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Efficacy and Safety of Cross-linked Sodium Hyaluronate for the Treatment of Moderate-to-Severe Neck Wrinkles: A Prospective, Multicenter, Randomized, Single-Blind Clinical Trial

Efficacy and Safety of Cross-linked Sodium Hyaluronate for the Treatment of Moderate-to-Severe Neck Wrinkles: A Prospective, Multicenter, Randomized, Single-Blind Clinical Trial - Efficacy and Safety of Cross-linked Sodium Hyaluronate for the Treatment of Moderate-to-Severe Neck Wrinkles

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102839
Enrollment
Unknown
Registered
2025-05-20
Start date
2022-05-20
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Wrinkles

Interventions

Experimental group:The experimental group received Rinkles?, a cross-linked sodium hyaluronate (HA) gel containing 15 mg/mL of cross-linked sodium hyaluronate, 3 mg/mL of lidocaine hydrochloride, phos
The control group:The control group received a non-cross-linked HA compound containing 5.00 mg/mL of sodium hyaluronate, 2.00 mg/mL of L-carnosine, 0.10 mg/mL of glycine, 0.10 mg/mL of alanine, 0.20 m

Sponsors

The First Affiliated Hospital of Xi 'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18 =2 for neck wrinkles judged by the researcher; 4. Subjects who voluntarily sign informed consent and have good compliance; 5. The investigator evaluated the subjects deemed suitable for inclusion.

Exclusion criteria

Exclusion criteria: 1. Patients with serious systemic diseases, such as myocardial infarction, stroke, cancer, connective tissue diseases (such as scleroderma, systemic lupus erythematosus), systemic infections, diabetes, blood and lacrimal diseases, etc., and those who may require immunosuppressive drugs during the trial; 2. History of neck skin disease, cicatricial constitution or foreign body granuloma; 3. Pregnant or lactating women, who have a pregnancy plan during the test; 4. People with abnormal spirits; 5. Have a history of allergy, allergic to narcotic drugs; 6. Subjects with severe cardiac or renal dysfunction (aspartate aminotransferase AST or alanine aminotransferase ALT exceeding 3 times the upper limit of the normal range; Severe kidney disease; Serum creatinine > 2.0mg/dL or >=176.8µmol/L); 7. Patients with abnormal hypersensitivity; 8. Patients with abnormal coagulation function and clinical significance; 9. Participants in clinical trials of other drugs or medical devices within six months; 10. No history of submental chemical exfoliation, laser or scar removal, no history of submental skin relaxation treatment within six months; 11. Subjects that the investigator considers inappropriate to participate in this clinical validation.

Design outcomes

Primary

MeasureTime frame
llergan Transverse Neck Lines Scale;

Secondary

MeasureTime frame
llergan Transverse Neck Lines Scale;Global Beauty Results Satisfaction;Pain evaluation;

Countries

China

Contacts

Public ContactMaoguo Shu

The First Affiliated Hospital of Xi'an Jiao Tong University

shumaoguo@163.com+86 186 2945 2016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026