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A prospective, multicenter, randomized controlled, blinded clinical study evaluating the safety and efficacy of injectable modified sodium hyaluronate gel for lip fillers

A prospective, multicenter, randomized controlled, blinded clinical study evaluating the safety and efficacy of injectable modified sodium hyaluronate gel for lip fillers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054328
Enrollment
Unknown
Registered
2021-12-13
Start date
2019-08-31
Completion date
Unknown
Last updated
2022-11-14

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

Conditions

None listed

Interventions

Treatment group:Hyaluronic acid filler for injection
Control group:None

Sponsors

Union Hospital Affiliated to Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Normal adults in China, aged 18-60 years; 2. There is a need for lip fillers to improve the shape and fullness of the lips, with a 5-level Lip Fullness Scale (LFS) score of 1, 2 or 3; willing to perform injections and follow-up as required by the trial; 3. According to the 5-level grading scale of lip morphology, those who hope to improve by 1 magnitude after treatment; 4. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Past medical history: (1) There are abnormal marks (patterning, perforation), color, mass, scar, etc. on the surface of the lip. (2) There are permanent or semi-permanent fillers and tumors inside the lips. (3) Abnormal morphological changes of the structures (teeth, gums, alveolar bone, etc.) behind the lips. (4) Lip and lip and nose deformities. 2. History of present illness: Degradable injection fillers, new organisms, scars, infections, wounds, exfoliative treatment of epidermis, depilation of the adjacent parts of the lips, etc. have been performed on the lips within one year. Those who had implanted semi-permanent fillers within 24 months, or planned to receive such injections in the face during the trial. 3. Systemic conditions: those with the following conditions: abnormal blood coagulation function, bleeding tendency, pregnant or lactating women (planned to conceive in the experimental stage), subjects with scarring constitution, subjects with severe diabetes, hyperthyroidism, epilepsy, subjects with severe organic diseases, autoimmune diseases, allergic diseases. Those who are undergoing symptomatic treatment for the above-mentioned diseases. 4. Psychological abnormalities or mentally ill subjects. 5. All staff conducting this study.

Design outcomes

Primary

MeasureTime frame
Evaluation of the effectiveness of lip fillers in subjects at 3 months post-injection;

Countries

China

Contacts

Public ContactChen Xiaosong

Union Hospital Affiliated to Fujian Medical University

chenxiaosong74@163.com+86 591 86218405

Outcome results

None listed

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