NCT06854796

Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: Shaanxi Giant Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Trial name: Prospective, multicentre, randomized, blind, parallel-controlled clinical trial to evaluate the efficacy and safety of recombinant collagen gel for correcting moderate to severe nasolabial wrinkles Sponsor: Shaanxi Juzi Biotechnology Co., LTD Objective: To evaluate the efficacy and safety of recombinant collagen gel prepared by Shaanxi Juzi Biotechnology Co., LTD Experimental design: A prospective, multicenter, randomized, blind, parallel controlled experimental design was adopted, and the comparison type was non-inferiority test Sample size: 244 cases Experimental group: control group =1:1 Scope of application: It is suitable for injection into facial dermis or subcutaneous tissue to correct moderate and severe nasolabial wrinkles Case selection: Inclusion criteria (1) Age 18-65 years old (including the threshold value), male and female; (2) Those who have a need to improve nasolabial wrinkles and are rated moderate or severe (corresponding to a score of 3 or 4) on the bilateral nasolabial Wrinkles Severity Rating Scale (as assessed by blind investigators); (3) Voluntarily participate in this clinical trial and sign the subject informed consent.

Conditions

• Nasolabial Fold Wrinkles

Interventions

Type	Name	Description
DEVICE	Recombinant collagen gel	The test device uses a recombinant collagen gel developed by Shaanxi Juzi Biotechnology Co., Ltd., which is different from other designs. The main components of recombinant collagen gel are recombinant collagen, disodium hydrogen phosphate, potassium dihydrogen phosphate, sodium chloride, water for injection, after the injection, collagen can occupy a place at the injection site to improve the visual aging caused by soft tissue loss, wrinkles and depressions, and the special manufacturing process can ensure that the gel has smoothness and ductility, which helps to achieve a smooth and natural appearance, effectively and gradually improve wrinkles and plump cheeks.
DEVICE	collagen implant agent	1\. After the product is injected into the skin, the collagen implant forms a soft mesh structure through condensation, which can make up for skin defects. 2. After implantation of this product, the connective tissue cells around the implantation site will grow into the collagen network structure and gradually form a bionic structure similar to normal tissue. 3. This product is absorbable and degradable. The collagen implant will be gradually decomposed by protease in the body, and the pressure, elongation and hierarchy of the implant site tissue will affect the final degradation and duration.

Timeline

• Start date: 2025-01-10
• Primary completion: 2025-10-01
• Completion: 2026-12-31
• First posted: 2025-03-03
• Last updated: 2025-03-03

Locations

1 site across 1 country: China