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)

NCT ID: NCT06703294

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Intentional Correction of Forehead Wrinkles (crow's Feet)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Varying degrees of crow's feet

Bovine collagen filling crow's feet

Group Type: OTHER

Crow's feet injection filling

Intervention Type: PROCEDURE

Patients with crow's feet of different degree were randomly divided into two groups, which were injected with bovine collagen and humanized collagen respectively

Humanized collagen filling crow's feet

Intervention Type: PROCEDURE

Bovine collagen filling crow's feet

Interventions

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

Intervention Type: PROCEDURE

Humanized collagen filling crow's feet

Bovine collagen filling crow's feet

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Seventh Medical Center of the Chinese People's Liberation Army General Hospita

UNKNOWN

Sponsor Role: collaborator

Fiman (Changchun) Pharmaceutical Biotechnology Company Limited

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hongqiang Li HQ Li

Role: CONTACT

azhudezhuziyu@163.com

0431-85085090

Other Identifiers

FimanPharma

Identifier Type: -

Identifier Source: org_study_id