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

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:

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.

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.