Evaluation of the Efficacy and Safety of Three Injectable Hyaluronic Acid-based Fillers: Art Filler® Fine Lines, Art Filler® Universal and Art Filler® Lips (AF4)

FILLMED

Status: Completed

Conditions: Loss of Face Volume

Treatments: Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04647513

AF4:2018-A02466-49

Details and patient eligibility

About

The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume and the aging process. These fillers (also known as soft tissue augmentation medical devices) can correct the skin depressions/wrinkles, balance the disproportions or correct topographical anomalies.

In this context, it is proposed to carry out in post-CE marking, an open, prospective and non-comparative study in order to document an adequate aesthetic correction of the most frequent areas treated with Art Filler Fine Lines, Art Filler Universal and Art Filler Lips as well as their immediate and long-term tolerance.

Enrollment: 232 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 8 patient groups

Art Filler Fine Lines (forehead)

Experimental group

Description:

Injection of Art Filler Fine Lines in Forehead wrinkles

Treatment:

Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)

Art Filler Fine Lines (upper lip)

Experimental group

Description:

Injection of Art Filler Fine Lines in upper lip wrinkles

Treatment:

Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)

Art Filler Fine Lines (cheek folds)

Experimental group

Description:

Injection of Art Filler Fine Lines in cheek folds

Treatment:

Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)

Art Filler Fine Lines (crow's feet)

Experimental group

Description:

Injection of Art Filler Fine Lines in crow's feet

Treatment:

Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)

Art Filler Universal (lips volume)

Experimental group

Description:

Injection of Art Filler Universal in lips

Treatment:

Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)

Art Filler Universal (nasolabial folds)

Experimental group

Description:

Injection of Art Filler Universal in nasolabial folds

Treatment:

Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)

Art Filler Lips (lips volume)

Experimental group

Description:

Injection of Art Filler Lips in lips

Treatment:

Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)

Art Filler Lips (very deep nasolabial folds)

Experimental group

Description:

Injection of Art Filler Lips in very deep nasolabial folds

Treatment:

Device: Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)