Effectiveness and Safety of Cellbooster Shape in Healthy Subjects

SUISSELLE has developed a CE marketed (2021) HA-based superficial epidermis/dermis injection filler and skinbooster product, Cellbooster® Shape (CBS). CBS is produced using patented CHAC Technology. It consists of non-crosslinked HA with L-Carnitine and vitamin C. The device is particularly designed for reducing local puffiness by improving microcirculation and hydration. The current post-market clinical investigation is designed to evaluate the efficacy and safety of CBS. For this purpose, healthy subjects with signs of skin aging in the face will receive a 3-session treatment and will be followed-up over 70 days after the initial injection session. Several objective measurements of skin quality will be performed with different instruments allowing to assess skin volume, skin elasticity, skin hydration, and skin microcirculation. Subjective clinical improvement will be evaluated, as well as subject and investigator satisfactions. The safety of the injections will be assessed by collecting the Injection Site Reactions (ISRs) and Adverse Events (AEs).

Inclusion Criteria: 1. Healthy subject. 2. Sex: male and female. 3. Phototype II to IV. 4. Age: from 35 years old. 5. Subject with light to moderate signs of cutaneous ageing of the face. 6. Subject with a skin hydration rate on cheekbones \< 60 UA, measured with Corneometer®. 7. Subject with light to moderate localized submental (double chin) and/or malar puffiness (at least 35 in each indication). 8. Subject looking for an anti-age improvement using an aesthetic procedure. 9. Subject willing to abstain from other facial aesthetic procedure in the full face through the entire study duration. 10. Subject having given their free, express, and informed consent. 11. Subject psychologically able to understand the information related to the study, and to give their written informed consent. 12. Subject registered to a social security scheme. 13. Female of childbearing potential must use a medically accepted contraceptive method since at least 12 weeks before the beginning of the study and throughout the study. 14. Female subjects of childbearing potential must have a negative pregnancy test at the inclusion. Exclusion Criteria: In terms of 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 participating to another research on human beings or being in an exclusion period for a previous study. 5. Subject having received a total of 6.000 euros as compensation for their participation in research involving human beings in the last 12 months, including their participation in the present study. 6. Intensive exposure to sunlight or UV-rays within the previous month and/or planning to do so during the study. In terms of associated pathology 17. Subject with ongoing uncontrolled depression and/or recently recovered (\