Periorbital skin is dry, rough, and fine lines are visible
Conditions
Interventions
Test group:Inject the Recombinant type III humanized collagen solution for injection
Sponsors
Plastic Surgery Hospital, Peking Union Medical College Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Women between the ages of 30 and 60; 2.Subjects with periorbital skin that is dry, rough, and has visible fine lines that can be improved by treatment with the experimental medical device, as determined by the investigator, and with skin photodamage typing (Glogau typing) grades II to IV. 3.Subjects with a need to improve dry facial skin and fine lines; 4.At least one of the under-eye wrinkles or crow's feet rated 2-6 by the researcher's on-site use of Atlas Facial Mapping; 5.Subjects volunteered and signed an informed consent form and agreed to complete the follow-up visits specified in the trial.
Exclusion criteria
Exclusion criteria: 1.Subjects with facial scarring or skin disorders that may affect the determination of treatment efficacy, in the midst of an allergic attack, or in the presence of active infections (e.g., inflammatory acne, herpes simplex, etc.), and/or unhealed wounds, and in the midst of a progressive skin disease such as vitiligo or psoriasis; 2.The following procedures or treatments affecting this trial were performed prior to screening or are planned during the study period: a. Surgical treatments to improve facial wrinkles, such as silicone, autologous fat grafting, facelift surgery, thread lifting, and permanent dermal filler (e.g., polymethylmethacrylate, etc.) treatments, were performed prior to screening or are planned during the study period for the full body: a. Surgical treatments to improve facial wrinkles, such as silicone, autologous fat grafting, face lift surgery, thread lifting, permanent dermal filler (e.g., polymethyl methacrylate, etc.) treatments, were performed prior to screening or are planned during the study period for the full body b. Semi-permanent dermal filler (e.g., poly(L-lactic acid), hydroxyapatite, polycaprolactone, etc.) treatment, performed 18 months prior to screening or planned during the study period on the full face; c. Biodegradable dermal filler (e.g., sodium hyaluronate gel, collagen, etc.) treatment, performed 12 months prior to screening or planned during the study period on the full face; d. Botulinum toxin, aesthetic treatments, energy treatments other than light modulation therapy and intense pulsed light (IPL) treatment, performed 24 weeks prior to screening (6 months) or planned during the study period on the full face modulation therapy and intense pulsed light, energy-based devices (e.g., lasers, radiofrequency, ultrasound, etc.), dermabrasion, chemical peels of moderate or greater depth, or other exfoliative treatments (e.g., trichloroacetic acid, carbolic acid, fruit acids of 10% or greater concentration, or salicylic acid of 2% or greater concentration, etc.); e. Three (3) months prior to Screening, or planned for the study period, in the Full Dept: photomodulation therapy, intense pulsed light, superficial exfoliation or other exfoliative treatments (e.g., 10% or less concentration of fructic acid or 2% or less concentration of salicylic acid, etc.); 3.Subjects with a history of multiple severe allergies to any part of the body, hereditary allergies, those who are scheduled to undergo desensitization therapy during the study period, or those who are allergic to components of drugs or devices used in the experimental therapeutic approach (hyaluronic acid, streptococcal proteins, lidocaine or other amide anesthetics, etc.); 4.Subject has a history of coagulation abnormalities or has used or plans to use anticoagulant, antiplatelet, or thrombolytic therapy (e.g., warfarin, aspirin, etc.) within 14 days prior to screening; 5.Pregnant or breastfeeding, planning to become pregnant during the study period, or having a positive pregnancy test result during the screening period; 6.Subjects with a history of serious disease of vital organs or the presence of active autoimmune disease; 7.Those with proliferative scarring or keloid scarring; 8.Subjects who have participated in another clinical trial within 30 days prior to the Screening Period; 9.Subjects with other systemic diseases that, in the judgment of the investigator, make them unsuitable for participation in this trial; 10.Subjects who ar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in periorbital Global Aesthetic Effectiveness Scale (GAIS) score at 4 weeks (1 month) after the end of final treatment as assessed by the independent investigator; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of improvement in fine lines (under-eye wrinkles and crow's feet) assessed by the investigator using Atlas facial mapping was independently assessed at different follow-up nodes;Improvement in subjects' periorbital skin data collected by the VISIA Facial Imaging Instrument at different follow-up nodes compared to baseline;Improvement of Subjects' Cheek Skin Data Collected by the VISIA Facial Imaging Instrument at Different Follow-Up Nodes Compared to Baseline;Periorbital GAIS Improvement Rates Assessed by Subjects at Different Follow-up Nodes;Improvement rate of GAIS in the cheek as assessed by subjects at different follow-up nodes;Rate of improvement from baseline in subjects' eye status satisfaction and scores at different follow-up nodes (FACE-Q Satisfaction with eyes);Rate of improvement in investigator-assessed GAIS in the cheeks independently assessed at different follow-up nodes;Degree of improvement from baseline in subjects' facial skin condition satisfaction and scores at different follow-up nodes (FACE-Q Satisfaction with skin);Subject Outcome Satisfaction Scores at Different Follow-Up Nodes (FACE-Q Satisfaction with Outcome);Subject corneometer periocular skin hydration collected by the multifunctional skin tester Corneometer CM825 at different follow-up nodes;Skin hydration in the corneometer cheek area of subjects collected by the multifunctional skin tester Corneometer CM825 at different follow-up nodes; | — |
Countries
China
Contacts
Public ContactKeming Wang
Plastic Surgery Hospital, Peking Union Medical College Chinese Academy of Medical Sciences
Outcome results
None listed