Improved appearance of moderate to severe to heavy bulge or fullness of under the chin of adults
Conditions
Interventions
C group:Administer the experimental drug deoxycholic acid injection to the subjects, with a concentration of 10mg/ml deoxycholic acid injection. Subcutaneous inject 0.2m of the injection at each injec
A group:Administer the experimental drug deoxycholic acid injection to the subjects, with a concentration of 10mg/mL deoxycholic acid injection. Subcutaneous inject 0.2ml of the injection at each inje
D group:Give the subject a positive control drug deoxycholic acid injection (Belkyra) deoxycholic acid injection
B group:Administer the experimental drug deoxycholic acid injection to the subjects, with a concentration of 10mg/m deoxycholic acid injection. Subcutaneous inject 0.1ml of the injection solution at e
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 years old (including 18 or 65 years old), regardless of gender; 2. The researchers rated the appearance of excessive fat accumulation under the edible, heavy bulging or fullness according to the CR-SMFRS scale, that is, subjects with a chin fat score of 2 and 3 points; 3. According to the researcher, have enough chin fat for safe subcutaneous fat injection (at least 20 stitches); 4. According to the researcher's judgment, at least 6 months before screening weight stability, that is, weight fluctuations of not more than ±10% within 6 months; 5. Subjects can fully understand this clinical trial, have good compliance, and have reasonable expectations for treatment effect; 6. Female subjects did not have unprotected sex within two weeks before screening; male subjects (or their partners) or female subjects did not have a fertility plan or sperm donation plan during the entire trial period and within 3 months after the end of the trial, and were able to take effective contraception; 7. voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have an allergic reaction to the previous antioxychoic acid or other components of the test drug, have a history of allergies to the surface or local anesthesia (e.g. lidocaine, benzocaine, Prucaine, etc.), or allergic to the substance; 2. Have previously received any intervention to treat under-the- Dennis Fat or any treatment that may have been evaluated in the neck or lower wards area that may have been administered in the past: a) Surgery at the lower geese site (e.g., buried wire surgery, etc.), liposuction treatment or injection of lipid-soluble drugs similar to those used in the test (e.g. phosphatidylcholine, etc.); b) within 12 months before screening, skin fillers (e., hyaluronic acid, lyco., etc.); 3. Plans to receive cosmetic operations on sub- Dennis sites during the study period, including but not limited to dermal filling, facial peeling, photoelectric therapy, water photonics, microneedles, chemical peeling or scar surgery; 4. Have a previous history of surgery in the jaw or neck area, or a significant scar, infection, cancer or precancerous lesions under the jaw, and/or unhealed wounds, jaw contractions (a type of deteriorating denture due to insufficiency in the development of the edible or congenital lack of lower vertebral dentures and insufficiency of the fins), after evaluation by the investigator may affect the evaluation results; 5. with dermatitis, acne and other phlegm of the neck skin disease or scar physique (previously has a tendency to proliferate or scars), which may affect the evaluation results as determined by the researcher; 6. Subjects who have previously received poor lipolytic treatment or serious adverse reactions; 7. found that there are other causes (such as goiter, lymph node swelling, cervical lymph node disease, Madron disease, resting state of the neck broad muscle, etc.) caused by the increase in the area of the lower denture affect the evaluation of the fat condition under the denture, after the researcher judged that it is not appropriate to participate in this test; 8. glycated hemoglobin (HbA1c) >=6.5% or fasting blood sugar >= 7.0 mmol/L; 9. Those with impaired liver function, i.e. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal values, or the upper limit of the normal value of total bilirubin (TBIL) > 2 times the upper limit of normal values; 10. renal insufficiency, that is, the estimated glomerular filtration rate calculated by the CKD-EPI creatinine equation defined by the KDIGO 2012 classification (eGFR =40 kg/m^2 at screening; 12. have symptoms or medical history of swallowing; 13. Subjects judged by the researchers with severe loosening of the skin under their chin; 14. Medications that prolong the clotting time (e.g. aspirin, non-steroidal anti-inflammatory drugs, clopidogrel, warfarin, etc.) within 2 weeks prior to screening, or any anticoagulant drugs (including but not limited to warfarin, heparin) that are required during the trial; 15. Use topical medications (e.g. glucocorticoids, vitamin A-acid ointments) on the skin under the jaw within 4 weeks prior to screening, or expect to use these drugs at the lower end of the test (12 weeks after the last injection); 16. According to the researchers, the dissolution of the densate will cause the submental skin laxity grade (SMSLG) of the subcutaneous skin laxity (SMSLG) of the lower chin or other anatomical chara
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate pain visual analog score on the day of injection therapy and within 1 week +/- 2 days after injection therapy;Evaluation of submental skin laxity on the first week +/- 2 days after injection therapy;Evaluation of the occurrence of all adverse events (type of adverse events, incidence, etc.) on the day of injection treatment and the first week after injection treatment +/- 2 days;Evaluate the occurrence of specific adverse reactions on the day of injection therapy and on the first week +/- 2 days after injection therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics indicators;12 weeks after the last treatment, the change in submental fat thickness confirmed by caliper measurement relative to baseline;Evaluation of submental skin laxity during subsequent treatment and follow-up periods;12 weeks after the last treatment, the proportion of subjects with a Self Rating Satisfaction Scale (SSRS) score of 4-6;12 weeks after the last treatment, the proportion of subjects whose submental fat volume confirmed by ultrasound decreased by at least 10% relative to baseline;4 weeks and 12 weeks after the last treatment, the total score of the submental fat impact scale (PR-SMFIS) and the changes in the scores of each dimension of the PR-SMFIS scale reported by the subjec;Evaluate the occurrence of specific adverse reactions during subsequent treatment and follow-up periods;At 4 and 12 weeks after the last treatment, the under-daised fat assessment scale (CR-SMFRS) score reported by clinicians and the under-daised fat rating scale (PR-SMFRS) score reported by the partici;4 and 12 weeks after the last treatment, clinicians reported a lower-hijab fat assessment scale (CR-SMFRS) score and a participant-reported under-the-daised fat assessment scale (PR-SMFRS) score compa;Visual Analog Scale (VAS) score for pain assessment during subsequent treatment and follow-up periods;Evaluate the occurrence of all adverse events during the subsequent treatment and follow-up periods;12 weeks after the last treatment, the proportion of subjects whose submental fat volume was confirmed to have decreased by at least 10% relative to baseline by magnetic resonance imaging (MRI) measure;The proportion of subjects who responded effectively to the Overall Satisfaction Questionnaire (SGQ) 12 weeks after the last treatment.;safety; | — |
Countries
China
Contacts
Public ContactLong Xiao
Peking Union Medical College Hospital
Outcome results
None listed