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

NCT ID: NCT06984432

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2021-10-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%)

Intervention Type: 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%)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute Hyalual GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Poland; Ukraine

Other Identifiers

Reg.Hyal-01

Identifier Type: -

Identifier Source: org_study_id