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.
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. Primary objective: * Art Filler® Volume: To confirm the capacity of Art Filler® Volume to restore a midface volume 3 weeks 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 Medicis Midface Volume Scale (MMVS) score falls by at least 1 moint compared to the baseline score. * Art Filler® Lips: To confirm the capacity of Art Filler® Lips to restore volume of the treated lip 3 weeks after the first injection or after 6 weeks if a touch-up was performed at 3 weeks. For each lip treated (upper or lower) volume restoration will be deemed to be satisfactory if the Medicis Lip Fullness Scale (MLFS) score falls by at least 1 point compared to the baseline score.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Midface correction with injectable hyaluronic acid based-filler
Lipscorrection with injectable hyaluronic acid based-filler
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)
Time frame: 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)..
Time frame: D21 (21 days after the injections)
Description of local tolerability and emergent local and general incidents during a maximum follow up period of 18 months.
For each visit involving an injection, a descriptive analysis of immediate pain experienced (5 point verbal score completed for each target region treated) and effects detected will be performed. These events will be grouped according to the clinician's own wording, by type of event. They will also be categorised as local or systemic events. Their severity, persistence and causal relationship with the procedure will be described. An overall analysis will also be conducted including all injections administered over the 18 month follow up period. The prevalence of these events will be calculated taking account of the target area for local events.
Time frame: 18 months (540 Days after the injections)
Evaluation of persistence of volume-enhancing effect
The MMVS (Medicis Midface Volume Scale) and MFLS (Medicis Lip Fullness Scale) scores for each region injected measured at 3 weeks or at 6 weeks (if a top up is carried out at 3 weeks) after the first injection will define the optimal cosmetic score for a given target region.
Time frame: 18 months (540 Days after the injections)
Evaluation of overall cosmetic improvement
Overall cosmetic improvement will be reported for the PP (Per Protocol) population at 3/6 weeks and at 3, 6, 9, 12, 15 and 18 months from the Doctor and subject GAIS (Global Aesthetic Improvement Scale).
Time frame: 18 months (540 Days after the injections)
Evaluation of the injection procedures
Description of the procedures and injection volumes of the VOLUME filler and LIPS filler and the technical ease of use of these fillers at each visit involving an injection (for a given visit, the total volume injected will be the sum of the initial injection and any top up at 3 weeks). An overall descriptive analysis will also be conducted taking account of all of the injections administered over the whole follow up period.
Time frame: 18 months (540 Days after the injections)
Evaluation of self-esteem by subjects
The evaluation of self-esteem will be determined by using the ETES scale ( "Echelle toulousaine d'estime de soi"). The overall ETES score will be calculated at 6 and 12 months
Time frame: 12 months (360 Days after the injections)
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