NCT06984432

Evaluation of a Non-cross-linked Hyaluronic Acid Medical Device ("Electri" and "XELA REDERM") for Improving Facial Skin Appearance

A Post-marketing, Prospective, Open-label, Single-group, Multicentre Clinical Investigation to Evaluate the Effectiveness and Safety of a Medical Device Based on Non-cross-linked Hyaluronic Acid in Concentrations of 0.55% ("Electri") and 1.1%, 1.8%, or 2.2% ("XELA REDERM") (Diaco Biofarmaceutici S.r.l., Italy) for Improving the Aesthetic Appearance of Facial Skin.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Institute Hyalual GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Appearance of Facial Wrinkles
• Aesthetic
• Hydration
• Facial Skin Wrinkles

Interventions

Type	Name	Description
DEVICE	XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%)	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.
DEVICE	Electri (non-cross-linked hyaluronic acid 0.55%)	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.

Timeline

• Start date: 2021-03-30
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2025-05-22
• Last updated: 2025-06-05

Locations

4 sites across 2 countries: Poland, Ukraine