The Correction of Midface Volume Deficiency and/or Midface Contour Deficiency

NCT07359079 | Active Not Recruiting

• 1 other identifier: GS-OM002-PCT01
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief 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 trial.

Conditions

the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Study Arms (2)

Stimulate

EXPERIMENTAL

Procedure: Stimulate

Restylane Volyme

ACTIVE COMPARATOR

Biological: Restylane Volyme

Interventions

Stimulate PROCEDURE

the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency

Stimulate

Restylane Volyme BIOLOGICAL

the Correction of Midface Volume Deficiency and/or Midface Contour Deficiency

Restylane Volyme

Eligibility Criteria

• Age: 26 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• 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.

Sponsors & Collaborators

• Chongqing Jinsaixing Medical Technology Co., Ltd: lead

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subject-Blinded, Evaluator-Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: March 19, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 27, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-11

Locations

CN (1)