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A Randomized, Controlled Study To Evaluate The Efficacy And Safety Of Revanesse? Ultra For The Correction Of Nasolabial Folds

Posted on:2013-10-25Degree:MasterType:Thesis
Country:ChinaCandidate:Y W ZhangFull Text:PDF
GTID:2234330374466290Subject:Surgery
Abstract/Summary:PDF Full Text Request
Objective: To evaluate the efficacy and safety of Revanesse Ultraversus Restylane for the correction of moderate to severenasolabial folds (NLF) in a Chinese population.Methods:120Subjects with moderate to severe nasolabial folds(Wrinkle Severity Rating Scale, WSRS) were divided into twogroups randomly. The Subjects received Revanesse Ultra injectionin experimental group, and Restylane in control group.Wrinkleimprovement was measured before and after injection1,3and6months, using the Wrinkle Severity Rating Scale (WSRS) and theGlobal Aesthetic Improvement Scale (GAIS) as outcome criteria.Local tolerability was assessed based on subject diary dur ing thefrst2weeks after injection. Adverse events were also evaluated.Results:120subjects (96%female, average age44years) weretreated. Both products showed immediate, good results afterinjection and demonstrated good durability over time. Respon derrate on WSRS at Month6were93.2%in experimental group and89.8%in control group. The effectiveness of Revanesse Ultra andRestylane was not statistically different (P>0.05). Both productswere well tolerated, without serious adverse events.Conclusion: The effect for the correction of nasolabial folds afterinjection of Revanesse Ultra and Restylane is generallycomparable in a Chinese population. They are safe and tolerated....
Keywords/Search Tags:nasolabial folds, hyaluronic acid, effcacy, safety
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