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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT05622812
Eligibility Criteria:
Inclusion Criteria:
* Male and female adults willing to comply with the requirements of the study and providing a signed written informed consent
* Consent the use of facial images for marketing purposes and educational material
* Subject with moderate to very severe (Grade 2 to 4) on the GJS
* Subject is willing to abstain from any other facial, submental, and/or neck aesthetic procedure(s) or implant
* Female of childbearing potential with a negative urine pregnancy test before treatment
Exclusion Criteria:
* Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid (HA) filler, lidocaine or other amide-type local anesthetics
* Subjects presenting with known/previous allergy or hypersensitivity to streptococcal proteins
* Subject with bleeding disorders or taking thrombolytics or anticoagulants
* Prior surgical procedure in the treatment area
* History of other facial treatment/procedure in the previous 6 months HA in or near the intended treatment site
* Presence of any disease or lesions near or on the area to be treated
* Presence of any condition, in the opinion of the Treating Investigator, makes the subject unable to complete the study per protocol
* Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period
* Study site personnel, close relatives of the study site personnel, employees, or close relatives of employees at the Sponsor Company
* Participation in any other interventional clinical study within 30 days before treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05622812
Study Brief:
Protocol Section:
NCT05622812