Completed

RegHyal-01Hyaluronic Acid Implants for Facial Skin Appearance in Adult Women

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

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

+ Electri (non-cross-linked hyaluronic acid 0.55%)

Device
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: March 2021
See protocol details

Summary

Principal SponsorInstitute Hyalual GmbH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 30, 2021

Actual date on which the first participant was enrolled.

The clinical investigation aims to determine if certain injectable treatments can improve the look of facial skin in adult women. The treatments use a substance called non-cross-linked hyaluronic acid, found in products named Electri and XELA REDERM. The study focuses on how these injections might enhance the skin's appearance, including its hydration and elasticity. It is important because finding effective ways to improve skin aesthetics can boost confidence and well-being. Additionally, the study will check the safety of these treatments, ensuring they do not cause harm. Participants receive a total of three injections over a period of six weeks, with each injection spaced about two weeks apart. Doctors and participants themselves evaluate changes in skin conditions using a specific scale. The study also involves tests that measure skin hydration and elasticity to determine improvements. Any side effects or issues with the treatments are recorded to assess safety. This approach helps understand both the benefits and any potential risks associated with using these hyaluronic acid injections for facial skin enhancement.

Official TitleA 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.
NCT06984432
Principal SponsorInstitute Hyalual GmbH
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

77 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Provita Sp. z o.o.

Katowice, PolandOpen Provita Sp. z o.o. in Google Maps
Suspended

Ośrodek medyczny OSTEOMED s.c.

Krakow, Poland
Suspended

Prime Clinic Sp. z o.o.

Warsaw, Poland
Suspended

Institute Hyalual LLC

Kyiv, Ukraine
Completed4 Study Centers
RegHyal-01 | Hyaluronic Acid Implants for Facial Skin Appearance in Adult Women | PatLynk