Enhancement of the volume of the buttocks and correction of skin depressions such as cellulite Skin and Connective Tissue Diseases
Conditions
Interventions
Poly-L-lactic acid dermal filler (Lanluma X) is a CE-marked medical device and is injected at baseline and 2 months (following assessment of efficacy and safety). There is an optional retreatment of L
Sponsors
Sinclair Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Age
25 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who: 1.1 Are seeking buttock augmentation And/or 1.2. Are seeking treatment for reduction of mild to moderate (2-3) cellulite in the region of the buttocks and/or the back of the thighs when assessed using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2. Female and male subjects aged 25-50 years of age 3. Body mass index =30 kg/m² 4. Subjects who are willing to provide written informed consent including approval of the use of their data and photographs in this study and any subsequent publications or presentations 5. Subjects willing to commit to having no further aesthetic treatments in the buttocks and thighs, such as body contouring procedures, for the duration of the study period 6. Subjects willing to commit to having no further tattoos on the buttocks and thighs for the duration of the study period 7. Females 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 meeting any of the following criteria will be excluded from the study: subjects who, in the months prior to their enrollment assessment, have undergone any of the following treatments in the buttocks and thighs: 3 months prior: - Mesotherapy - Resurfacing (e.g., laser, radio frequency, dermabrasion, or chemical peel) 6 months prior: - Temporary filler (e.g., Ha, CaHA, PCL) - Neuromodulator injections 12 months prior: - Cosmetic plastic surgery in the area to be treated - Tissue grafting (e.g., fat injections) - Tissue lifting implants (e.g., threads, barbs) or other implants - Augmentation with semi-permanent filler (e.g., PLLA) 2. Previous augmentation with any permanent filler in the region of the buttocks or thighs 3. Subjects who have received any other aesthetic procedures in the region of the buttocks or thighs at any time during the study period 4. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship 5. Subject is an employee of the aesthetic surgery department on the investigational site, the Contract Research Organisation (CRO) or study sponsor 6. Subjects who in the opinion of the investigator are unsuitable to take part in the study for scientific or medical reasons 7. Subjects currently enrolled in other clinical trials 8. Excessive subcutaneous fat in the region of the buttocks and thighs 9. Excessive skin laxity in the region of the buttocks and thighs 10. Subjects who, if female, are pregnant or plan to become pregnant during the study period 11. Subjects with known allergies to the product ingredients (i.e. Poly-L-lactic Acid (PLLA), sodium carboxymethyl cellulose (CMC), Mannitol) 12. Subjects must avoid receiving a Coronavirus Disease (COVID) -19 vaccination for the 14 days before and following the injection. 13. Subjects with a cutaneous disorder, inflammation, infection, significant scarring, open wounds, lesions or tattoos in the region of the buttocks and thighs 14. Subjects taking thrombolytics or anticoagulants 15. Subjects with bleeding disorders 16. Subjects with a history of severe allergy or anaphylactic shock 17. Subjects with active (or a history of) autoimmune disease 18. Subjects with porphyria 19. Subjects with a tendency to form keloids, hypertrophic scars or any other healing disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants (%) with an improvement (i.e., improved, much improved or very much improved) over baseline at 6 months in Global Aesthetic Improvement Scale (GAIS) assessments of buttocks augmentation and/or cellulite appearance in buttocks/thighs, as assessed by an on-site independent evaluator | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of participants (%) with an improvement (i.e., improved, much improved or very much improved) over baseline at 6 months in Global Aesthetic Improvement Scale (GAIS) assessments of buttocks augmentation and/or cellulite appearance in buttocks/thighs at 2, 4, 12, 18 and 25 months, as assessed by an on-site independent evaluator and self-assessed by participants 2. The proportion of participants (%) exhibiting a reduction of =1 point from baseline in Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for cellulite appearance in buttocks and/or thighs at 2, 4, 6, 12, 18 and 25 months as assessed by a blinded remote independent evaluator 3. Participant and Investigator treatment satisfaction based on questionnaires completed by the participants (at 2, 4, 6, 12, 18 and 25 months post-treatment) and the investigators (after treatment) | — |
Countries
Spain
Contacts
Public ContactSalvinia Mletzko
Outcome results
None listed