A post-market clinical follow-up study of Perfectha Subskin Lidocaine
- Conditions
- A range of Fitzpatrick skin types presenting significant loss of volume in the cheeks, jawline and/or chinSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN63865080
- Lead Sponsor
- Sinclair Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 69
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Global Aesthetic Improvement Scale (GAIS) assessments as rated by an on-site live independent evaluator at baseline and 3 months<br>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.<br>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 Outcome Measures
Name Time Method