New filler gel aims to restore midface fullness

NCT ID NCT07359079

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new injectable gel made from hyaluronic acid to correct volume loss in the midface area. It involves 356 adults with mild to severe midface deficiency. Participants receive either the new gel or a standard filler, and results are measured at 6 months for safety and effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PEGDE-crosslinked hyaluronic acid hydrogel
What this could lead to
If successful, this could offer a new, safe option for restoring midface fullness and contour.
What could go wrong
This is a non-inferiority trial, so the new gel may not be better than existing fillers. Results are based on cosmetic improvement at 6 months, and individual results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

356 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

26 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

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Contacts and locations

Locations

  • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100000, China