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This is a post-marketing, open-label, non-comparative, multi-center clinical investigation to evaluate the effectiveness and safety of the medical device "Alexa Volume" (DIACO BIOFARMACEUTICI S.r.l., Italy), based on cross-linked hyaluronic acid, for the correction of midface volume loss. The study involved 68 female subjects across Poland and Ukraine who received Alexa Volume injections in the midface area. Effectiveness was assessed using the Global Aesthetic Improvement Scale (GAIS), Wrinkle Severity Rating Scale (WSRS), and Medicis Midface Volume Scale (MMVS). The study demonstrated statistically significant improvements in aesthetic outcomes and confirmed a favorable safety profile with minimal adverse events
This clinical investigation evaluated the effectiveness and safety of the CE-marked medical device "Alexa Volume," a cross-linked hyaluronic acid filler, for correction of midface volume loss in adult subjects. Conducted at multiple centers in Poland and Ukraine, the open-label, non-comparative study collected post-marketing data under routine clinical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alexa Volume Treatment Arm | Experimental | Participants in this single treatment arm received subcutaneous or upper-periosteal injections of Alexa Volume, a CE-marked cross-linked hyaluronic acid gel, for the correction of midface volume loss. The initial injection was administered at Visit 1, with an optional additional correction at Visit 2 based on the Investigator's assessment. Effectiveness and safety evaluations were conducted through Visit 4 (Day 180). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cross-linked hyaluronic acid dermal filler | Device | Alexa Volume is a CE-marked, cross-linked hyaluronic acid dermal filler used for aesthetic correction of midface volume loss. It was administered subcutaneously or to the upper periosteum in adult female participants according to standardized procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-evaluated change in midface volume using the Global Aesthetic Improvement Scale (GAIS) from baseline (Visit 1) to Day 28 (Visit 3). | The GAIS (Global Aesthetic Improvement Scale) is a 5-point ordinal scale used to assess improvement in facial aesthetics. The scale ranges from 1 (Very Much Improved) to 5 (Worse), where lower scores indicate better outcomes. Investigators evaluated standardized photographs taken before and after treatment. A reduction of ≥1 point from baseline was considered a clinically meaningful improvement. | 28 days (from baseline Visit 1 to Visit 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silmedic Sp. z o.o. | Katowice | 40-282 | Poland | |||
| Provita Sp. z o.o. |
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This was a non-comparative, open-label study where all subjects received subcutaneous or upper-periosteal injections of Alexa Volume according to standardized procedures under routine clinical (cosmetology) conditions. No control or placebo group was included, and all participants were followed over 180 days for aesthetic and safety outcomes.
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| Katowice |
| 40-611 |
| Poland |
| Ośrodek Medyczny Osteomed s.c. | Krakow | 30-074 | Poland |
| Institute Hyalual LLC | Kyiv | 03151 | Ukraine |