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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
77
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.
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.
Provita Sp. z o.o.
Katowice, Poland
Ośrodek medyczny OSTEOMED s.c.
Krakow, Poland
Prime Clinic Sp. z o.o.
Warsaw, Poland
Institute Hyalual LLC
Kyiv, Ukraine
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.
Time frame: Day 42 ±1 after first injection
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