I-FDA igunyaze i-Restylane Defyne yokukhulisa umhlathi

UGalderma umemezele ukuthi i-FDA igunyaze i-Restylane Defyne, i-HA dermal filler, yokukhulisa isilevu.
Inkampani yobuhle nethaka imithi i-Galderma isanda kumemezela ukuthi i-FDA igunyaze i-Restylane Defyne ukuze kuthuthukiswe futhi kulungiswe ukuwohloka kwesilevu okumaphakathi kuya kokumaphakathi kubantu abadala abangaphezulu kweminyaka engama-21 ubudala.
I-Restylane Defyne, eyamukelwa okokuqala ngo-2016, iyi-hyaluronic acid (HA) dermal filler ekuqaleni eyayisetshenziselwa umjovo ophakathi kuya ojulile ezicutshini zobuso ukwelapha imibimbi yobuso nokugoqeka okumaphakathi kuya kokuqina.
I-Galderma isebenzisa inqubo yayo eyingqayizivele yokukhiqiza ubuchwepheshe be-XpresHAN, eyaziwa emhlabeni wonke ngokuthi i-Optimal Balance Technology (OBT), ukuze yenze ijeli ejovayo ebushelelezi ekwazi ukuhlangana kalula esikhumbeni ukuze inyakaze ngokwemvelo nokushintshashintshayo.
"Lokhu kuphawula isikhathi sesi-8 lapho uGalderma ethola imvume yobuhle ye-FDA eminyakeni emi-5, futhi kukhombisa ukuthi sizibophezele isikhathi eside ukukhuthaza ubuhle ngokusebenzisa izinto ezintsha," kusho u-Alisa Lask, umphathi jikelele kanye nephini likamongameli webhizinisi le-aesthetics laseMelika likaGalderma, kusho u-Alisa Lask. ekukhululweni kwabezindaba ememezela ukugunyazwa.“Isilevu siyisisekelo sobuso futhi singakwazi ukulinganisa ezinye izici zakho.Abathengi manje bangasebenzisa izinketho ezingahlinzeki, eziphephile ukuxazulula izinkinga zesilevu.Lo mkhiqizo usebenzisa ubuchwepheshe be-XpresHAN obusezingeni eliphezulu ukuze ulolonge futhi ukhiqize imiphumela ehlala isikhathi eside.”
Ukugunyazwa kwe-Restylane Defyne kutholwe ngemva kwedatha evela ocwaningweni olubalulekile lweSigaba sesi-3 somtholampilo esisekela ukuphepha nokubekezelelana kwayo ekwandiseni umhlathi.Ezigulini ocwaningweni, i-86% ayizange ihlangabezane nezenzakalo ezimbi ezihlobene nokwelashwa, futhi isenzakalo esisodwa kuphela esilinganiselwe sobuhlungu besayithi lomjovo.
Amaphesenti angamashumi ayisishiyagalolunye nesishiyagalolunye eziguli abike ukuthuthuka ekubukekeni kwesilevu esiphumile (lapho sibuzwa emasontweni ayi-12), kanti ama-96% ama-injection athi ukwelashwa kuthuthukisa ukubukeka kwesilevu esiphumile isikhathi esingangonyaka.
Uhlolo lubonise ukuthi u-74% weziguli ube nokuthuthuka okuphawulekayo ekubukeni kwesilevu esikhathini esingafika onyakeni owodwa, uma kuqhathaniswa nama-86% emasontweni ayi-12.Lokhu kukalwa kusetshenziswa i-Gartner's Chin Retraction Scale (GCRS).Imiphumela yobuhle ngemva kokwelashwa yayimihle futhi yaboniswa izinga eliphezulu lokwaneliseka kwesifundo kuhlu lwemibuzo lwe-FACE-Q kanye ne-Global Aesthetic Improvement Scale (GAIS).
“Iziguli zami zivame ukuza kimi zizobuza ngezindlela ezintsha zokwelapha ukuze ziqhubeke nokugcina isimo sazo esihle kakhulu.Abantu abaningi bayamangala lapho ngichaza umphumela womhlathi owandisiwe kanye nokulingana kobuso obuphansi kuyisihluthulelo sokusiza ekufinyeleleni ukukhanga okuphelele kobuso, "u-Anne Chapas, MD, udokotela wesikhumba oqinisekisiwe webhodi kanye nodokotela wesikhumba eNew York, kanye nomphenyi wezifo zesikhumba. Ukuhlolwa komtholampilo kwe-Restylane Defyne Chin, kusho esitatimendeni sabezindaba."Ingxenye engezansi yobuso ihlala inyakaza, ngakho-ke kubalulekile ukuthi iziguli zikhethe ama-filler ashukumisayo njenge-Restylane Defyne, athuthukiswe ngokwesayensi ukuze avumelane nesimo sobuso bazo."