Eligibility |
Inclusion Criteria:
1. Healthy Subject.
2. Sex: male or female.
3. Age: between 18 and 65 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) ;
- For group 2: Subject with moderate to severe nasolabial folds (score 3 to 4 on
WSRS scale) and/or subject with thin lips (score
1 or 2 for superior and/or inferior lip on the Rossi scale) and seeking an
improvement of lip volume;
- For group 3: Subject with moderate to severe cheeks/cheekbones volume deficit
(score 3 to 4 on Ascher lipoatrophy scale);
- For group 4: Subject with moderate to severe cheeks/cheekbones volume deficit
(score 3 to 4 on Ascher lipoatrophy scale) and/or subject seeking improvement of
chin enhancement.
5. Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a
stable weight during the study.
6. Subject having given their 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
since at least 4 weeks and throughout the study
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 suspected to be non-compliant according to the investigator's judgment.
5. Subject having received a total of 4.500 euros as compensations for their
participation in research involving human beings 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…). In terms of
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, acne, 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
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