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safety and effectiveness of amalian SF 24 advanced hyaluronic acid gel for injection in correction of nasolabial folds: a prospective,muiti-center,randomized,single-blind,compare with similar product,non-inferior study

safety and effectiveness of amalian SF 24 advanced hyaluronic acid gel for injection in correction of nasolabial folds: a prospective,muiti-center,randomized,single-blind,compare with similar product,non-inferior study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035033
Enrollment
Unknown
Registered
2020-07-28
Start date
2020-07-31
Completion date
Unknown
Last updated
2020-08-03

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

Conditions

Nasolabial folds

Interventions

experimental group:amalian SF 24 advanced hyaluronic acid gel for injection

Sponsors

Nanfang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age from 18 to 60 years old (including boundary value), no gender limit; 2.Those who have nasolabial fold wrinkles (WSRS score is 4~5) and are willing to receive treatment of correction; 3.Agree not to receive any facial cosmetic treatments other than the experimental treatment during the trial period; 4.Sign the informed consent form and agree to participate in all visits, inspections and treatments in accordance with the requirements of the trial protocol.

Exclusion criteria

Exclusion criteria: 1.Those who have received silicone or other permanent filler filling treatment in the nasolabial fold area in the past, or the filler used in the filling treatment is unknown; 2.Those who have received hyaluronate acid gel injection in the nasolabial fold area in the past year; 3.Those who have undergone other surgical treatments to improve facial wrinkles, such as facial lift surgery or thread lift surgery; 4.Those who have received treatments such as radiofrequency, laser, botox injection, chemical ablation and liquid nitrogen cryotherapy to eliminate or reduce facial wrinkles in the past 6 months; 5.Those who have precancerous lesions or have a tendency to become cancerous on the facial skin, or those who have received partial radiation therapy on the facial skin; 6.The nasolabial fold wrinkles have been significantly hardened and cannot disappear by stretching 7.Those who have active skin diseases such as facial infections, arthritis, herpes, psoriasis; 8.Those who have autoimmune diseases or are receiving immunotherapy; 9.Those who have coagulopathy or using anticoagulant/antiplatelet drugs; 10.There are one or more abnormalities in blood routine, urine routine, liver function, and renal function (except those that the investigator judges are not clinically significant); 11.Those who have scar constitution, or easy to form keloid, or hypertrophic scar; 12.Women who are planning to become pregnant or breastfeeding; 13.Those who are allergic to hyaluronate acid or other materials involved in this trial; 14.Those who are still participating in other clinical trials within the past 3 months; 15.Those who have psychosis or currently taking antipsychotic drugs; 16.Participating in this trial is not suitable by the judgement from the investigator.

Design outcomes

Primary

MeasureTime frame
Effective Rate of Rrinkle Correction;

Secondary

MeasureTime frame
Wrinkle Severity Rating Scale;Global Aestheyic Improvement Scale;Maintenance Time of Rrinkle Improvement;Incidence of Remedial Treatment;

Countries

China

Contacts

Public ContactHu Zhiqi

Nanfang Hospital of Southern Medical University

13903050216@163.com+86 13903050216

Outcome results

None listed

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