Randomized Masked Trial of Injectable Cross-Linked Hyaluronic Acid for Moderate-to-Severe Nasolab… (NCT07367204) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Randomized Masked Trial of Injectable Cross-Linked Hyaluronic Acid for Moderate-to-Severe Nasolabial Folds
China356 participantsStarted 2025-02-24
Plain-language 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.
Who can participate
Age range26 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged ≥ 26 years (inclusive), regardless of gender;
✓. Subjects willing to correct nasolabial fold wrinkles;
✓. Subjects with bilateral nasolabial folds having the same WSRS grade (both Grade 3 or both Grade 4) as assessed by masked evaluators;
✓. Subjects who can understand the purpose of the study, voluntarily participate, and are willing to sign a written informed consent form.
Exclusion criteria
✕. 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;
✕. 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;
✕. 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;
✕. 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;
✕
What they're measuring
1
Effective rate of nasolabial fold wrinkle improvement at 180 ± 14 days after the last injection (assessed by masked evaluators).
Timeframe: 180 days
Trial details
NCT IDNCT07367204
SponsorChongqing Jinsaixing Medical Technology Co., Ltd
. 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;
✕. 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;
✕. 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;
✕. 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;