTM9NZrmG0OvzTi1TT91NDfbpqf5bkB6RR8temIxNqZ3VBtLc4se9b9oZs3m1NEl4njhiauhbcZ_v_8uiwrP6I2ZyhY9vPae9Zm3MUZ7-LJlpq9wGOlqnOrdV3Koi9bht9fzhDwtf-TZbXD_8PMuu7oPqjCWMuCi5hISiVVaJgWPyjRhIcSgMY44FFUNOoqZZKVkMZaJzyUSacgF18LrQIcn5HTvO1jzPKEbVde4Ctu26NFMTkmRAqRJHHqm3DMra5yzqNVgm66wO8VAzUWotZrzVnPeai5CvRShtl76_fWTqeywfhe-Je8Jl3vCpmlx92FjdbN6mqfwPwYymZA</recordid><startdate>201012</startdate><enddate>201012</enddate><creator>PRAGER, WELF</creator><creator>WISSMÜLLER, ESTHER</creator><creator>KOLLHORST, BIANCA</creator><creator>WILLIAMS, STEFANIE</creator><creator>ZSCHOCKE, INA</creator><general>Blackwell Publishing Inc</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>201012</creationdate><title>Comparison of Two Botulinum Toxin Type A Preparations for Treating Crow's Feet: A Split‐Face, Double‐Blind, Proof‐of‐Concept Study</title><author>PRAGER, WELF ; WISSMÜLLER, ESTHER ; KOLLHORST, BIANCA ; WILLIAMS, STEFANIE ; ZSCHOCKE, INA</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3688-24d28078ec9b7a25b9713060fe6520acd0f56181b816eb77985493242f42800f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Botulinum Toxins, Type A - administration & dosage</topic><topic>Double-Blind Method</topic><topic>Eye</topic><topic>Female</topic><topic>Humans</topic><topic>Injections</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neuromuscular Agents - administration & dosage</topic><topic>Skin Aging - drug effects</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>PRAGER, WELF</creatorcontrib><creatorcontrib>WISSMÜLLER, ESTHER</creatorcontrib><creatorcontrib>KOLLHORST, BIANCA</creatorcontrib><creatorcontrib>WILLIAMS, STEFANIE</creatorcontrib><creatorcontrib>ZSCHOCKE, INA</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>PRAGER, WELF</au><au>WISSMÜLLER, ESTHER</au><au>KOLLHORST, BIANCA</au><au>WILLIAMS, STEFANIE</au><au>ZSCHOCKE, INA</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of Two Botulinum Toxin Type A Preparations for Treating Crow's Feet: A Split‐Face, Double‐Blind, Proof‐of‐Concept Study</atitle><jtitle>Dermatologic surgery</jtitle><addtitle>Dermatol Surg</addtitle><date>2010-12</date><risdate>2010</risdate><volume>36</volume><issue>Supplement 4</issue><spage>2155</spage><epage>2160</epage><pages>2155-2160</pages><issn>1076-0512</issn><eissn>1524-4725</eissn><abstract>BACKGROUND
This is the first double‐blind, randomized, proof‐of‐concept study to compare the clinical effectiveness of botulinum toxin type A (BoNTA) free of complexing proteins with a BoNTA complex (BTXCo) in the treatment of crow's feet.
PATIENTS AND METHOD
Twelve U of each product were compared in an intra‐individual study in 21 participants with a facial wrinkle scale (FWS) score of 2 to 3. Evaluations were done for up to 4 months. Subjects with an improvement of at least 1 point on the FWS were considered responders.
RESULTS
One month after treatment, the percentage of responders was slightly higher for the BoNTA side (95%) than the BTXCo side (90%). After 4 months, both sides still showed good efficacy, with an 84% response rate and greater than 30% FWS reduction (no statistically significant difference between the products). After 1 month, FWS score at rest was approximately 66% lower for BoNTA, versus 63% lower for BTXCo. After 4 months, FWS reduction was approximately 50%.
CONCLUSION
Both botulinum toxin A products displayed high efficacy and good tolerability at a dose ratio of 1:1, with no statistically significant differences between them. The high response rates observed after 4 months suggest a good effectiveness beyond this observation period.
This study was funded by an unrestricted educational fund from Merz, which also supplied the study medication.</abstract><cop>Malden, USA</cop><pub>Blackwell Publishing Inc</pub><pmid>21134046</pmid><doi>10.1111/j.1524-4725.2010.01798.x</doi><tpages>6</tpages></addata></record> |
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| source | Wiley Online Library - AutoHoldings Journals; MEDLINE; Journals@Ovid Complete |
| subjects | Adult Botulinum Toxins, Type A - administration & dosage Double-Blind Method Eye Female Humans Injections Male Middle Aged Neuromuscular Agents - administration & dosage Skin Aging - drug effects Treatment Outcome |
| title | Comparison of Two Botulinum Toxin Type A Preparations for Treating Crow's Feet: A Split‐Face, Double‐Blind, Proof‐of‐Concept Study |
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