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The goal of this clinical investigation is to learn whether injectable implants based on non-cross-linked hyaluronic acid (Electri and XELA REDERM) improve the aesthetic appearance of facial skin in adult women. It will also learn about the safety of these medical devices.
The main questions it aims to answer are:
Does skin appearance improve after a series of redermalization procedures? How do the procedures affect skin hydration and elasticity? What side effects or medical issues, if any, do participants experience? Researchers did not use a control group. Instead, they evaluated skin improvements in the same participants over time.
Participants:
Received 3 injections of the hyaluronic acid-based device over 6 weeks (1 injection every 14±1 days).
Had their skin condition assessed by doctors and by themselves using a standardized scale.
Underwent tests to measure skin hydration and elasticity. Reported any adverse events or adverse device effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group: Reder malization with Non-Cross-Linked Hyaluronic Acid (Electri and XELA REDERM) | Experimental | Participants in this single-group arm received a course of three redermalization procedures with injectable implants based on non-cross-linked hyaluronic acid. The investigational medical devices included Electri (0.55%) and XELA REDERM (1.1%, 1.8%, or 2.2%), administered intradermally every 14±1 days as part of routine cosmetology practice. The concentration and application area were selected by the investigator based on individual skin conditions. Skin hydration, elasticity, and aesthetic appearance were assessed at baseline and on Days 14, 28, and 42 using instrumental methods and the GAIS scale. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%) | Device | Injectable implant containing 1.1%, 1.8%, or 2.2% non-cross-linked hyaluronic acid with succinic acid, sodium succinate, sodium chloride, and water for injection. Intended for redermalization to improve skin quality through biorevitalization. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed improvement in facial skin condition using GAIS scale on Day 42 compared to baseline | The investigator evaluated changes in the aesthetic appearance of facial skin using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from -1 ("Worse") to 3 ("Very much improved"). The primary endpoint is the mean GAIS score on Day 42 compared to baseline. | Day 42 ±1 after first injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Provita Sp. z o.o. | Katowice | 40-611 | Poland | |||
| Ośrodek medyczny OSTEOMED s.c. |
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|
| Electri (non-cross-linked hyaluronic acid 0.55%) | Device | Injectable implant containing 0.55% non-cross-linked hyaluronic acid with succinic acid, sodium succinate, sodium chloride, and water for injection. Intended for redermalization aimed at improving skin hydration, elasticity, and appearance. |
|
| Krakow |
| 30-074 |
| Poland |
| Prime Clinic Sp. z o.o. | Warsaw | 00-342 | Poland |
| Institute Hyalual LLC | Kyiv | 03151 | Ukraine |