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:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT03650218
Eligibility Criteria:
Inclusion Criteria:
* Females of childbearing potential must have a negative urine pregnancy test at Screening/ Baseline visit and must agree to use an adequate method of contraception for the duration of the clinical investigation
* Signed informed consent
* Moderate to severe nasolabial folds (cohort 2)
* Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evolution (cohort 2)
* Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
Exclusion Criteria:
* For females: pregnant and/ or lactating or planning to become pregnant during the investigation
* History of allergies or hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-basede anesthetic
* Tendency to keloid formation and/ or hypertrophic scars
* Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated
* Recurrent herpes simplex in the treatment area
* History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy
* Diabetes mellitus or uncontrolled systemic diseases
* History of bleeding disorder and/ or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post-injection
* Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the investigator
* Previous enrollment in this clinical investigation
* Current participation in another clinical investigation, or treatment with any investigational drug/ medical device within 30 days prior to clinical investigation enrollment, or five half-lives of the investigational drug, whichever is longer
* Any dependency of the subject to the investigator or investigation site, or subjects who are employees or relatives of the investigator
* Subjects whose participation in clinical investigations is prohibited by the Austrian Medical Devices Act
* Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance in the area of device application (cohort 2)
* Implantation of facial dermal fillers in the treatment area in the preceding 12 months (cohort 2)
* Skin of the nasolabial region affected by aesthetic treatments or planning to undergo such procedures during the clinical investigation (cohort 2)
* Facial lipolysis, including submental fat treatments within last month prior to enrollment or planned during the clinical investigation (cohort 2)
* Bariatric surgery within 12 months prior to enrollment or planned during the clinical investigation (cohort 2)
* Planned dental/ oral surgery or modification within two weeks prior to injection and to a minimum of four weeks post injection (cohort 2)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03650218
Study Brief:
Protocol Section:
NCT03650218