Aging Clinical Trial
Official title:
Evaluation of the Long Term Efficacy and Tolerability of ART FILLER® Volume and Lips, 2 Fillers Containing Hyaluronic Acid. Study ART FILLER 2
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. ;
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