A Prospective, Multicenter, Blind, Randomized Controlled, Optimal Clinical Trial to Evaluate the Safety and Efficacy of Medical Collagen Fillers for Facial Dermal Tissue Filling to Correct Frontal Wrinkles (crow's Feet)

With the development of medical technology and the improvement of life treatment,people's concept of aging is also changing, people of all ages are constantly pursuing ayoung and healthy life, the use of lasers and fillers to correct facial wrinkles hasbecome more and more common. For the use of fillers to correct facial wrinkles, theefficacy and safety have been fully established, to the extent that it is a minimallyinvasive treatment, due to its short operation time and rapid recovery, it is considereda very effective treatment for facial wrinkles.Collagen is a kind of natural protein. As the main component of skin tissue, it has theadvantages of good biocompatibility, degradability and low immunogenicity, and is anideal material for correcting facial soft tissue defects. Collagen is implanted under theskin in a non‐surgical way to increase the capacity of the dermis tissue, thus achievingthe purpose of smoothing wrinkles, improving facial defects, and sculpting perfect skin.The medical collagen filling agent of Filaman (Changchun) Pharmaceutical BiotechnologyCo., Ltd. consists of 3.5% bovine collagen It is composed of 0.3% lidocaine hydrochloridesaline suspension, and is filled by injection to repair the shape and correct the contourto achieve satisfactory results. The product is eventually completely degraded in thehuman body, and the expected absorption time is 6‐12 months.In accordance with the requirements of the Medical Device Registration and FilingManagement Measures, the Medical Device Clinical Trial Quality Management Standards, theClinical Trial Registration Review Guidelines for Facial Injection Fillers (Draft forComment), the Clinical Trial Design Guidelines for Medical devices, and the ethicalprinciples of the Declaration of Helsinki of the World Medical Congress, To maximize thebenefit of the subject and avoid as much harm as possible.