Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT06984432
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06984432
Study Brief:
Protocol Section:
NCT06984432