A range of Fitzpatrick skin types presenting significant loss of volume in the cheeks, jawline and/or chin Skin and Connective Tissue Diseases
Conditions
Interventions
The injection will be administered slowly into the deep subcutaneous fat tissue and/or into the supraperiostic zone in the appropriate area of the face by a well-trained physician. The injection volum
Sponsors
Sinclair Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects between 25 and 65 years of age. 2. Subjects seeking an aesthetic improvement of volume loss in his/her cheeks, jawline and/or chin with hyaluronic acid dermal filler 3. Subjects who present significant loss of volume in the cheeks, jawline and/or chin as assessed by a suitable recognised photographic scale: 3.1. Mild to significant volume deficit in the mid-face (score of 2-4 on the designated photographic assessment scale, or 3.2. Mild to moderate jawline ptosis (score of 1-2 on the designated photographic assessment scale, or 3.3. Minimal to severe chin retrusion (score of 1-3 on the designated photographic assessment scale 4. Subjects who are willing to provide written informed consent, including approval for facial photographs to be taken. 5. Subjects willing to commit to having no further facial aesthetic treatments, that could affect the appearance of the facial treatment area, for the duration of the study period, including follow-up. 6. 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. 7. Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during the entire study.
Exclusion criteria
Exclusion criteria: 1. Subjects who, in the twelve months prior to their enrolment assessment have 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 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 a treatment with a permanent filler (e.g. silicone, PMMA, PLLA) in the region of the face to be treated. 3. Subjects who have received other facial aesthetic procedures (see Table 3), that affect the appearance of the facial treatment, at any time during the study period. 4. Subject is in institutional care. 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 Clinical Research Organisation (CRO) or study sponsor. 7. Pregnant or nursing woman or a woman planning a pregnancy during the study. 8. Subject who is not using or has changed or started their medically accepted contraceptive regimen or any other hormonal treatment during the 12 weeks prior to study entry. 9. Subjects who in the opinion of the investigator are unsuitable to take part in the study for scientific or medical reasons. 10. Subject suspected to be non-compliant according to the investigator’s judgment. 11. Subjects currently enrolled in other clinical trials. 12. Subjects with scar(s), mole(s), tattoo(s), semipermanent makeup or facial hair in the region to be treated as this could interfere with study evaluations. 13. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit and 1 month after treatment. 14. Subject with known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment. 15. Subjects with a tendency to form keloids, hypertrophic scars or any other healing disorders. 16. Subject receiving medical treatment that reduces or inhibits liver metabolism (cimetidine, beta blockers) 17. Subject with epilepsy not controlled by treatment. 18. Subject with known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement). 19. Subject suffering from active disease/symptoms such as inflammation, infection, tumours, psoriasis, allergic oedema, inflammatory and/or infectious cutaneous disorders (e.g., herpes, acne, rosacea) on the face within 6 months of the study entry. 20. Subjects with a history of any disease which may have resulted in changes to facial contour or oedema during the study period (e.g., facial psoriasis, herpes zoster). 21. Subject with known history of precancerous lesions/skin malignancies. 22. Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety. 23. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety. 24. Subject with major dental problems or subject who received oral surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Global Aesthetic Improvement Scale (GAIS) assessments as rated by an on-site live independent evaluator at baseline and 3 months In cases where more than one area is treated, the improvement relates to the primary treatment area. An independent GAIS score will be also recorded for each additional area in which the subject is injected to allow sub-group analysis of the GAIS score for each treatment area. 2. Adverse Events (AEs), inclusive of Serious Adverse Events (SAEs), Unanticipated Problems (UPs), and Unanticipated Adverse Device Effects (UADEs), experienced in the post-treatment follow-up period measured by monitoring throughout the invesigation. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Perfectha Subskin Lidocaine through: 1. Improvement (score of 3 and above) in Global Aesthetic Improvement Scale (GAIS) assessments of the i) cheeks, (ii) jawline and/or iii) chin area at 1, 6, 9, 12, and 18 months post treatment by an on-site live independent evaluator. 2. Improvement (score of 3 and above) in Global Aesthetic Improvement Scale (GAIS) assessments of the i) cheeks, (ii) jawline and/or iii) chin area at 1, 3, 6, 9, 12, and 18 months post treatment by the subject. 3. Improvement of = 1 point from baseline on the mid-face volume deficit scale at 1, 3, 6, 9, 12, and 18 months post treatment as rated by a blinded remote independent evaluator. 4. Improvement of = 1 point from baseline on the scale for the assessment of loss of volume at the jawline sagging at 1, 3, 6, 9, 12, and 18 months post treatment as rated by a blinded remote independent evaluator. 5. Improvement of = 1 point from baseline on loss of volume on the chin retrusion assessment scale at 1, 3, 6, 9, 12, and 18 months post treatment as rated by a blinded remote independent evaluator 6. Patient self-assessment of their overall satisfaction with the results of the treatment at 1, 3, 6, 9, 12, and 18 months post treatment. 7. Investigator satisfaction of the use of the medical device through an investigator satisfaction questionnaire. | — |
Countries
England, United Kingdom
Contacts
Public ContactSalvina Mletzko
Outcome results
None listed