Facial aging including temporal hollowing, mid face volume deficit, jawline ptosis and chin retrusion Skin and Connective Tissue Diseases
Conditions
Interventions
There are 2 treatment groups, the MaiLi Volume and the MailLi Extreme groups. Participants in the MaiLi Volume group will receive treatment in the mid-face and/or temples, will participants in the Mai
Sponsors
Sinclair Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be generally healthy and 25-65 years of age at Screening Visit 2. Subjects who have: 2.1. Mild to significant volume deficit in the mid-face (score of 2-4 on the designated photographic assessment scale) or 2.2. Mild to moderate jawline ptosis (score of 1-2 on the designated photographic assessment scale) or 2.3. Minimal to severe chin retrusion (score of 1-3 on the designated photographic assessment scale) or 2.4. Minimal to severe temporal hollowing (score if 2-4 on the designated photographic assessment scale) 3. Subjects who are willing to provide written informed consent, including approval for facial photographs to be taken. 4. Subjects willing to commit to having no further facial aesthetic treatments (see Table 2), that could affect the appearance of the facial treatment area, for the duration of the study period, including follow-up. 5. Subjects must be willing and able to comply with protocol requirements, instructions, and protocol-stated restrictions and be likely to complete the study as planned. 6. Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during all the study.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: 1. Subjects who, in the twelve months prior to their enrolment assessment had undergone: 1.1. cosmetic facial plastic surgery (other than rhinoplasty), 1.2. tissue grafting (e.g., fat injections), 1.3. tissue lifting implants (e.g., threads, barbs) or other implants, 1.4. augmentation with any permanent or semi-permanent filler (e.g., silicone, PMMA, PLLA) or temporary filler (e.g., Ha, CaHA, PCL) 1.5. neuromodulator injections, 1.6. mesotherapy, 1.7. resurfacing in the mid-face (e.g., laser, radio frequency, dermabrasion, or chemical peel) in the region of the face to be treated. 2. Subjects who have received other facial aesthetic procedures, that affects the appearance of the facial treatment, at any time during the study period. 3. Subjects currently enrolled in other clinical trials. 4. Subjects with facial hair as this could interfere with study evaluations. 5. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship. 6. Subject is an employee of the aesthetic surgery department on the investigational site, the CRO or study sponsor. 7. Pregnant or nursing woman or planning a pregnancy during the study. 8. Subjects taking thrombolytics or anticoagulants. 9. Subjects with bleeding disorders. 10. Subjects with known hypersensitivities to hyaluronic acid, lidocaine, amide local anaesthetics or other components of the treatment. 11. Subjects with a history of severe allergy or anaphylactic shock. 12. Subjects with active (or a history of) autoimmune disease. 13. Subjects with porphyria. 14. Subjects with cutaneous disorders and areas affected by inflammation and/or infectious skin problems (e.g., acne, herpes) at or near the treatment site. 15. Subjects with a tendency to form keloids, hypertrophic scars or any other healing disorders. 16. Subject with known history of precancerous lesions/skin malignancies. 17. Subjects must avoid receiving COVID-19 vaccination for the 14 days before and following injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluate the proportion of subjects with an improvement (score of 3 and above) at 6 months in the Global Aesthetic Improvement Scale (GAIS) with assessments of: • MaiLi Volume as a treatment for mid-face volume deficit and temporal hollowing. • MaiLi Extreme as a treatment for mid-face volume deficit, jawline ptosis and chin retrusion. as determined by an on-site live independent evaluator. 2. Evaluate safety through the collection of all adverse events, inclusive of Serious Adverse Events (SAE), unanticipated problems 3. Unanticipated Adverse Device Effects (UADE), experienced in the post-treatment follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of subjects with an improvement (score of 3 and above) in Global Aesthetic Improvement Scale (GAIS) assessments of the i) mid-face and ii) jawline and iii) chin area and iv) temple at 3, 12, 18 and 24 months by an on-site live independent evaluator. 2. The proportion of subjects with an improvement (score of 3 and above) in Global Aesthetic Improvement Scale (GAIS) assessments of the i) mid-face and ii) jawline iii) chin area and iv) temple at 3, 6, 12, 18 and 24 months by the subject. 3. The proportion of subjects exhibiting an improvement of = 1 point from baseline on the mid-face volume deficit scale at 3, 6, 12, 18 and 24 months as rated by a blinded independent evaluator. or The proportion of subjects exhibiting an improvement of = 1 point from baseline on the scale for the assessment of jawline sagging at 3, 6, 12, 18 and 24 months as rated by a blinded independent evaluator. or The proportion of subjects exhibiting an improvement of = 1 point from baseline on the chin retrusion assessment scale at 3, 6, 12, 18 and 24 months as rated by a blinded independent evaluator. or The proportion of subjects exhibiting an improvement of = 1 point from baseline on the temporal hollowing assessment scale at 3, 6, 12, 18 and 24 months as rated by a blinded independent evaluator. 4. Subject and investigator treatment satisfaction will be assessed by questionnaire at 3, 6, 12, 18 and 24 months | — |
Countries
Belgium, Germany
Contacts
Public ContactMegan;Max Qin;Wang
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Outcome results
None listed