Evaluation of the Long Term Efficacy and Tolerability of ART FILLER® Volume and Lips

NCT05456971 | Completed

• 1 other identifier: AF2:2016-A00358-43
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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. Art Filler® Volume and Art Filler Lips are two hyaluronic-based fillers. Both contain 0.3% lidocaine hydrochloride for its anaesthetic properties. The difference between the two devices lies in their viscosity, which must be adapted for the regions being treated and to restoring facial volumes. Midface for Art Filler® Volume and Lips for Art filler® Lips. On this background, a study is conducted to evaluate the long term efficacy and tolerability of Art Filler® Volume and Art Filler® Lips. It is a prospective, non-comparative, multicentre study with long term evaluation (18 months) of the tolerability and assessment of the efficacy of two devices containing hyaluronic acid intended for filling of lines and restoring volume to the face and lips.

Conditions

Aging

Outcome Measures

Primary Outcomes (2)

• Volume correction on D21 with Art Filler Volume

  To confirm the capacity of Art Filler Volume to restore a midface volume 3 weeks (D21) after the first injection or after 6 weeks if a touch up was performed at 3 weeks. For a given target area (right or left) volume restoration will be deemed to be satisfactory if the MMVS (Medicis Midface Volume Scale) score falls by at least 1 point compared to the baseline score. (Score 1, Fairly full midface to Score 4, Substantial loss of fullness)

  D21 (21 days after the injections)

• Volume correction on D21 with Art Filler Lips

  To confirm the capacity of the LIPS filler to restored volume of the treated lip 3 weeks (D21) after the first injection or at 6 weeks if a touch up at 3 weeks is performed. For each lip treated (upper or lower), volume restoration will be deemed to be satisfactory if the MLFS (Medicis Lip Fullness Scale) increases by at least 1 point compared to the baseline score. (Score 1, very thin to Score 5, very full)..

  D21 (21 days after the injections)

Secondary Outcomes (5)

• Description of local tolerability and emergent local and general incidents during a maximum follow up period of 18 months.

  18 months (540 Days after the injections)

• Evaluation of persistence of volume-enhancing effect

  18 months (540 Days after the injections)

• Evaluation of overall cosmetic improvement

  18 months (540 Days after the injections)

• Evaluation of the injection procedures

  18 months (540 Days after the injections)

• Evaluation of self-esteem by subjects

  12 months (360 Days after the injections)

Study Arms (2)

Art filler Volume

EXPERIMENTAL

To confirm the capacity of the VOLUME filler to restore a midface volume 3 weeks after the first injection or after 6 weeks if a touch up was performed at 3 weeks.

Device: Art Filler Volume

Art Filler Lips

EXPERIMENTAL

To confirm the capacity of the LIPS filler to restored volume of the treated lip 3 weeks after the first injection or at 6 weeks if a top up at 3 weeks is performed.

Device: Art Filler Lips

Interventions

Art Filler Volume DEVICE

Midface correction with injectable hyaluronic acid based-filler

Art filler Volume

Art Filler Lips DEVICE

Lipscorrection with injectable hyaluronic acid based-filler

Art Filler Lips

Eligibility Criteria

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

You may qualify if:

• Adult subjects not under legal protection who have given their written agreement to take part.
• Men or women, 19 years old or older with no upper limit.
• Fitzpatrick phototype, I, II, III or IV.
• Middle 1/3 of the face (cheeks/cheek pads): Score 3 or 4 (moderate to substantial loss of volume in the middle 1/3 of the face) on Medicis Midface Volume Scale (MMVS) AND/OR Lips: Score of 1 to 2 (very thin to thin lips) on the Medicis Lip Fullness Scale (MLFS)
• Subjects seen at least 12 months after any aesthetic surgery procedure to the face.
• Subjects at least 12 months from any corrective aesthetic facial injection (botulin in toxin or any filling agent) in the study regions, i.e. 1/3 of the midface and peri-oral/lip region.
• Subjects who are members of a social security system.

You may not qualify if:

• Subjects who do not meet the selection criteria.
• Subjects who have received a facial injection/implantation of any non-resorbable filling agent.
• Subjects with skin support devices (tension wires, gold wires or weave) in their face.
• Subjects who have received laser or ultrasound medical treatment, deep chemical peeling or dermabrasion to the face during the previous 3 months or intending to undergo such a treatment to the face during the study.
• Subjects with a known past history of hypertrophic, cheloid or dyschromic scarring.
• Subjects with a past history of multiple severe allergies or anaphylactic shock.
• Subjects with known hypersensitivity to any of the components of the study devices.
• Subjects with porphyria.
• Subjects with a past history of Streptococcal diseases (recurrent pharyngitis, acute articular rheumatic disease).
• Subjects with hepatocellular impairment and coagulation disorders.
• Subjects treated with medicinal products which reduce or inhibit liver metabolism.
• Subjects with any acquired or congenital blood dyscrasia abnormality.
• Subjects with cardiac conduction abnormalities.
• Subjects with an episode of Herpes lesions on the face which have recovered within less than 4 weeks and with a contraindication to oral antiviral preventative treatment.
• Subjects with facial scarring involving the injection regions.

Sponsors & Collaborators

• Laboratoires FILLMED: lead

Study Officials

• Ferial Fanian, MD

  Laboratoires FILLMED

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Throughout the study period (18 months), only two products will be used for the aesthetic procedures (Art Filler® Volume and Art Filler® Lips). 100 subjects will be injected in order to have at least 100 midface regions and 100 lips treated and assessed at 3 or 6 weeks for the primary end point.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: July 13, 2022
• Study Start: September 12, 2016
• Primary Completion: December 29, 2016
• Study Completion: May 30, 2018
• Last Updated: July 13, 2022

Record last verified: 2022-07