Evaluation of the Efficacy and Safety of Three Injectable Hyaluronic Acid-based Fillers: Art Filler® Fine Lines, Art Filler® Universal and Art Filler® Lips

Launched by LABORATOIRES FILLMED · Nov 23, 2020

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects who had signed a written informed consent
• • 2. Man or Woman aged ≥ 19 years old
• • 3. Subject having a Fitzpatrick Phototype I to IV
• • 4. Subject having a score of ≥ 1 in the Global aesthetic scale scoring system on at least one area of interest (forehead wrinkles, upper lip wrinkles, cheek folds, crow's feet wrinkles, nasolabial folds and/or marionette wrinkles) and/or ≤ 2 for the lip volume
• • 5. Subject having at least one of the following scales by clinical scoring
• * For subjects injected by Art Filler Fine Lines:
• • a grade ≥ 3 and ≤ 6 on the upper lip wrinkles scale from Bazin
• • a grade ≥ 3 and ≤ 5 on the cheek folds scale from Bazin
• * For women :
• • a grade ≥ 2 and ≤ 5 on the forehead wrinkles scale from Bazin
• • a grade ≥ 2 and ≤ 6 on the crow's feet wrinkles scale from Bazin
• * For men :
• • a grade ≥ 2 and ≤ 6 on the forehead wrinkles from Bazin
• • a grade ≥ 2 and ≤ 6 on the crow's feet wrinkles from Bazin
• * For subjects injected by Art Filler Universal:
• • a grade ≥ 0 and ≤ 2 on the lip volume fullness scale from Medicis (if the subject would like a soft effect on his/ her lips)
• • For women, a grade ≥ 2 and ≤ 4 on the nasolabial folds scale from Bazin
• • For men a grade ≥ 2 and ≤ 4 on the nasolabial folds scale from Bazin
• * For subjects injected by Art Filler Lips:
• • a grade ≥ 0 and ≤ 2 on the lip volume fullness scale from Medicis (if the subject would like a plumpled effect on his/ her lips)
• • For women, a grade of 5 on the nasolabial folds scale from Bazin
• • For men a grade ≥ 5 on the nasolabial folds scale from Bazin
• • 6. Subject registered with health insurance regimen
• • 7. Woman agreeing to take a pregnancy test
• Exclusion Criteria:
• • 1. Subject currently participating in another clinical study related to pharmaceuticals or medical devices or being in exclusion period of another clinical study.
• • 2. Subject deprived of freedom by an administrative or legal decision
• • 3. Subject who has received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including participation in this study).
• • 4. Subject who had facial injections/implants of any non-absorbable fillers in her/his whole life.
• • 5. Subject who had laser sessions for skin rejuvenation or laser resurfacing during the 12 previous months or a surgical facelift during the 2 years before the study.
• • 6. Subject with a history of facial aesthetic injection (hyaluronic acid within the previous year, botulinum toxin within the last 6 months and long-term temporary injectable implants (semi-permanent implants) within the previous 2 years).
• • 7. Subject with a skin-retaining device on the face (mesh, gold wire, liquid silicone or other particulate material).
• • 8. Subject who underwent a non-invasive rejuvenation method such as moderate to deep peeling, ultrasound, radiofrequency devices or lasers within the last 6 months.
• • 9. Subject with a history of severe multiple allergies or anaphylactic shock.
• • 10. Subject with a known hypersensitivity to hyaluronic acid, Lidocaine and/or other components of Art Filler Fine Lines®, Art Filler Universal® and Art Filler Fine Lips® solutions.
• • 11. Subject with a known hypersensitivity to chlorhexidine.
• • 12. Subject with a known hypersensitivity to lidocaine or local amide anesthetics.
• • 13. Subject tending to develop inflammatory skin diseases or hypertrophic scars.
• • 14. Subject with a history of streptococcal disease (recurring angina, rheumatic fever).
• • 15. Subject with oral or injectable corticoid treatment (or not stopped for at least 3 months). Inhaled corticoids are permitted as well as topical corticotherapy not involving the head or the neck.
• • 16. Subjects with any concomitant treatment (or not stopped for at least a year) by immunosuppressant or chemotherapy.
• • 17. Subject with a history of radiotherapy involving the head and the neck within the previous year.
• • 18. Subject with a history or a disease associated to the autoimmune or connective tissue disease.
• • 19. Subject presenting on his/her face any skin disease, or an acute inflammatory reaction or a bacterial/viral infection or who had such an episode within the previous 6 weeks.
• • 20. Subject who took aspirin or anticoagulants at regular doses in the last 15 days prior to the act.
• • 21. Subject who has permanently been exposed to the sun or the UV during the last 15 days.
• • 22. Subject with a general pathology, skin disease, dermatosis, acute or chronic systemic disease, and/or taking a general or topical treatment that in the opinion of the investigator may interfere with the treatment or compromise the subject's participation in the study
• • 23. Pregnant or lactating woman.
• • 24. Subject with epilepsy not controlled by treatment.