mild to moderate chin retraction
Conditions
Interventions
Control group:None
Experimental group:Poly(caprolactone) gel for injection
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
21 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range of 21 to 65 years old (including threshold), gender not limited; 2. Subjects willing to undergo chin filling treatment; 3. The subject has mild to moderate chin retraction, with a GCRS score of 1-2; 4. Voluntarily sign an informed consent form, understand and accept the duration of the study, and be able and willing to comply with all requirements, including treatment, follow-up, and other research procedures as planned.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to polycaprolactone products or any ingredients in this product; 2. Known to have a history of severe allergic reactions or multiple severe allergies; 3. Individuals with abnormal coagulation mechanisms during the screening period (activated partial thromboplastin time (APTT)>1.5 times the upper limit of normal), or those who have received any thrombolytic, anticoagulant, or antiplatelet drugs (such as warfarin, aspirin, etc.) within 2 weeks prior to enrollment; 4. The chin has received any permanent or semi permanent fillers (such as hydroxyapatite calcium, polylactic acid, polymethyl methacrylate, organosilicon, expanded polytetrafluoroethylene, polycaprolactone, etc.), autologous fat, etc; 5. Within the 12 months prior to enrollment, the chin and/or lips have received temporary fillers such as sodium hyaluronate (including water light needle) or collagen injection therapy, facial lifting surgery (thread embedding), and other unknown material injections; 6. Within the 6 months prior to enrollment, the lower body has undergone any medical beauty treatment, such as botulinum toxin injection, radiofrequency therapy, ultrasound therapy, laser or chemical skin replacement surgery, skin grinding surgery, facial lifting surgery (including thread embedding), etc; 7. The chin has undergone surgery and the researchers have determined that it affects the efficacy score; 8. Tattoos, punctures, visible facial hair (such as beards), scars, deformities, unhealed wounds, active skin diseases or inflammations or infections (such as herpes, acne, eczema, dermatitis, psoriasis, shingles, etc.), abscesses, oral active or persistent infections, cancer or precancerous lesions that may affect efficacy evaluation or increase treatment risk in the lower area; 9. Subjects with active autoimmune diseases or a history of porphyria (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.); 10. Subjects with a tendency to form keloids, hypertrophic scars, or any other healing disorders; 11. Have received chemotherapy, immunosuppressants, immunomodulatory therapy (such as monoclonal antibodies), or systemic corticosteroids (excluding inhaled corticosteroids) within the past 3 months prior to enrollment; 12. According to researchers' judgment, those with severe dysfunction of important organs (brain, heart, lungs, liver, kidneys, etc.); Subjects with severe cardiovascular and cerebrovascular diseases, severe pulmonary diseases, liver function (ALT, AST)>2 times ULN, renal function (Cr)>1.5 times ULN, and diabetes patients with poor control; 13. Plan to perform any lower surface filling, wrinkle correction or surgery, or oral treatment during the study period (including tooth extraction, orthodontics, dental implants, except for other projects that do not affect the gums); 14. People with positive antibodies to human immunodeficiency virus (HIV), treponema pallidum, hepatitis C virus (HCV) or active hepatitis B; 15. Individuals with a long-term history of alcohol and drug abuse; 16. Pregnant or lactating women, or those of childbearing age who are unable to use effective contraception during the study period; 17. Individuals who have participated in any other investigational drugs, medical devices, or other interventional clinical trials within the three months prior to the screening period; 18. Researchers believe that patients with poor efficacy, safety evaluation, or compliance are affect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of improvement of chin retraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate of improvement of chin retraction;Global Aesthetic Improvement Scale,GAIS;Subject Satisfaction Score; | — |
Countries
China
Contacts
Public ContactSun Qiuning
Peking Union Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed