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A prospective, multicenter, randomized, blinded, parallel-controlled, non-inferiority clinical trial of recombinant type III collagen implants for facial augmentation to correct facial wrinkles

A prospective, multicenter, randomized, blinded, parallel-controlled, non-inferiority clinical trial of recombinant type III collagen implants for facial augmentation to correct facial wrinkles

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054338
Enrollment
Unknown
Registered
2021-12-14
Start date
2021-12-16
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

Group A:Recombinant human type III collagen filler
Group B:Summax collagen filler

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 (inclusive), gender is not limited; 2. Those seeking to correct facial wrinkles, including frown lines, forehead lines, and crow's feet; 3. Severity score of static wrinkles >= grade 2; 4. The subjects voluntarily participated in this trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. The subject has local anesthetics (such as lidocaine, etc.) and collagen allergy; 2. The subject has a history of keloid or bleeding; 3. The subject has active inflammation in the area to be treated (such as local cysts, papules, nodules, pustules, cancer/precancerous lesions or any other skin disease); 4. Subjects suffering from clinically important diseases (such as major laboratory test abnormalities, myocardial infarction, stroke, cancer, connective tissue disease, systemic infection, uncontrolled diabetes, etc.) within 3 months before the start of the study; 5. Subjects may need to use immunosuppressive drugs during the trial (such as severe, uncontrolled asthma, rheumatoid arthritis, autoimmune diseases, etc.); 6. The subject has abnormal coagulation function or is using anticoagulant drugs, such as aspirin, non-steroidal anti-inflammatory drugs, etc., which will increase the degree of bleeding at the implantation site according to the judgment of the investigator; 7. Subjects plan to undergo major facial surgery (such as rhinoplasty, face lift, congenital defect repair, etc.) or medical cosmetic related treatments (such as laser, botulinum toxin injection, hyaluronic acid, etc.) during the research process; 8. The subject's face has been treated with wrinkle correction or botulinum toxin injection, laser or plastic surgery within 6 months; 9. Subjects should not use swine-derived medical products (control products) due to religion, ethnicity and other reasons; 10. The subject is planning to become pregnant, is pregnant or is breastfeeding during the study period. The subject must have a negative blood or urine pregnancy test before receiving the study treatment; 11. Subjects participated in clinical trials of other drugs or medical devices within 3 months before the screening visit of this clinical trial; 12. Subjects who are not suitable for participating in this trial due to other reasons such as poor compliance or perception disorder assessed by the investigator.

Design outcomes

Primary

MeasureTime frame
Facial wrinkle grade;

Countries

China

Contacts

Public ContactWu Sufan

Zhejiang Provincial People's Hospital

sufanwu@163.com+86 13857121888

Outcome results

None listed

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