Galderma o phatlalalitse hore FDA e amohetse Restylane Defyne, e leng HA dermal filler, bakeng sa ho holisa selelu.
Khampani ea botle le ea meriana Galderma haufinyane e phatlalalitse hore FDA e amohetse Restylane Defyne bakeng sa ntlafatso le tokiso ea ho theoha ha selelu ho ea ho batho ba baholo ho feta lilemo tse 21.
Restylane Defyne, e amohetsoeng ka lekhetlo la pele ka 2016, ke hyaluronic acid (HA) dermal filler qalong e neng e sebelisoa bakeng sa ente e tebileng ho isa lipakeng tsa lisele tsa sefahleho ho alafa mats'ope a sefahleho a itekanetseng ho isa ho a matla.
Galderma e sebelisa mokhoa oa eona o ikhethang oa ho etsa theknoloji ea XpresHAN, e tsejoang lefatšeng ka bophara e le Optimal Balance Technology (OBT), ho etsa gel e nang le ente e boreleli e ka kenang habonolo letlalong bakeng sa motsamao oa tlhaho le o matla.
"Sena se tšoaea lekhetlo la 8 ha Galderma a fumana tumello ea FDA ea botle ka lilemo tse 5, 'me e bontša hore re na le boitlamo ba nako e telele ba ho ntšetsa pele botle ba botle ka mekhoa e mecha," ho boletse Alisa Lask, mookameli oa kakaretso le motlatsi oa mopresidente oa khoebo ea Galderma's American aesthetics. phatlalatsong ea phatlalatso e phatlalatsang tumello.“Seledu ke motheo oa sefahleho ’me se ka leka-lekanya litšobotsi tse ling tsa hao.Bareki joale ba ka sebelisa mekhoa e sa buuoeng, e sireletsehileng ho rarolla mathata a selelu.Letšoao lena le sebelisa theknoloji ea morao-rao ea XpresHAN ho theha le ho hlahisa litholoana tse tšoarellang nako e telele. ”
Tumello ea Restylane Defyne e ile ea fumanoa ka mor'a lintlha tse tsoang tekong ea bohlokoa ea Phase 3 e tšehetsang polokeho le mamello ea eona ho holisa mohlahare.Ho bakuli ba thuto, 86% ha ea ka ea e-ba le liketsahalo tse mpe tse amanang le phekolo, 'me ke ketsahalo e le' ngoe feela e itekanetseng ea bohloko ba sebaka sa ente.
Liperesente tse mashome a robong a metso e robong tsa bakuli li tlalehile ntlafatso ponahalong ea selelu se hlahelletseng (ha se botsoa libeke tse 12), mme 96% ea liente e boletse hore kalafo e ntlafalitse ponahalo ea selelu se hlahelletseng ho fihlela selemo.
Teko e bonts'itse hore 74% ea bakuli e bile le ntlafatso e kholo holima selelu nakong ea selemo se le seng, ha ho bapisoa le 86% libekeng tse 12.Sena se lekanyetsoa ho sebelisoa Gartner's Chin Retraction Scale (GCRS).Liphello tse ntle ka mor'a phekolo li ne li le ntle 'me li ile tsa bontšoa ke boemo bo phahameng ba khotsofalo ea thuto ho FACE-Q le Global Aesthetic Improvement Scale (GAIS) lipotso.
"Bakuli ba ka ba atisa ho tla ho 'na ho tla mpotsa ka mekhoa e mecha ea phekolo e le hore ba tsoele pele ho boloka boemo ba bona bo botle.Batho ba bangata baa makala ha ke hlalosa phello ea mohlahare o atolositsoeng le ho leka-lekana ha sefahleho se ka tlaase ke senotlolo sa ho thusa ho finyella botle bo feletseng ba sefahleho, "Anne Chapas, MD, setsebi sa dermatologist se tiisitsoeng ka boto le dermatologist New York, le mofuputsi oa Teko ea kliniki ea Restylane Defyne Chin, e boletse phatlalatsong ea litaba."Karolo e ka tlaase ea sefahleho e lula e tsamaea, kahoo ke habohlokoa hore bakuli ba khethe li-filler tse matla tse kang Restylane Defyne, tse entsoeng ka saense ho ikamahanya le ponahalo ea sefahleho sa bona."
Nako ea poso: Jul-22-2021