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The purpose of the study is to evaluate the safety and efficacy of Restylane Vital White administered with an injector device on aged skin in the face, hands and décolletage.
The objectives are to explore the safety and efficacy profile of Restylane Vital White administered with an injector device when one side of the face, one of the hands and one side of the décolletage is treated and the other side of the face, the other hand and the other side of the décolletage is left untreated. The face, the hands and the décolletage will be evaluated separately for both the efficacy and the safety parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Untreated | Other |
| |
| Restylane Vital Light | Active Comparator | Restylane Vital Light administered at 3 treatment sessions 4 weeks apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Vital Light | Device | Treatment of up to 4 ml for one side of the face, one hand and one side of the décolletage dispensed by 10ul doses 0.5-1 cm apart. 3 treatment sessions 4 weeks apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Elasticity | To evaluate the change in elasticity from baseline for the treated and untreated side respectively. | 0,4,8,12,20,28,36 weeks |
| GEIS subject | To evaluate esthetic change from baseline as judged by the subjects using GEIS for the treated and untreated side respectively | 4,8,12,20,28,36 weeks |
| GEIS blinded evaluator | To evaluate esthetic change from baseline as judged by the blinded evaluator using GEIS for the treated and untreated side respectively, | 12,20,28,36 weeks |
| Skin structure | To evaluate the change in skin structure from baseline for the treated and untreated side respectively. | 0,4,8,12,20,28,36 weeks |
| Subject satisfaction | To evaluate subject satisfaction | 0,12,20,28,36 weeks |
| Best skin quality by blinded live evaluation | To evaluate best skin quality of treated and untreated side judged by a blinded live evaluation | 12,20,28,36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | To evaluate the safety of Restylane Vital White during the whole study by collecting Adverse Events | 0-36 weeks |
| Subject diary | To evaluate the acute safety profile, i.e. treatment procedure reactions by direct questioning to subjects in a diary used daily for 2 weeks after each injection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martina Kerscher, Professor | University of Hamburg, Prof. Dr. Martina Kerscher, Department Chemie, Martin-Luther-King Platz 6, 20146 Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hamburg | Hamburg | 20146 | Germany |
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|
| No treatment | Other | One side of face, one hand and one side of the décolletage is left untreated as a control. |
|
| 2 weeks after each treatment |