New lip filler study aims to confirm safety and results

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults ≥18 years, males and females. 2. Able and willing to give written informed consent for participation in the investigation. 3. Treating investigator considers the subject's lips amenable to an improvement of at least 1 grade on the GAIS. At least one lip should either have a potential to change (augmentation, contouring or both) or have moderate to severe volume deficit. The grades do not have to be the same on both lips. 4. Ability to follow study instructions and likely to complete all required visits. Exclusion Criteria: 1. Pregnant or lactating females. 2. Any previous hypersensitivity reaction to any constituent of the Investigational medical device (IMD) or to local anaesthetic products. 3. Performed or planned surgery below the nose, permanent implant, injection with fat, and deoxycholic acid that may confound the evaluation of safety and performance of the IMD. 4. Any other intradermal injection, such as semi-permanent fillers or botulinum toxins (no complications are allowed), received in the same injection area within 9 months of the Treatment visit (Visit 1) that may confound the evaluation of safety and performance of the IMD. 5. Has an ongoing episode/relapse, recently diagnosed or newly started medication of an autoimmune disease, as judged by the investigator. 6. Has any chronic or acute skin disease or inflammation (such as pimples, rashes, or hives) within or close to the treatment area. 7. Has any treatments (thrombolytics, anticoagulants etc) or disease related to the coagulation system. 8. Subjects that have taken any type of vaccine within two weeks prior injection with the IMD. 9. Subjects receiving interferon and ribavirin treatment. 10. Features that may interfere with the visual assessment such as recent cosmetic treatment, scarring, abscess, piercing or tattoo below the nose. 11. Participation in a clinical investigation that may affect the safety or performance of this investigation, as judged by the Principal Investigator, or authorized designee. 12. Employees of the study site or the sponsor directly involved with the conduct of the investigation