A Phase 3 interventional study of Crow's feet injection filling and Humanized collagen filling crow's feet in Intentional Correction of Forehead Wrinkles (crow's Feet), sponsored by Fiman (Changchun) Pharmaceutical Biotechnology Company Limited. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Fiman (Changchun) Pharmaceutical Biotechnology Company Limited · Phase 3, Interventional, and Treatment
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 a young and healthy life, the use of lasers and fillers to correct facial wrinkles has become more and more common. For the use of fillers to correct facial wrinkles, the efficacy and safety have been fully established, to the extent that it is a minimally invasive treatment, due to its short operation time and rapid recovery, it is considered a very effective treatment for facial wrinkles.
Collagen is a kind of natural protein. As the main component of skin tissue, it has the advantages of good biocompatibility, degradability and low immunogenicity, and is an ideal material for correcting facial soft tissue defects. Collagen is implanted under the skin in a non-surgical way to increase the capacity of the dermis tissue, thus achieving the purpose of smoothing wrinkles, improving facial defects, and sculpting perfect skin. The medical collagen filling agent of Filaman (Changchun) Pharmaceutical Biotechnology Co., Ltd. consists of 3.5% bovine collagen It is composed of 0.3% lidocaine hydrochloride saline suspension, and is filled by injection to repair the shape and correct the contour to achieve satisfactory results. The product is eventually completely degraded in the human body, and the expected absorption time is 6-12 months.
In accordance with the requirements of the Medical Device Registration and Filing Management Measures, the Medical Device Clinical Trial Quality Management Standards, the Clinical Trial Registration Review Guidelines for Facial Injection Fillers (Draft for Comment), the Clinical Trial Design Guidelines for Medical devices, and the ethical principles of the Declaration of Helsinki of the World Medical Congress, To maximize the benefit of the subject and avoid as much harm as possible.
This is the only study on the registry with Fiman (Changchun) Pharmaceutical Biotechnology Company Limited as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Facial area of calcium hydroxyapatite (CaHA), poly-L-lactic acid (PLLA) or plastic therapy
Domain therapy, or subjects who plan to receive such therapy during study participation;
Bovine collagen filling crow's feet
Procedure: Crow's feet injection filling · Procedure: Humanized collagen filling crow's feet
Patients with crow's feet of different degree were randomly divided into two groups, which were injected with bovine collagen and humanized collagen respectively
Bovine collagen filling crow's feet
Blind investigators graded the severity of wrinkles at 1 month, 6 months, and 12 months after the last treatment Table (WSRS) score
Time frame: Blind investigators graded the severity of wrinkles at 1 month, 6 months, and 12 months after the last treatment Table (WSRS) score
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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