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

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.

Completed

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Key information

Conditions

Appearance of Facial Wrinkles Aesthetic Facial Skin Wrinkles Hydration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Provita Sp. z o.o., Katowice, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Infection or inflammation in the implant injection site.
Pregnancy, lactation.
Subject's intention to undergo procedures involving chemical peels, laser irradiation, botulinum toxin injection or other similar procedures in the injection site within the next 45 days after inclusion in the post-marketing investigation.
Subject underwent procedures involving chemical peels, laser irradiation, botulinum toxin injection or other similar procedures in the injection site within 35 days prior to inclusion in the post-marketing investigation.
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.

Treatment and study plan

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.

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.

Primary outcomes

Investigator-assessed improvement in facial skin condition using GAIS scale on Day 42 compared to baseline

Time frame: Day 42 ±1 after first injection

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.

Sponsors and collaborators

Lead sponsor

Institute Hyalual GmbH

Industry

Registry information

Official study title

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.

Acronym: RegHyal-01

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: May 22, 2025
Registry last updated: Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed