Status:
COMPLETED
Evaluation of a Non-cross-linked Hyaluronic Acid Medical Device ("Electri" and "XELA REDERM") for Improving Facial Skin Appearance
Lead Sponsor:
Institute Hyalual GmbH
Conditions:
Appearance of Facial Wrinkles
Aesthetic
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2021
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT06984432
Start Date
March 30 2021
End Date
October 29 2021
Last Update
June 5 2025
Active Locations (4)
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1
Provita Sp. z o.o.
Katowice, Poland, 40-611
2
Ośrodek medyczny OSTEOMED s.c.
Krakow, Poland, 30-074
3
Prime Clinic Sp. z o.o.
Warsaw, Poland, 00-342
4
Institute Hyalual LLC
Kyiv, Ukraine, 03151