Volume loss in the mid - face and/or mid - face contour defec
Conditions
Interventions
Control group:The subjects in the control group will receive the treatment with the control medical device, Restylane Volyme, on Day 0.
Experimental group:The subjects in the experimental group will receive the treatment with the investigational medical device, Stimulate, on Day 0.
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
26 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subjects aged >= 26 years old (including 26 years old), regardless of gender; 2.Subjects who have the intention to correct the volume loss of the midface and/or the contour defects of the midface; 3.According to the evaluation by the blinded evaluator, each side of the subject has mild to severe volume loss of the midface and/or contour defects of the midface (MMVS classification is grade 2 to 4). It is not required that both sides have the same MMVS 4.classification, but the difference in MMVS classification between the two sides should be <= 1 grade; 4.Subjects who can understand the purpose of the trial, voluntarily participate in the trial, and are willing to sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects who are known to be allergic to hyaluronic acid products or any component of the test medical device/control medical device; or subjects with a known history of severe allergies or anaphylactic shock. 2.Subjects with abnormal coagulation mechanisms during the screening period (Activated Partial Thromboplastin Time (APTT) > 1.5 times the upper limit of the normal value), or those who have used any thrombolytic agents, anticoagulants, or antiplatelet drugs (such as warfarin, aspirin, etc.) within 2 weeks before screening. 3.Tattoos, piercings, obvious facial hair, scars, deformities, unhealed wounds, abscesses, granulomas, cancerous or pre-cancerous lesions, malignant tumors, or skin masses of unknown nature, etc. in the injection area and adjacent areas that may affect the evaluation of the curative effect or increase the treatment risk. 4.Subjects suffering from active skin diseases, inflammation, or infections (such as herpes, eczema, acne, dermatitis, psoriasis, shingles, mycosis, papilloma, etc.). 5.Subjects who have received or plan to receive facial rhytidectomy during the trial period. 6.Subjects who have received or plan to receive full-face surgical procedures in the injection area and adjacent areas during the trial period (such as autologous fat transplantation, absorbable suture implantation treatment, liposuction, lipolysis, etc.). 7.Subjects who have received or plan to receive full-face surgical procedures in other facial areas (excluding the injection area and adjacent areas) within 24 months before the screening period or during the trial period (such as autologous fat transplantation, absorbable suture implantation treatment, liposuction, lipolysis, etc.). 8.Subjects who have received or plan to receive any treatment with permanent fillers (such as polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, etc.) or injection treatment with other unknown materials in the injection area and adjacent areas during the trial period. 9.Subjects who have received or plan to receive treatments with calcium hydroxyapatite, poly-L-lactic acid, polylactic acid, poly-dioxanone-lactic acid, polycaprolactone, etc. in the injection area and adjacent areas within 24 months before the screening period or during the trial period. 10.Subjects who have received or plan to receive cross-linked sodium hyaluronate injection treatment in the injection area and adjacent areas within 12 months before the screening period or during the trial period. 11.Subjects who have received or plan to receive any cosmetic treatments or facial surgeries in the injection area and adjacent areas within 6 months before the screening period or during the trial period (such as botulinum toxin treatment, non-cross-linked sodium hyaluronate filling, collagen filling, radiofrequency treatment, focused ultrasound treatment, photon treatment, laser treatment, medium or deeper chemical peeling, dermabrasion, photodynamic therapy, or other ablation surgeries (excluding hydro-needling treatment)). 12.Subjects who have received or plan to receive hydro-needling treatment, photobiomodulation treatment (such as red and blue light, excluding laser treatment), intense pulsed light treatment, microneedling treatment (excluding radiofrequency microneedling), extremely superficial or superficial chemical peeling treatment (such as retinol, alpha-hydroxy acid, salicylic acid, etc.) in the injection area and adjacent areas within 3 months before the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of improvement in mid-facial volume deficiency and/or mid-facial contour defect at 6 months after the last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale for Pain Score;The improvement rate of the Global Aesthetic Improvement Scale (GAIS).;The effective rate of improvement in mid-facial volume deficiency and/or mid-facial contour defect;The effective rate of improvement in mid-facial volume deficiency and/or mid-facial contour defect;Subjects' Satisfaction Evaluation; | — |
Countries
China
Contacts
Public ContactXiao Long
Peking Union Medical College Hospital
Outcome results
None listed