Appearance of Facial WrinklesRegHyal-01NCT06984432
Evaluation of a Non-cross-linked Hyaluronic Acid Medical Device ("Electri" and "XELA REDERM") for Improving Facial Skin Appearance
A study testing XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%) and Electri (non-cross-linked hyaluronic acid 0.55%) in people with Appearance of Facial Wrinkles and Aesthetic, run by Institute Hyalual GmbH at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appearance of Facial Wrinkles, Aesthetic, Hydration
- What is being tested?
- XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%) and Electri (non-cross-linked hyaluronic acid 0.55%)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Mar 2021to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Poland3 sites
Provita Sp. z o.o.
Katowice, 40-611
Ośrodek medyczny OSTEOMED s.c.
Krakow, 30-074
Prime Clinic Sp. z o.o.
Warsaw, 00-342
About this study
Official 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.
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:
Read more
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.
- Being tested
- XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%), Electri (non-cross-linked hyaluronic acid 0.55%)
- Keywords
- facial skin, appearance, hydration, elasticity, XELA REDERM, Electri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%); Device: Electri (non-cross-linked hyaluronic acid 0.55%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 42 ±1 after first injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start30 Mar 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appearance of Facial WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute Hyalual GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984432
- Sponsor's protocol ID
- Reg.Hyal-01
- Acronym
- RegHyal-01
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06984432
- Acronym / sponsor ID
- RegHyal-01 / Reg.Hyal-01
- Keywords
- facial skin, appearance, hydration, elasticity, XELA REDERM, Electri
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Institute Hyalual GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group: Reder malization with Non-Cross-Linked Hyaluronic Acid (Electri and XELA REDERM) | Experimental | Device: XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%), Device: Electri (non-cross-linked hyaluronic acid 0.55%)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Single Group: Reder malization with Non-Cross-Linked Hyaluronic Acid (Electri and XELA REDERM) |
| 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. | Device | Single Group: Reder malization with Non-Cross-Linked Hyaluronic Acid (Electri and XELA REDERM) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
Related trials for Appearance of Facial Wrinkles
Not yet recruitingObservational study
Comparing Facial Aging Between Identical Twins With 3D Imaging
Facial Skin Aging, Facial Volume Loss
Recruiting
Effect of Single Facial Acupuncture on Dermal Structure and Appearance Satisfaction
Facial Aging, Wrinkles
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%) and Electri (non-cross-linked hyaluronic acid 0.55%) in people with Appearance of Facial Wrinkles and Aesthetic, run by Institute Hyalual GmbH at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed improvement in facial skin condition using GAIS scale on Day 42 compared to baseline (time frame: Day 42 ±1 after first injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.