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Randomized Masked Trial of Injectable Cross-Linked Hyaluronic Acid for Moderate-to-Severe Nasolabial Folds

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

NCT07367204•Chongqing Jinsaixing Medical Technology Co., Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

26 - No limit years

Sex

ALL

Healthy Volunteers

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 more criteria

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

February 24, 2025

Primary Completion Date

April 26, 2026

Completion Date

March 6, 2027

Last Updated

January 26, 2026

Enrollment

356

ACTUAL participants

Conditions

Nasolabial Fold Wrinkles

Interventions

Intense

DEVICE

Restylane

DEVICE

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

NCT07255261

Lips EnhancementPerioral Wrinkles+3 more

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ENROLLING_BY_INVITATIONNA

Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles

NCT06854796

Nasolabial Fold Wrinkles

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Randomized Masked Trial of Injectable Cross-Linked Hyaluronic Acid for Moderate-to-Severe Nasolabial Folds

Inclusion Criteria

Exclusion Criteria

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles

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