RegHyal-01Hyaluronic Acid Implants for Facial Skin Appearance in Adult Women
XELA REDERM (non-cross-linked hyaluronic acid 1.1%, 1.8%, or 2.2%)
+ Electri (non-cross-linked hyaluronic acid 0.55%)
Other Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.77 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Ośrodek medyczny OSTEOMED s.c.
Krakow, PolandPrime Clinic Sp. z o.o.
Warsaw, PolandInstitute Hyalual LLC
Kyiv, Ukraine