Evaluation of the Long Term Efficacy and Tolerability of ART FILLER® Volume and Lips (NCT05456971) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Long Term Efficacy and Tolerability of ART FILLER® Volume and Lips
104 participantsStarted 2016-09-12
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Subjects who do not meet the selection criteria.
. Subjects participating in any other clinical study on the assessment of medicinal products or medical devices or subjects who are in the exclusion period following a clinical study.
✕. 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.