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Restylane® Skinboosters™ Vital (SBV) is a smooth formulation without particles, which helps it distribute evenly and smoothly under the skin to aid in rejuvenation. This feature makes RSV particularly well suited for more superficial injections, such as at the level of the dermis.
SBV smooths fine lines and wrinkles and is intended to improve skin smoothness and appearance, as well as the elasticity and hydration of the skin in the face and dorsal hands. However, many clinicians have used SBV in other regions of the body. Given these attributes, SBV are particularly well suited for photo aged skin. A region that is susceptible to photo-ageing and may therefore benefit from the use of SBV is the décolletage. Photodamaged skin of the chest is characterized by atrophy, skin laxity, fine lines and wrinkles, dehydration and tactile roughness. Therefore, SBV may help to improve these signs of aging in the décolletage region.
Study Aim: To investigate the effectiveness and tolerability of SBV for rejuvenation of the décolletage region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane® Skinboosters™ Vital (SBV) | Device | Hyaluronic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Galderma Décolletage Scale | Proportion of subjects achieving at least a one-point improvement on the Galderma Décolletage Scale (GDS), one month following the treatment regime (i.e., Visit 4; Week 12; one month after completing three treatments, each spaced one month apart). Scores: 0 (none) to 4 (severe) | Visit 4, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Galderma Décolletage Scale | Proportion of subjects achieving at least a one-point improvement on the Galderma Décolletage Scale , at Visits 5 and 6 (i.e., 2- and 3-months post treatment regime). Scores: 0 (non) to 4 (severe) | Visit 5 and 6 (Weeks 16 and 20) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Nikolis, FRCSC | Erevna Innovations Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erevna Innovations Inc | Montreal | Quebec | H3R 3A1 | Canada |
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