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Restylane

Restylane Mechanism of Action

Manufacturer:

Galderma

Distributor:

Forewide
/
DCH Auriga - Healthcare
Full Prescribing Info
Action
Mode of action: Restylane/Restylane Lyft: This product is a filler that adds volume to the tissue, thereby restoring the skin contours or enhancing the lips to the desired level of correction. The volume and the lifting capacity originate from the ability of stabilized hyaluronic acid to bind water.
Restylane Kysse: The product adds volume to the tissue thereby enhancing the lips to the desired level. The volume and lifting capacity originate from the ability of cross-linked hyaluronic acid to bind water.
Restylane Defyne/Restylane Refyne/Restylane Volyme: The product adds volume to the tissue thereby restoring the skin contours of the face to the desired level. The volume and lifting capacity originate from the ability of cross-linked hyaluronic acid to bind water.
Performance: Restylane: In a randomised controlled multicentre study with Restylane for the correction of nasolabial folds, 74% of subjects maintained a clinically significant improvement up to at least 6 months after treatment.
In a prospective, multicentre and evaluator-blinded study with Restylane, subjects were initially treated for correction of both nasolabial folds and randomly assigned to retreatment of one nasolabial fold at 4.5 months and the contralateral fold at 9 months. Results demonstrated initial improvement to be consistent up to 18 months. At 18 months, 97% of subjects were reported with a clinical significant improvement. In an extension phase to the study, subjects had both nasolabial folds treated at study start, i.e. 18 months after initial treatment. Results demonstrated continued improvement up to 36 months. At 36 months, 100% of subjects were reported with a clinical significant improvement.
Results from a randomised controlled multicentre study with Restylane for the correction of nasolabial folds showed 74% of subjects to have a maintained clinically significant improvement 18 months after the initial treatment. The treatment regimen included a retreatment at 9 months.
Restylane Defyne: Two randomized controlled multicentre studies with Restylane Defyne for the correction of moderate to severe nasolabial folds both showed maintained effectiveness for a majority of subjects up to at least 48 weeks after initial treatments. In an open-labelled multicentre study to assess performance and tolerance of Restylane Defyne in facial rejuvenation, most subjects were reported with sustained improvement up to at least 6 months in areas including nasolabial folds, marionette lines, and tear troughs. In another open-labelled multicentre study with Restylane Defyne, subjects were assessed for perception of naturalness during contraction following correction of wrinkles and folds in the lower face. Results showed that 98% of subjects had maintained naturalness for at least up to 6 months.
Restylane Kysse: In a randomized controlled study with Restylane Kysse used for lip injections, the aesthetic improvement was sustained for at least 24 weeks. In another randomized controlled study, aesthetic improvement was demonstrated in both lips in a majority of subjects (≥80.0 %) at Month 6 and in more than a third of subjects (≥39.3 %) at Month 12.
Restylane Lyft: In a controlled multicentre study with Restylane Lyft for the correction of nasolabial folds 79% of the subjects maintained a clinically significant improvement 48 weeks after treatment.
In a controlled multicentre study with Restylane Lyft with lidocaine for cheek augmentation and correction of age-related midface contour deficiencies a significant improvement up to 12 months for the correction of midface deficiencies was demonstrated.
In a randomized controlled 12 months follow-up study, Restylane Lyft and Restylane Lyft with lidocaine were comparable in terms of aesthetic efficacy.
Restylane Refyne: In a randomized controlled multicentre study with Restylane Refyne for correction of moderate nasolabial folds, a majority of subjects maintained a clinically significant improvement up to at least 36 weeks. In another randomized controlled multicentre study with Restylane Refyne for correction of moderate to severe nasolabial folds, effectiveness was maintained up to at least 48 weeks after initial injection. In an open-labelled multicentre study to assess performance and tolerance of Restylane Refyne in facial rejuvenation, most subjects were reported with sustained improvement up to at least 6 months in areas including nasolabial folds, marionette lines, and tear troughs. In another open-labelled multicentre study with Restylane Refyne, subjects were assessed for perception of naturalness during contraction following correction of wrinkles and folds in the lower face. Results showed that 98% of subjects had maintained naturalness for at least up to 6 months.
Restylane Volyme: In an open-labelled multicentre study with Restylane Volyme for full face correction of volume loss, all subjects showed an improvement from baseline in full face volume loss 3 weeks after the last injections, and after 18 months, more than two-thirds were still improved. In another open-labelled multicentre study to assess performance and tolerance of Restylane Volyme in facial rejuvenation, a majority of subjects were reported with maintained cheek volume up to at least 6 months.
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