crow's feet
Conditions
Interventions
Control Group:Collagen implant "Sunmax" Collagen Implant ?
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-65 years, gender not limited; 2) Those who need to improve crow's feet are rated as grade 2, grade 3 or grade 4; 3)Voluntarily participate in the clinical trial, sign the informed consent, and complete the follow-up as required; 4) Reliable contraceptive methods were used during the trial, and pregnancy tests were conducted before each injection.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women, or those who plan to become pregnant within 12 months after signing the informed consent; 2) Infection, lesions, inflammation, skin diseases (psoriasis, herpes simplex, etc.) on the whole face cancer or precancerous lesions or unhealed wounds with a history of head and neck radiotherapy during the screening period; 3) Abnormal coagulation mechanism (APTT>1.5 times the upper limit of normal value) in the screening period, or anticoagulant, antiplatelet or thrombolytic therapy (such as warfarin, heparin, aspirin, etc.) within two weeks; 4) Have a history of serious diseases of important organs (cardiovascular system, liver, lung, nervous system, kidney, etc.), or have autoimmune diseases, such as rheumatism, lupus erythematosus, or immune dysfunction, or are receiving immunosuppressive therapy during screening; 5) Received cross-linked sodium hyaluronate or other temporary filling agents within 12 months or non cross-linked sodium hyaluronate filling treatment within 6 months in periorbital region; 6) Those who have used permanent, semi permanent or unknown fillers in periorbital region; 7) Those who have received or plan to receive laser treatment, chemical peeling, botulinum toxin treatment, grinding, all kinds of rhytidectomy (ultrasonic wave, shock wave, radio frequency, IPL, etc) and any other treatment with skin irritation in periorbital region within 6 months; 8)There are implantable devices (mesh, gold wire, non absorbable line, liquid silica gel or other particulate materials) on the face of the subjects; 9) Subjects who had undergone or planned to undergo periorbital region surgery or facial surgery within 12 months, which affected the judgment of crow's feet; 10) Subjects known to be allergic to lidocaine or local amide anesthetics. 11) Those who have allergic history of hyaluronic acid products, have known allergic history of hyaluronic acid products or any component in this product, or have severe allergic reaction to a variety of substances, indicating severe allergic reaction; 12) Subjects who received oral or injection of corticosteroids (or did not stop taking corticosteroids for at least 3 months). Allow the use of inhaled corticosteroids and local cortical treatment that does not involve the head or neck; 13) Patients with a history of severe allergic reaction and multiple severe allergic reactions; 14) Scar constitution, scar and other factors that affect the visual effect evaluation; 15) Porphyria patients; 16) Those who participated in other interventional clinical trials within 3 months before this trial; 17) Those who are excluded from pig products by national culture and religious beliefs; 18) The investigator believes that it is not appropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of severity grading of crow's feet at the second month after injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score of pain degree at 0.5h, 1H and 2h after using medical devices;Compared with baseline, the changes of crow's feet evaluated by independent evaluators through photos at 21 days, 2, 3, 6, 9 and 12 months after injection;Compared with baseline, the changes of crow's feet evaluated by researchers at 21 days, 2, 3, 6, 9 and 12 months after injection;Compared with baseline, the improvement rate of crow's feet evaluated by independent evaluators through photos at 21 days, 2, 3, 6, 9 and 12 months after injection;Compared with baseline, the improvement rate of crow's feet evaluated by researchers at 21 days, 2, 3, 6, 9, and 12 months after injection;The improvement rate of GAIS evaluated by the researchers at 21 days, 2, 3, 6, 9 and 12 months after injection;The improvement rate of GAIS evaluated by subjects at 21 days, 2, 3, 6, 9 and 12 months after injection; | — |
Countries
China
Contacts
Public ContactLi Linfeng
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed