Ageing of the skin Skin and Connective Tissue Diseases
Conditions
Interventions
Lanluma V is a CE-marked medical device and is used within its intended use. Injection of Lanluma V at baseline is followed by retreatment at 2 months (following assessment of efficacy and safety) and
Sponsors
Sinclair Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects with type II or type III upper arms on the Arm Visual Analog Scale (Arm VAS) seeking treatment for rejuvenation of the upper arms 2. Female and male subjects between 40-65 years of age 3. 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 4. Subjects willing to commit to having no further aesthetic treatments, such as body contouring procedures, for the duration of the study period 5. Subjects willing to commit to having no further tattoos on the upper arms for the duration of the study period 6. Women 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 12 months prior to their enrolment assessment have undergone in the region of the upper arms: 1.1. Tissue grafting (e.g. fat injections) 1.2. Lipolysis 1.3. Tissue lifting implants (e.g. threads, barbs) or other implants 1.4. Augmentation with any permanent or semipermanent filler (e.g. silicone, PMMA, PLLA) 1.5. Temporary dermal filler injections (e.g., HA, CaHA, PCL) 1.6. Neuromodulator injections 1.7. Mesotherapy 1.8. Resurfacing (laser, radio frequency, dermabrasion, or chemical peel) 2. Subjects who have received treatment with a permanent filler (e.g. silicone, PMMA, PLLA) in the region of the upper arms 3. Subjects who have received any other aesthetic procedures in the region of the upper arms 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 Clinical Research Organisation (CRO) or the 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 skin laxity in the region of the upper arms 9. Subjects who, if female, are pregnant or plan to become pregnant during the study period 10. Subjects with known allergies to the product ingredients (i.e. poly-L-lactic acid (PLLA), sodium carboxymethyl cellulose (CMC), Mannitol) 11. Subjects must avoid receiving a Coronavirus Disease (COVID)-19 vaccination for the 14 days before and following the injection 12. Subject with a cutaneous disorder, inflammation, infection, significant scarring, open wounds, lesions or tattoos in the region of the upper arms 13. Subjects taking thrombolytics or anticoagulants 14. Subjects with bleeding disorders 15. Subjects with a history of severe allergy or anaphylactic shock 16. Subjects with active (or a history of) autoimmune disease 17. Subjects with porphyria 18. Subjects with a tendency to form keloids, hypertrophic scars or any other healing disorders 19. Subjects with a history of lymphedema in the arms
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 in the treated region(s) of the upper arm, 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 in Global Aesthetic Improvement Scale (GAIS) assessments of the treated upper arm at 2, 4, 12, 18 and 25 months, as assessed by an on-site independent evaluator and participant 2. The proportion of participants (%) exhibiting an improvement of =1 point from baseline on a photographic Arm Visual Analog scale at 2, 4, 6, 12, 18 and 25 months as assessed by a blinded remote independent evaluator 3. Treatment satisfaction based on questionnaires filled by the participants (at 2, 4, 6, 12, 18 and 25 months) and the investigators (straight after treatment) | — |
Countries
Spain
Contacts
Public ContactSalvinia Mletzko
Outcome results
None listed