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A prospective, randomized, blank-controlled, blinded evaluation, superiority clinical trial evaluating the efficacy and safety of recombinant type III humanized collagen lyophilized fibers for injection

Clinical trial of superiority of recombinant type III collagen in improving facial skin condition and anti-aging

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066696
Enrollment
Unknown
Registered
2022-12-14
Start date
2022-12-14
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Improved skin condition

Interventions

test group:Recombinant Collagen Injection
Control Group:In the early stage, the blank control of the experimental group was used, and in the later stage, the injection was used as the self-control before and after

Sponsors

Plastic Surgery Hospital of Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) The age is 18~65 (inclusive), gender is not limited; 2) The subject's facial skin has two or more of the following skin aging symptoms: dry skin, rough skin, fine lines, enlarged pores, dull skin, etc. Questions; 3) The skin type is Fitzpatrick skin classification ??; 4) The subject maintains the existing skin care habits throughout the test period and does not make any changes; 5) The subject voluntarily participates in this test and signs the informed consent.

Exclusion criteria

Exclusion criteria: 1) Subjects are allergic to local anesthetics (such as lidocaine, etc.) and collagen; 2) Suffer from connective tissue diseases, or suffer from scar constitution; 3) Severe heart, liver, kidney function, and blood coagulation abnormalities ( Cardiac function: Grade III and above; ALT, AST > 3 times the upper limit of normal value; serum creatinine > 1.5 times the upper limit of normal value) or history of malignant tumors (diagnosed as malignant tumors in the past 5 years, the current condition is stable and Subjects who have received appropriate treatment or resection of thyroid cancer and cervical cancer in situ); 4) One of the following conditions exists in the facial test area: a) There are significant scars, wounds, tattoos, severe acne, etc. on the face that affect the efficacy of the face Evaluator; b) active inflammation or sensitive skin in the area to be treated; c) unavoidable exposure to intense ultraviolet (UV) radiation during the study (such as sunbathers or outdoor workers); d) planning to participate in the study Major facial surgery or medical cosmetology-related treatment during the process; 5) Major facial surgery, facial filler injection, exfoliative facial photoelectric therapy and other surgical treatments in the past 3 months, or shallow chemical peeling in the past 1 month 6) Those who have used or planned to use immunosuppressants, anticoagulant drugs or used external drugs on the face (such as sugar) in the past 3 months or planned to use them in the past 1 month Corticosteroids, tretinoin ointment); 7) Women who have family planning during the study period, or women who are pregnant or breastfeeding; 8) Those who have participated in or are currently participating in drug or device clinical trials within the past month; 9) The researcher evaluates the subjects who are not suitable for participating in this trial for other reasons such as poor compliance or perception impairment.

Design outcomes

Primary

MeasureTime frame
Global Aesthetic Improvement Scale, GAIS;

Countries

China

Contacts

Public ContactYan Yan

Plastic Surgery Hospital of Chinese Academy of Medical Sciences

yanyan201606@163.com13661348184

Outcome results

None listed

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