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

NCT06984432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-06-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Institute Hyalual GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2021-10-29
Completion
2021-10-29

Countries

  • Poland
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06984432 on ClinicalTrials.gov