Crow's feet
Conditions
Interventions
Experimental group:Recombinant Type III Humanized Collagen Lyophilized Fiber Facial Dermal Tissue Injection Filler to Correct Crow's Feet
Control group:Recombinant type III humanized collagen solution for injection to fill facial dermal tissue to correct dynamic forehead wrinkles (including glabellar
Sponsors
Beijing Traditional Chinese Medicine Hospital, Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Age range: 18 to 75 years old (inclusive of the cutoff points). No gender restrictions. (2)Individuals seeking to improve their crow’s feet wrinkles. (3)Blind researchers assessed the fish-mouth wrinkles using the Wrinkle Severity Grading Scale (WSRS) and rated them as 3 or 4 points. (4)Voluntarily participating in this clinical trial and signing the informed consent form as a participant.
Exclusion criteria
Exclusion criteria: (1)The facial area intended for treatment is accompanied by acute or progressive skin conditions (such as active acne, acute eczema, contact dermatitis, acute atopic dermatitis, psoriasis and other inflammatory diseases, vitiligo, etc.), herpes, open wounds, or has infectious or purulent lesions on the face. (2)Individuals whose facial treatment areas have previously received permanent fillers (such as autologous fat) or semi-permanent fillers (such as poly-L-lactic acid, polycaprolactone, calcium hydroxyapatite, etc.) within 24 months prior to screening, or who plan to receive permanent or semi-permanent filler treatments during the study. (3)The facial areas intended for treatment have received injections of other temporary fillers, such as cross-linked sodium hyaluronate or cross-linked collagen, within 12 months prior to screening. (4)Subjects whose facial treatment areas have undergone or are planned to undergo cosmetic surgery (such as facelifts, facial reconstruction, etc.) or medical cosmetic treatments (such as laser, radiofrequency, non-crosslinked sodium hyaluronate injections, collagen injections, botulinum toxin injections, retinoic acid, etc.) within six months prior to screening, which may affect the assessment of the efficacy of crow's feet treatment. (5)Individuals with a tendency for scar hypertrophy in the facial area to be treated or with a history of keloids (6)Those with a history of allergies to local anesthetics, recombinant proteins, or collagen, or with a history of severe allergies (7)Has autoimmune diseases or a medical history of them (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, etc.) (8)Exclude those who have received chemotherapy, immunosuppressive agents, immunomodulatory therapy (such as monoclonal antibodies), or systemic corticosteroids (excluding inhaled corticosteroids) within the past 3 months (9)Exclude individuals who have had severe or unstable cardiovascular or cerebrovascular disease, malignant tumors, or systemic infections in the past three months (10)Individuals with poor blood sugar control during the screening period (HbA1c > 7% or fasting blood glucose > 9 mmol/L) (11)During the screening period, abnormal liver and kidney function is clinically significant (aspartate aminotransferase and alanine aminotransferase >1.5 times the upper limit of normal, creatinine > upper limit of normal) (12)Platelet count below 50×10^9/L during the screening period, or abnormal coagulation function (activated partial thromboplastin time >1.5 times the upper limit of normal), bleeding tendency, or use of thrombolytic agents, anticoagulants (such as heparin, warfarin, sodium citrate, aspirin, etc.), or platelet aggregation inhibitors within 2 weeks, which the investigator believes may increase bleeding at the implantation site. (13)Pregnant or breastfeeding women, or those planning to become pregnant during the study (14)Participants who have taken part in any other interventional device clinical trials within one month prior to this study or in any drug clinical trials within three months prior to this study (15)Researchers consider individuals who are otherwise ineligible to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate of crow's feet correction assessed by blinded investigators three months after the subject's last treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blinded investigators evaluated the efficiency of crow's feet correction;The efficiency of crow's feet correction was evaluated by the injection investigator;Subject self-rated global cosmetic outcome (GAIS) was graded;Injector investigators evaluated the global Facial Cosmetic Outcome (GAIS) classification;Satisfaction of subjects; | — |
Countries
China
Contacts
Public ContactZhao Hongyi
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Outcome results
None listed