Nasolabial Fold WrinklesNCT06854796
Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles
A study testing Recombinant collagen gel and collagen implant agent in people with Nasolabial Fold Wrinkles, run by Shaanxi Giant Biotechnology Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasolabial Fold Wrinkles
- What is being tested?
- Recombinant collagen gel and collagen implant agent
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range of 18-65 years old (including threshold), regardless of gender;
- There is a need to improve nasolabial folds, and the bilateral nasolabial folds severity rating scale (WSRS) is rated as moderate or severe (corresponding to a score of 3 or 4) by blinded researchers;
- Voluntarily participate in this clinical trial and sign the informed consent form for the subjects.
Who cannot join
- Patients with acute or advanced skin diseases (vitiligo, psoriasis, eczema, etc.), obvious scars, active inflammation, infections (bacterial, fungal, viral), cancerous or precancerous lesions, or unhealed wounds in the nasolabial groove area;
- Those who have received permanent or semi permanent dermal filler treatment (such as hydroxyapatite calcium, polymethyl methacrylate, organosilicon, expanded polytetrafluoroethylene, etc.) at the folds of the nasolabial groove, or plan to receive filler treatment during the study period;
- Screening for individuals who have undergone facial plastic surgery or other cosmetic procedures at the intended injection site or lower middle part of the nasolabial fold in the previous 6 months, which may affect the WSRS rating (such as facial lifting surgery, botulinum toxin injection, etc.); Or those who plan to undergo any other facial surgery, medication, or laser treatment during the study period;
- Individuals who have received temporary filler injections such as cross-linked hyaluronic acid, collagen, or polylactic acid in the nasolabial groove area within the previous 12 months, or who have received non cross-linked sodium hyaluronate injections in the nasolabial groove area within the previous 6 months;
- Scar lumps, scar constitution, and individuals in the active phase of infectious diseases;
- Those who have bleeding tendency and used anticoagulants within 2 weeks (heparin, warfarin, sodium citrate, aspirin, etc.), uncontrolled diabetes (HbA1c ≥ 7.5%), malignant tumors and other serious systemic diseases, or autoimmune diseases, such as rheumatism, lupus erythematosus, or immune dysfunction;
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- Patients with platelet count below 50 × 109/L or abnormal coagulation mechanism (such as APTT ≥ 1.5 times the upper limit of normal) during the screening period;
- Abnormal liver and kidney function during the screening period (AST, ALT>1.5 times the upper limit of normal values or Cr>1.5 times the upper limit of normal values);
- Individuals who have a history of allergies or allergies to local anesthetics such as pig derived materials or collagen materials, potassium dihydrogen phosphate, disodium hydrogen phosphate, or lidocaine (allergic to one or more substances);
- Visual impairment that affects the subject's self-evaluation;
- Individuals with a history of psychological disorders and mental illnesses who are unable to cooperate during the trial period;
- Pregnant or lactating women, and those planning to conceive during the trial period;
- Individuals who have participated in clinical trials of other intervention devices or within 5 half lives of their last medication in a drug clinical trial within one month prior to the start of this trial;
- Researchers believe that participants should not participate in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Seventh Medical Center of the Chinese People's Liberation Army General Hospital
Beijing
About this study
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
- Being tested
- Recombinant collagen gel, collagen implant agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant collagen gelDevice
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.
collagen implant agentDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant collagen coagulation glue | Experimental | The recombinant collagen gel produced by Shaanxi Juzi Biotechnology Co., Ltd. was used for 1-2 injections. Receives: Device: Recombinant collagen gel |
| collagen implant agent | Active comparator | Treated with 1-2 injections of collagen implants for the treatment of nasolabial folds manufactured by Shuangmei Biotechnology Co., Ltd. Receives: Device: collagen implant agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate of correcting and improving nasolabial folds 90 days after the last injection
Evaluation method: Blind researchers trained in the Wrinkle Severity Rating Scale (WSRS) were used to grade the injection site photos of subjects before and after injection.
Evaluation criteria: Compared with the screening period, if the severity score of bilateral nasolabial folds is reduced by at least one level 90 days after the last injection, it is considered effective improvement. Otherwise, it is considered ineffective improvement.
Measured: 90 days ± 7 days after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start10 Jan 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Fold WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Giant Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854796
- Sponsor's protocol ID
- XG2412
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles
- ClinicalTrials.gov ID
- NCT06854796
- Acronym / sponsor ID
- XG2412
- Conditions
- Nasolabial Fold Wrinkles
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Shaanxi Giant Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant collagen coagulation glue | Experimental | Device: Recombinant collagen gelThe recombinant collagen gel produced by Shaanxi Juzi Biotechnology Co., Ltd. was used for 1-2 injections. |
| collagen implant agent | Active comparator | Device: collagen implant agentTreated with 1-2 injections of collagen implants for the treatment of nasolabial folds manufactured by Shuangmei Biotechnology Co., Ltd. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age range of 18-65 years old (including threshold), regardless of gender;
- There is a need to improve nasolabial folds, and the bilateral nasolabial folds severity rating scale (WSRS) is rated as moderate or severe (corresponding to a score of 3 or 4) by blinded researchers;
- Voluntarily participate in this clinical trial and sign the informed consent form for the subjects.
Key exclusion criteria (14 listed)
- Patients with acute or advanced skin diseases (vitiligo, psoriasis, eczema, etc.), obvious scars, active inflammation, infections (bacterial, fungal, viral), cancerous or precancerous lesions, or unhealed wounds in the nasolabial groove area;
- Those who have received permanent or semi permanent dermal filler treatment (such as hydroxyapatite calcium, polymethyl methacrylate, organosilicon, expanded polytetrafluoroethylene, etc.) at the folds of the nasolabial groove, or plan to receive filler treatment during the study period;
- Screening for individuals who have undergone facial plastic surgery or other cosmetic procedures at the intended injection site or lower middle part of the nasolabial fold in the previous 6 months, which may affect the WSRS rating (such as facial lifting surgery, botulinum toxin injection, etc.); Or those who plan to undergo any other facial surgery, medication, or laser treatment during the study period;
- Individuals who have received temporary filler injections such as cross-linked hyaluronic acid, collagen, or polylactic acid in the nasolabial groove area within the previous 12 months, or who have received non cross-linked sodium hyaluronate injections in the nasolabial groove area within the previous 6 months;
- Scar lumps, scar constitution, and individuals in the active phase of infectious diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant collagen gelThe 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 | Recombinant collagen coagulation glue |
| collagen implant agent1. 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. | Device | collagen implant agent |
Primary outcome
Effective rate of correcting and improving nasolabial folds 90 days after the last injection
Time frame: 90 days ± 7 days after the last injection
Evaluation method: Blind researchers trained in the Wrinkle Severity Rating Scale (WSRS) were used to grade the injection site photos of subjects before and after injection. Evaluation criteria: Compared with the screening period, if the severity score of bilateral nasolabial folds is reduced by at least one level 90 days after the last injection, it is considered effective improvement. Otherwise, it is considered ineffective improvement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant collagen gel and collagen implant agent in people with Nasolabial Fold Wrinkles, run by Shaanxi Giant Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective rate of correcting and improving nasolabial folds 90 days after the last injection (time frame: 90 days ± 7 days after the last injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.