the Correction of Midface Volume Deficiency and/or Midface Contour DeficiencyNCT07359079
The Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
A study testing Stimulate and Restylane Volyme in people with the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency, 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 PEGDE-crosslinked hyaluronic acid hydrogels for the correction of midface volume deficiency and/or midface contour deficiency, on the premise of ensuring the safety of the subjects and maintaining the scientific integrity of the clinical… Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
- What is being tested?
- Stimulate and Restylane Volyme
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2025to 27 Feb 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
- Age ≥ 26 (including 26 years old), male or female;
- Subjects willing to correct midface volume deficiency and/or midface contour deficiency;
- According to the assessment by the blinded evaluators, subjects must have mild to severe midface volume deficiency and/or midface contour deficiency on each side (MMVS grade of 2 to 4). It is not required for both sides to have the same MMVS grade, but the difference in MMVS grade between the two sides must be ≤ 1 grade;
- Subjects are able to understand the objective of the study, voluntarily participate in the study and are willing to sign a written ICF.
Who cannot join
- Subjects who meet any of the following exclusion criteria will be ineligible for enrollment in the study:
- 1. Subjects known to be allergic to hyaluronic acid products or to any component of the investigational medical device/control medical device; or subjects with a known history of severe allergies or anaphylactic shock.
- Subjects showing abnormal coagulation mechanism (activated partial thromboplastin time (APTT) >1.5 times the upper limit of normal) during the screening period, or those who have received any thrombolytic agent, anticoagulant or antiplatelet drugs (such as warfarin and aspirin) within 2 weeks before the screening.
- Having tattoos, piercings, prominent facial hair, keloids, deformities, non-healed wounds, abscesses, granuloma, malignancies or precancerous lesions, malignant tumors, or skin mass of unknown nature, etc. in the midface area that may affect the efficacy evaluation or increase the treatment risks.
- Judged by the investigators, subjects with active skin diseases, inflammation, or infections (such as herpes, eczema, acne, dermatitis, psoriasis, herpes zoster, fungal infections, papillomatosis, etc.) that may affect the assessment of midface.
- Subjects who have previously undergone facial surgery for wrinkle removal (such as subcutaneous separation and lifting, Superficial Musculo-Aponeurotic System (SMAS) separation and lifting, subperiosteal separation and combined wrinkle removal) or those intending to undergo facial surgery for wrinkle removal during the trial.
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- Subjects who have previously undergone face surgical procedures (such as autologous fat grafting, absorbable catgut embedding treatment, liposuction, lipolysis, etc.) in the midface area, or those intending to undergo such treatments during the trial.
- Subjects who have previously undergone face surgical procedures (such as autologous fat grafting, absorbable catgut embedding treatment, liposuction, lipolysis, rhytidectomy, etc.) in other sites of face (except in the midface area) within 24 months prior to the screening period, or those intending to undergo such treatments during the trial.
- Subjects who have previously received any permanent filler treatments (such as polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, etc.) or other unknown material injection therapy in the midface area, or those intending to undergo such treatments during the trial.
- Subjects who have received calcium hydroxylapatite, poly-L-lactic acid, poly-lactic acid, poly-di-spiralactic acid, polycaprolactone, etc. in the midface area within 24 months prior to the screening period, or those intending to undergo such treatments during the trial.
- Subjects who have received cross-linked hyaluronic acid injection in the midface area within 12 months prior to the screening period, or those intending to undergo such treatments during the trial.
- Subjects who have undergone any cosmetic treatments (such as botulinum toxin treatment, non-crosslinked sodium hyaluronate filler, collagen filler, radiofrequency treatment, focused ultrasound treatment, laser treatment, medium or deeper chemical peels, dermabrasion, photodynamic therapy or other ablation surgeries, etc. (except mesotherapy)) in the midface area within 6 months prior to the screening period, or those intending to undergo such treatments during the trial.
- Subjects who have received mesotherapy, photobiologic modulation therapy (red and blue light, etc., except laser therapy), intense pulsed light, microneedling (except radio frequency microneedles), very superficial or superficial chemical peels (such as retinol, alpha hydroxy acids, salicylic acid, etc.) in the midface area within 3 months prior to the screening period, or those intending to undergo such treatments during the trial.
- Subjects with active autoimmune diseases (such as inflammatory bowel disease) or a history of such diseases, as well as those with active connective tissue diseases (such as rheumatoid arthritis, scleroderma, and systemic lupus erythematosus) or a history of such diseases.
- Subjects who have received chemotherapy, immunosuppressive treatments, immunomodulators (such as monoclonal antibodies, etc.), or systemic corticosteroids (excluding inhaled corticosteroids) within 3 months prior to the screening period; or those who have received any drug treatments prior to screening that may affect efficacy evaluation or increase treatment risks in the investigator's judgment.
- Subjects with a history of keloids.
- Subjects with noticeable facial edema, as judged by the investigator, which may affect injection safety or effectiveness evaluation.
- Subjects with severe dysfunction of vital organs (brain, heart, lung, liver and kidney, etc.) based on evaluation by investigators, such as severe cardiovascular and cerebrovascular diseases (such as hospitalization for myocardial infarction or cardiac surgery within 3 months, a medical history of congestive heart failure or myocardial infarction, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm or stroke, etc.), severe lung diseases (such as moderate to severe pneumonia and respiratory failure, etc.), or uncontrolled diabetes mellitus, epilepsy, or history of severe mental illness, history of psychological illness, visual impairment, etc..
- Subjects with full dentures or any devices covering all or part of the upper palate, or with severe malocclusion, dental or maxillofacial deformities, or noticeable asymmetry around the mouth.
- Subjects who have undergone oral treatments (such as tooth extraction, orthodontics, or dental implants) within 3 months prior to the screening period that may affect efficacy evaluation, or those planning to undergo such treatments during the trial.
- Subjects planning to experience significant weight changes (weight change > 10%) during the clinical trial.
- Pregnant or breastfeeding female subjects, or subjects with plans for pregnancy during the clinical trial.
- Subjects who have participated or are participating in drug clinical trials within 3 months prior to the screening period, or who have participated or are participating in clinical trials for other medical devices within 1 month prior to the screening period (except those who have signed informed consent only and have not received any intervention).
- Other conditions that are considered by the investigator not suitable for enrollment in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: A Prospective, Multicenter, Randomized, Parallel-Controlled, Subject-Blinded, Evaluator-Blinded, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of PEGDE-crosslinked Hyaluronic Acid Hydrogels for the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
The objective of this clinical trial is to evaluate the efficacy and safety of PEGDE-crosslinked hyaluronic acid hydrogels for the correction of midface volume deficiency and/or midface contour deficiency, on the premise of ensuring the safety of the subjects and maintaining the scientific integrity of the clinical trial.
- Being tested
- Stimulate, Restylane Volyme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimulateProcedure or surgery
the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
Restylane VolymeBiological
the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
| Study group | Role | What they receive |
|---|---|---|
| Stimulate | Experimental | Not described Receives: Procedure: Stimulate |
| Restylane Volyme | Active comparator | Not described Receives: Biological: Restylane Volyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness rate of improvement for midface volume deficiency and/or midface contour deficiency at 6 months after the last injection (as assessed by the blinded evaluators).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start19 Mar 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Correction of Midface Volume Deficiency and/or Midface Contour DeficiencyStudies 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
- NCT07359079
- Sponsor's protocol ID
- GS-OM002-PCT01
- Status last verified
- Nov 2025
- First submitted
- 14 Jan 2026
- Last updated
- 22 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Parallel-Controlled, Subject-Blinded, Evaluator-Blinded, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of PEGDE-crosslinked Hyaluronic Acid Hydrogels for the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
- ClinicalTrials.gov ID
- NCT07359079
- Acronym / sponsor ID
- GS-OM002-PCT01
- 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
- 19 Mar 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 22 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 PEGDE-crosslinked hyaluronic acid hydrogels for the correction of midface volume deficiency and/or midface contour deficiency, on the premise of ensuring the safety of the subjects and maintaining the scientific integrity 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 |
|---|---|---|
| Stimulate | Experimental | Procedure: Stimulate |
| Restylane Volyme | Active comparator | Biological: Restylane Volyme |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 26 (including 26 years old), male or female;
- Subjects willing to correct midface volume deficiency and/or midface contour deficiency;
- According to the assessment by the blinded evaluators, subjects must have mild to severe midface volume deficiency and/or midface contour deficiency on each side (MMVS grade of 2 to 4). It is not required for both sides to have the same MMVS grade, but the difference in MMVS grade between the two sides must be ≤ 1 grade;
- Subjects are able to understand the objective of the study, voluntarily participate in the study and are willing to sign a written ICF.
Key exclusion criteria (24 listed)
- Subjects who meet any of the following exclusion criteria will be ineligible for enrollment in the study:
- 1. Subjects known to be allergic to hyaluronic acid products or to any component of the investigational medical device/control medical device; or subjects with a known history of severe allergies or anaphylactic shock.
- Subjects showing abnormal coagulation mechanism (activated partial thromboplastin time (APTT) >1.5 times the upper limit of normal) during the screening period, or those who have received any thrombolytic agent, anticoagulant or antiplatelet drugs (such as warfarin and aspirin) within 2 weeks before the screening.
- Having tattoos, piercings, prominent facial hair, keloids, deformities, non-healed wounds, abscesses, granuloma, malignancies or precancerous lesions, malignant tumors, or skin mass of unknown nature, etc. in the midface area that may affect the efficacy evaluation or increase the treatment risks.
- Judged by the investigators, subjects with active skin diseases, inflammation, or infections (such as herpes, eczema, acne, dermatitis, psoriasis, herpes zoster, fungal infections, papillomatosis, etc.) that may affect the assessment of midface.
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 |
|---|---|---|
| Stimulatethe Correction of Midface Volume Deficiency and/or Midface Contour Deficiency | Procedure or surgery | Stimulate |
| Restylane Volymethe Correction of Midface Volume Deficiency and/or Midface Contour Deficiency | Biological | Restylane Volyme |
Primary outcome
The effectiveness rate of improvement for midface volume deficiency and/or midface contour deficiency at 6 months after the last injection (as assessed by the blinded evaluators).
Time frame: 6 months
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 22 Jan 2026.
Related trials for the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency
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A Study to Evaluate the Long-term Safety and Effectiveness of Sculptra™
Midface Volume Deficit, Midface Contour Deficiency
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 Stimulate and Restylane Volyme in people with the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency, 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 24 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 22 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?
The effectiveness rate of improvement for midface volume deficiency and/or midface contour deficiency at 6 months after the last injection (as assessed by the blinded evaluators). (time frame: 6 months). 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 22 Jan 2026.