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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intentional Correction of Forehead Wrinkles (crow's Feet)
• Intervention / Treatment: Procedure: Crow's feet injection filling; Procedure: Humanized collagen filling crow's feet

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hongqiang Li HQ Li; Phone Number: 0431-85085090; Email: azhudezhuziyu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-65 years old (including 18 and 65 years old), regardless of gender; Intentional correction of forehead wrinkles (crow's feet);

Exclusion Criteria:

• Received bovine collagen fillers or hyaluronic acid within 12 months prior to enrollment

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Varying degrees of crow's feet; Bovine collagen filling crow's feet	Procedure: Crow's feet injection filling; Patients with crow's feet of different degree were randomly divided into two groups, which were injected with bovine collagen and humanized collagen respectively; Procedure: Humanized collagen filling crow's feet; Bovine collagen filling crow's feet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blind investigators graded the severity of wrinkles at 1 month, 6 months, and 12 months after the last treatment Table (WSRS) score	Blind investigators graded the severity of wrinkles at 1 month, 6 months, and 12 months after the last treatment Table (WSRS) score

Collaborators and Investigators

• Sponsor: Fiman (Changchun) Pharmaceutical Biotechnology Company Limited
• Collaborators: The Seventh Medical Center of the Chinese People's Liberation Army General Hospita

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FimanPharma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No