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

NCT06984432 | Completed

• 1 other identifier: Reg.Hyal-01
• Study Type: interventional
• Target: 77
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

facial skin; appearance; hydration; elasticity; XELA REDERM; Electri

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%); Device: Electri (non-cross-linked hyaluronic acid 0.55%)

Interventions

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.

Single Group: Reder malization with Non-Cross-Linked Hyaluronic Acid (Electri and XELA REDERM)

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.

Single Group: Reder malization with Non-Cross-Linked Hyaluronic Acid (Electri and XELA REDERM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject agreed to participate in the Investigation and signed the Informed Consent Form.
• Age over 18 years.
• The subject is eager to undergo a course of skin redermalization procedures using the medical device(devices) 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) in Poland; in concentrations of 1.1%, 1.8% or 2.2% ("XELA REDERM") (Diaco Biofarmaceutici S. r. l., Italy) in Ukraine.
• Female subject confirm that she is not pregnant or lactating during the study.

You may not qualify if:

• Infection or inflammation in the implant injection site.
• Pregnancy, lactation.
• Chronic or acute severe or decompensated visceral diseases.
• Known hypersensitivity to hyaluronic acid, its metabolites, or to the excipients of the injectable implant.
• Known hypersensitivity to analgesics.
• Subject took significant doses of vitamin E, NSAIDs or anticoagulants during the last 7 days.
• Refusal or suspected inability of the subject to comply with the requirements of the CIP.
• Subject has difficulty in understanding the language in which the informed consent is written.
• Any other reason that, in the opinion of the investigator, prevents the subject from participating in the post-marketing investigation.
• Subject takes participation in other clinical investigation.

Sponsors & Collaborators

• Institute Hyalual GmbH: lead

Study Sites (4)

Provita Sp. z o.o.

Katowice, 40-611, Poland

Location

Ośrodek medyczny OSTEOMED s.c.

Krakow, 30-074, Poland

Location

Prime Clinic Sp. z o.o.

Warsaw, 00-342, Poland

Location

Institute Hyalual LLC

Kyiv, 03151, Ukraine

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: March 30, 2021
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

PL (3); UA (1)