New gel aims to smooth wrinkles around the mouth
NCT ID NCT07367204
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 see if it can safely reduce moderate to severe smile lines (nasolabial folds). About 356 adults aged 26 and older will receive either the new gel or a similar product called Restylane. The main goal is to check how well the gel works at 6 months after the last injection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cross-linked hyaluronic acid gel
- What this could lead to
- If it works, this could offer a new option for reducing smile lines that lasts about 6 months.
- What could go wrong
- This is a cosmetic study, not a treatment for a disease. Results may not apply to everyone, and side effects like swelling or bruising are possible.
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
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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
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356 people
The number who actually took part.
- Started
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Feb 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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26 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Aged ≥ 26 years (inclusive), regardless of gender; 2. Subjects willing to correct nasolabial fold wrinkles; 3. Subjects with bilateral nasolabial folds having the same WSRS grade (both Grade 3 or both Grade 4) as assessed by masked evaluators; 4. Subjects who can understand the purpose of the study, voluntarily participate, and are willing to sign a written informed consent form. Exclusion Criteria: 1. 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; 2. 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; 3. 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; 4. 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; 5. 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; 6. 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; 7. 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; 8. 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; 9. 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; 10. 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; 11. 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; 12. 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; 13. Subjects with a history of keloid formation, tendency to develop hypertrophic scars, or any other healing disorders; 14. 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; 15. 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.; 16. 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; 17. 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; 18. Subjects planning to have a significant weight change (\>10% body weight change) during the clinical trial; 19. Female subjects who are pregnant, lactating, or planning to conceive during the clinical trial; 20. 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); 21. Other conditions deemed inappropriate for participation in the study by the investigator.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, 100000, China
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