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Clinical Trial of Cross-linked Hyaluronic Acid Dermal Filler

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研究单位: [1]Maxigen Biotech Inc. [2]Beijing Anzhen Hospital, Capital Medical University,Beijing,Chaoyang,China,100029 [3]Beijing Tongren Hospital, Capital Medical University,Beijing,Tongren,China,100005

研究目的:
The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm Young Dermal Filler Injection, which is a hyaluronic acid dermal filler injected into the mid to deep dermis for the correction of moderate-to-severe nasolabial fold facial wrinkles. The main questions it aims to answer are: - The differences of Wrinkle Severity Rating Scale (WSRS) after the injection. - The treatment improvement assessed by Global Aesthetic Improvement Scale (GAIS). - Safety Indicators of which incidences on the day of the injection or after the injection. Participants will be blinded and randomized into either experiment group or control group, and re-visited on 1, 3, 6, 9 and 12 month after injection. Researchers will compare if the test product is non-inferiority to Restylane.

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