Nasolabial Fold WrinklesNCT07367204
Randomized Masked Trial of Injectable Cross-Linked Hyaluronic Acid for Moderate-to-Severe Nasolabial Folds
A study testing Intense and Restylane in people with Nasolabial Fold Wrinkles, run by Chongqing Jinsaixing Medical Technology Co., Ltd at 1 site in China.
Trial summary
The objective of this clinical trial is to evaluate the efficacy and safety of injectable cross - linked hyaluronic acid gel for correcting moderate to severe nasolabial fold wrinkles, on the premise of ensuring the safety of subjects and the scientific rigor of the clinical trial. Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- Nasolabial Fold Wrinkles
- What is being tested?
- Intense and Restylane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2025to 6 Mar 2027
- 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 26 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 26 years (inclusive), regardless of gender;
- Subjects willing to correct nasolabial fold wrinkles;
- Subjects with bilateral nasolabial folds having the same WSRS grade (both Grade 3 or both Grade 4) as assessed by masked evaluators;
- Subjects who can understand the purpose of the study, voluntarily participate, and are willing to sign a written informed consent form.
Who cannot join
- Subjects with known allergies to hyaluronic acid products or any components of the investigational medical device/control medical device; or subjects with a known history of severe allergies or anaphylactic shock;
- Subjects with abnormal coagulation function at screening (Activated Partial Thromboplastin Time [APTT] > 1.5 × upper limit of normal [ULN]), or those who have used any thrombolytics, anticoagulants, or antiplatelet drugs (e.g., warfarin, aspirin, etc.) within 2 weeks prior to screening;
- Presence of tattoos, piercings, significant facial hair, scars, deformities, unhealed wounds, abscesses, granulomas, active or persistent perinasal infections, malignancies or precancerous lesions, malignant tumors, or skin masses of unknown nature in the injection area and adjacent sites that may affect efficacy assessment or increase treatment risks;
- Presence of active skin diseases, inflammation, or infections (e.g., herpes, acne, eczema, dermatitis, psoriasis, shingles, mycosis, papilloma, etc.) that, in the investigator's judgment, may affect efficacy assessment or increase treatment risks;
- Subjects who have received or plan to receive surgical treatments for facial wrinkle improvement (e.g., autologous fat transplantation, absorbable suture embedding therapy, or facelift surgery) in the injection area and adjacent sites within 12 months prior to screening or during the study, which, in the investigator's judgment, may affect efficacy assessment or increase treatment risks;
- Subjects who have received or plan to receive injections of any permanent fillers (e.g., polymethylmethacrylate [PMMA], silicone, expanded polytetrafluoroethylene [ePTFE], etc.) or other unknown materials in the injection area and adjacent sites;
Show all 21Show fewer
- Subjects who have received or plan to receive treatments with calcium hydroxylapatite, poly-L-lactic acid [PLLA], polylactic acid, poly-DL-lactic acid [PDLLA], polycaprolactone [PCL], etc., in the injection area and adjacent sites within 24 months prior to screening or during the study;
- Subjects who have received or plan to receive cross-linked sodium hyaluronate injection therapy in the injection area and adjacent sites within 12 months prior to screening or during the study;
- Subjects who have received or plan to receive any cosmetic treatments or facial surgeries (e.g., botulinum toxin therapy, non-cross-linked sodium hyaluronate filling, collagen filling, radiofrequency therapy, focused ultrasound therapy, intense pulsed light [IPL], laser therapy, medium or deeper chemical peels, dermabrasion, liposuction, fat dissolution, photodynamic therapy, or other ablative surgeries, etc. [excluding mesotherapy]) in the injection area and adjacent sites within 6 months prior to screening or during the study;
- Subjects who have received or plan to receive mesotherapy, photobiomodulation (e.g., red and blue light, excluding laser therapy), intense pulsed light, microneedling (excluding radiofrequency microneedling), or very superficial or superficial chemical peels (e.g., retinol, alpha-hydroxy acids [AHAs], salicylic acid, etc.) in the injection area and adjacent sites within 3 months prior to screening or during the study;
- Subjects with active autoimmune diseases (e.g., inflammatory bowel disease) or a history thereof, or active connective tissue diseases (e.g., rheumatoid arthritis, scleroderma, and systemic lupus erythematosus) or a history thereof;
- Subjects who have received chemotherapy, immunosuppressant therapy, immunomodulator therapy (e.g., monoclonal antibodies, etc.), or systemic corticosteroid therapy (excluding inhaled corticosteroids) within 3 months prior to screening; or those who have taken retinoids within 6 months prior to screening; or those who have received any drug therapy within 1 month prior to screening or within 5 drug half-lives (whichever is longer), which, in the investigator's judgment, may affect efficacy assessment or increase treatment risks;
- Subjects with a history of keloid formation, tendency to develop hypertrophic scars, or any other healing disorders;
- Subjects with significant facial edema or diseases expected to cause facial edema during the study, which, in the investigator's judgment, may affect injection safety or efficacy assessment;
- Subjects with severe impairment of major organ function (brain, heart, lungs, liver, kidneys, etc.) as judged by the investigator, such as severe cardiovascular and cerebrovascular diseases (hospitalization for myocardial infarction or cardiac surgery within 3 months, history of congestive heart failure or myocardial infarction, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm, stroke, etc.), severe pulmonary diseases (moderate to severe pneumonia, respiratory failure, etc.), uncontrolled diabetes mellitus, epilepsy, or history of severe mental illness, psychological disorders, visual impairment, etc.;
- Subjects with full dentures or any devices covering all or part of the palate, severe malocclusion, dental or maxillofacial deformities, or significant perioral asymmetry, which, in the investigator's judgment, may affect efficacy assessment or increase treatment risks;
- Subjects who have received or plan to receive dental treatments that may affect efficacy assessment (e.g., tooth extraction, orthodontic treatment, dental implants, etc.) within 3 months prior to screening or during the study;
- Subjects planning to have a significant weight change (>10% body weight change) during the clinical trial;
- Female subjects who are pregnant, lactating, or planning to conceive during the clinical trial;
- Subjects currently participating in other clinical trials, or those who participated in a drug clinical trial within 3 months, or a medical device clinical trial within 1 month (excluding cases where only informed consent was signed without receiving any intervention);
- Other conditions deemed inappropriate for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: A Prospective, Multicenter, Randomized, Parallel-Controlled, Subject- and Investigator-Masked, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of Cross-Linked Hyaluronic Acid Gel for Injection in Correcting Moderate to Severe Nasolabial Folds
The objective of this clinical trial is to evaluate the efficacy and safety of injectable cross - linked hyaluronic acid gel for correcting moderate to severe nasolabial fold wrinkles, on the premise of ensuring the safety of subjects and the scientific rigor of the clinical trial.
- Conditions
- Nasolabial Fold Wrinkles
- Being tested
- Intense, Restylane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntenseDevice
Correction of moderate to severe nasolabial fold wrinkles
RestylaneDevice
the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
| Study group | Role | What they receive |
|---|---|---|
| Intense | Experimental | Not described Receives: Device: Intense |
| Restylane | Active comparator | Not described Receives: Device: Restylane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate of nasolabial fold wrinkle improvement at 180 ± 14 days after the last injection (assessed by masked evaluators).
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start24 Feb 2025
- Primary completion26 Apr 2026 (estimated)
- Study completion6 Mar 2027 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Jinsaixing Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367204
- Sponsor's protocol ID
- GS-OM003-PCT01
- Status last verified
- Dec 2025
- First submitted
- 17 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Parallel-Controlled, Subject- and Investigator-Masked, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of Cross-Linked Hyaluronic Acid Gel for Injection in Correcting Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT07367204
- Acronym / sponsor ID
- GS-OM003-PCT01
- Conditions
- Nasolabial Fold Wrinkles
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Chongqing Jinsaixing Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 26 Apr 2026 (estimated)
- Study completion
- 6 Mar 2027 (estimated)
- First posted
- 26 Jan 2026 (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.
The objective of this clinical trial is to evaluate the efficacy and safety of injectable cross - linked hyaluronic acid gel for correcting moderate to severe nasolabial fold wrinkles, on the premise of ensuring the safety of subjects and the scientific rigor of the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intense | Experimental | Device: Intense |
| Restylane | Active comparator | Device: Restylane |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 26 years (inclusive), regardless of gender;
- Subjects willing to correct nasolabial fold wrinkles;
- Subjects with bilateral nasolabial folds having the same WSRS grade (both Grade 3 or both Grade 4) as assessed by masked evaluators;
- Subjects who can understand the purpose of the study, voluntarily participate, and are willing to sign a written informed consent form.
Key exclusion criteria (21 listed)
- Subjects with known allergies to hyaluronic acid products or any components of the investigational medical device/control medical device; or subjects with a known history of severe allergies or anaphylactic shock;
- Subjects with abnormal coagulation function at screening (Activated Partial Thromboplastin Time [APTT] > 1.5 × upper limit of normal [ULN]), or those who have used any thrombolytics, anticoagulants, or antiplatelet drugs (e.g., warfarin, aspirin, etc.) within 2 weeks prior to screening;
- Presence of tattoos, piercings, significant facial hair, scars, deformities, unhealed wounds, abscesses, granulomas, active or persistent perinasal infections, malignancies or precancerous lesions, malignant tumors, or skin masses of unknown nature in the injection area and adjacent sites that may affect efficacy assessment or increase treatment risks;
- Presence of active skin diseases, inflammation, or infections (e.g., herpes, acne, eczema, dermatitis, psoriasis, shingles, mycosis, papilloma, etc.) that, in the investigator's judgment, may affect efficacy assessment or increase treatment risks;
- Subjects who have received or plan to receive surgical treatments for facial wrinkle improvement (e.g., autologous fat transplantation, absorbable suture embedding therapy, or facelift surgery) in the injection area and adjacent sites within 12 months prior to screening or during the study, which, in the investigator's judgment, may affect efficacy assessment or increase treatment risks;
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 |
|---|---|---|
| IntenseCorrection of moderate to severe nasolabial fold wrinkles | Device | Intense |
| Restylanethe Correction of Midface Volume Deficiency and/or Midface Contour Deficiency | Device | Restylane |
Primary outcome
Effective rate of nasolabial fold wrinkle improvement at 180 ± 14 days after the last injection (assessed by masked evaluators).
Time frame: 180 days
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 26 Jan 2026.
Related trials for Nasolabial Fold Wrinkles
Active, not recruiting
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Nasolabial Fold
Active, not recruiting
Hyaluronic Acid Crosslinking Clinical Study
Facial Aging, Skin Aging
Active, not recruitingObservational study
Filler Post Market Survey (FIPS)
Wrinkle Reduction
Active, not recruiting
Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds
Nasolabial Folds, Wrinkles
Active, not recruiting
Safety and Effectiveness of ELLANSÉ®-S Dermal Filler in the Treatment of Nasolabial Folds
Nasolabial Folds
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. This study is not recruiting at the moment.
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 Intense and Restylane in people with Nasolabial Fold Wrinkles, run by Chongqing Jinsaixing Medical Technology 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 4 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. 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 nasolabial fold wrinkle improvement at 180 ± 14 days after the last injection (assessed by masked evaluators). (time frame: 180 days). 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 26 Jan 2026.