Subjects across groups present with moderate to severe facial aesthetic concerns, including peri-oral lines, nasolabial folds, lip volume deficits, and cheeks/cheekbones volume deficit, as gauged by various dermatological scales Skin and Connective Tissue Diseases
Conditions
Interventions
75 will be treated in total with Hydragel C divided into groups :
Group 1: At least 25 subjects treated in peri-oral lines and lips contour
Group 2: At least 25 subjects treated in nasolabial folds an
Sponsors
Louna Aesthetics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subject 2. Sex: male or female 3. Age: between 18 and 70 years 4. Subject seeking an improvement of her/his face aspect with HA filler *For group 1: Subject with moderate to severe peri-oral lines (score 3 to 5 on Bazin Upper lip scale) and lips contour requiring redefinition *For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on the WSRS scale) and/or seeking an improvement of lip volume (score 1 or 2 for superior and/or inferior lip on the Rossi scale) *For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit (score 3 to 4 on Ascher lipoatrophy scale) 5. Subject with a stable weight for the last 6 months and who agrees to keep a stable weight during the study 6. Subject having given her/his free, express, and informed consent 7. Subject psychologically able to understand the information related to the study, and to give their written informed consent 8. Subject registered with a social security scheme 9. Women of childbearing potential should use a contraceptive method considered effective for at least 12 weeks and throughout the study
Exclusion criteria
Exclusion criteria: Population: 1. Pregnant or nursing woman or planning a pregnancy during the study 2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship 3. Subject in a social or sanitary establishment 4. Subject suspected to be non-compliant according to the investigator’s judgment 5. Subject having received a total of 6000 euros as compensation for her/his participation in clinical research in the last 12 months, including their participation in the present study 6. Subject enrolled in another study or whose non-enrollment period is not over 7. Subject with scar(s), mole(s), hair or any other lesion on the studied zones which might interfere with the evaluation (tattoo, permanent make-up) Associated pathology: 8. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety 9. Subject with known history of or suffering from autoimmune disease and/or immune deficiency 10. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, severe acne, severe rosacea, porphyria) in the 6 months before screening visit 11. Subject with a history of streptococcal disease or an active streptococcus infection 12. Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders 13. Subject predisposed to keloids or hypertrophic scarring or having healing disorders 14. Subject having a history of severe allergy or anaphylactic shock including known hypersensitivity to one of the ingredients of the investigational device (i.e. HA), seafood, to antiseptic solution (Diaseptyl®) or to lidocaine amide-type anaesthetics (EMLA®), related to previous or current treatments Previous or ongoing treatment: 15. Subject having received a dose of COVID-19 vaccine within the 14 days prior to injection or planning to receive a dose in the 3 weeks following injection 16. Any medication which may interfere, at the interpretation of the investigator, with the study objectives 17. Subject having received treatment with a laser, ultrasound or radiofrequency treatment, a dermabrasion, surgery, a chemical peeling or any other procedure based on active dermal response on the face within the past 6 months or who plans to undergo any of these procedures during the study 18. Subject having received within the past 18 months or planning to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., HA, Calcium Hydroxyapatite) or autologous fat on or near the treated zone 19. Subject having received within the past 9 months or planning to receive during the study any injections outside of those in the study protocol including mesotherapy or botulinum neurotoxin on or near the treated zone 20. Subject having received at any time or planning to receive a permanent filler on the face (e.g., polylactic acid, Polymethylmethacrylate, silicone) during the study. 21. Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand) 22. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit or being a chronic user 23. Subject undergoing a topical treatment on the test area or a systemic treatment: 23.1. Anti-inflammatory medication a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aesthetic improvement measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by an independent live assessor 1 month after treatment (M1) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The safety of the HYDRAGEL C range and of each HYDRAGEL C device independently will be assessed by: 1.1. Collection of immediate and early Injection Site Reactions (ISRs) by the subjects on a daily log every day up to 1 month after treatment 1.2. Collection of immediate and early ISRs by the independent investigator immediately and one (M1), six (M6) and twelve months (M12) after treatment 1.3. Collection of AEs throughout the study 2. Proportion of subjects having an improvement of the zone treated with the overall HYDRAGEL C range of devices as assessed using the GAIS by an independent investigator, six (M6) and twelve (12M) months after treatment 3. Proportion of subjects having an improvement of the zone treated with each HYDRAGEL C device for the four indications independently as assessed using the GAIS by an independent investigator, one (M1 ), six (M6) and twelve (12M) months after treatment 4. Proportion of subjects having an improvement of the zone treated with the HYDRAGEL C range of devices overall as assessed using the GAIS by the subjects, one (M1), six (M6) and twelve (12M) months after treatment 5. Proportion of subjects having an improvement of the zone treated with each HYDRAGEL C device for the four indications independently as assessed using the GAIS by the subjects, one (M1), six (M6) and twelve (12M) months after treatment 6. Evaluation of the effectiveness on wrinkles/lines filling of the device HYDRAGEL C1 used in the peri-oral lines as assessed using the Bazin Upper lip wrinkles scale by an independent investigator one (M1), six (M6) and twelve (12M) months after treatment 7. Evaluation of the effectiveness on lips volume increase of the device HYDRAGEL C2 used in lips as assessed using the Rossi scale by an independent investigator one (M1), six (M6) and twelve (12M) months after treatment 8. Evaluation of the effectiveness on folds filling of the device HYDRAGEL C2 used in the nasolabial folds as assessed using the WSRS scale by an inde | — |
Countries
France
Outcome results
None listed