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Aim of the study is to evaluate the re-volumizing performance and the duration effect of the product Aliaxin (new trademark) in women aged 40-65 years with midface volume defects due to aging mechanism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliaxin (new trademark - IBSA Farmaceutici Italia S.r.l.) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliaxin (new trademark - IBSA Farmaceutici Italia S.r.l.) | Device | First treatment was performed during baseline visit, after the basal evaluations planned by the study procedure. 0.5-1.1 ml of Aliaxin (new trademark) for emi-face was injected by needle (25-27 G) and/or cannula (25 G, 40 mm). A touch-up treatment (0.5-1.1 ml of Aliaxin new trademark for subject) was performed after 3-4 weeks (T1) in order to treat possible asymmetry. |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Severity Rating Scale (WSRS) grade variation | Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where:
| Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5) |
| Facial Volume Loss Scale (FVLS) grade variation | Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where:
| Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5) |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic documentation (3D pictures) | Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system. | Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DERMING | Milan | MI | 20900 | Italy |
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| Face volume variation | Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software | Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5) |