Evaluation of the Efficacy and Safety of an Injectable Hyaluronic Acid-based Filler, Art Filler® Volume: Comparative Single-blind Study of the Non-inferiority Versus Juvéderm® Voluma on the Midface, Temple and Jaw-line and Non-comparative Study on the Chin. (AF3)

NCT04645576 | Completed

• 2 other identifiers: AF3:2018-A00287-482018-A00287-48
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume. These fillers (also known as soft tissue augmentation devices) can restore the age-related volume loss of the face, balance the disproportions or correct topographical anomalies. A previous study has already shown the efficacy of Art Filler Volume on the midface, but this study was not comparative. It was thus interesting to compare the efficacy of Art Filler Volume to a reference product but also to test its efficacy on other areas including the temple, jaw-line and chin.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Volume correction on D21 with Art Filler Volume product

  Objectively measure after a single injection of Art Filler® Volume the restoration of the chin volume versus a reference product, Juvéderm® Voluma, the restoration of midface, temple, and jaw-line from volumes baseline (D0) to D21 according to a global Aesthetic 6-point scale clinical scoring.

  D21 (21 days after the injections)

Study Arms (4)

Midface zone

OTHER

Injection in the mid-facial areas (split-face). One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded).

Device: Face correction with injectable fillers

Temple

OTHER

Injection in the temples (split-face). One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded).

Device: Face correction with injectable fillers

Jaw-line

OTHER

Injection in the jaw-line areas (split-face). One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded).

Device: Face correction with injectable fillers

Chin

EXPERIMENTAL

The chin will only receive one injection of Art Filler Volume.

Device: Face correction with injectable fillers

Interventions

Face correction with injectable fillers DEVICE

Injection of hyaluronic acid-based fillers

Chin; Jaw-line; Midface zone; Temple

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who had signed a written informed consent
• Man or Woman with an age ≥ 19 years old
• Subject having a Fitzpatrick Phototype I to IV (annex 6)
• Subject having a score of ≥ 2 in Global aesthetic 6-point scale scoring system on at least one area of interest (chin, midface, temples or jaw lines) (annex 1.1)
• Subject having at least one of the following scales by clinical scoring (annex 1.2/1.3/1.4/1.5)
• a grade of 2 or 3 on the ACRS Scale
• a grade of 2 or 3 score on the MMVS Scale
• a grade of 2 or 3 or 4 score on ATHS Scale
• a grade of 2 or 3 score with NCJLS Scale
• Subject registered with health insurance regimen
• Woman agreeing to take a pregnancy test

You may not qualify if:

• Subject deprived of freedom by an administrative or legal decision
• Subject who have received indemnification of 4500 € during the 12 previous months for his/her participation in clinical trials (including his participation in this study).
• Subject who had facial injections/implants of any non-absorbable fillers in her/his whole life.
• Subject who had laser sessions for skin rejuvenation or a laser resurfacing during the 12 previous months or a surgical facelift during the 2 years before the study.
• 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).
• Subject with a skin-retaining device on the face (mesh, gold wire, liquid silicone or other particulate material).
• Subject who undergo a non-invasive rejuvenation method such as moderate to deep peeling, ultrasound, radiofrequency devices or lasers within the last 6 months.
• Subject with a history of severe multiple allergies or anaphylactic shock.
• Subject with a known hypersensitivity to hyaluronic acid, Lidocaine and/or other components of Art Filler® Volume and Juvéderm Voluma solutions.
• Subject with a known hypersensitivity to chlorhexidine.
• Subject with a known hypersensitivity to lidocaine or local amide anesthetics.
• Subject tending to develop inflammatory skin diseases or hypertrophic scars.
• Subject with a history of streptococcal disease (recurring angina, rheumatic fever).
• 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.
• Subjects with any concomitant treatment (or not stopped for at least a year) by immunosuppressant or chemotherapy.

Sponsors & Collaborators

• Laboratoires FILLMED: lead

Study Sites (1)

Dr Frédéric Braccini

Nice, 06000, France

Location

Study Officials

• Ferial FANIAN, MD

  Laboratoires FILLMED

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: During the period of this clinical trial (18 months), only two products will be used for the aesthetic procedures (Art Filler Volume and Juvéderm Voluma). This prospective study will analyze 120 patients maximum who will receive dermal filler injections to the midface, temple, chin and jaw-line (cross-injection is authorized with maximum 2 zones per subject). The injections will be administered in a randomly assigned split-face design, except for the chin. One side of the subject's face will receive Art Filler Volume according to the randomization table, whereas the other side will receive Juvéderm Voluma injections in a blinded manner for the subjects (single blinded). The chin will only receive one injection of Art Filler Volume.

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: May 14, 2019
• Primary Completion: August 2, 2019
• Study Completion: January 25, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)