Safety and Effectiveness of ELLANSÉ®-S Dermal Filler in the Treatment of Nasolabial Folds

Inclusion Criteria:

Only subjects meeting all of the following inclusion criteria will be considered for study enrollment:

1. Subject is male or female aged at least 22 years.

2. Subject has bilateral moderate or severe (symmetric grade 3 or 4) NLFs on the WSRSas scored by the treating investigator.

3. Subject is willing to abstain from other facial aesthetic procedures in the lowerface including the NLFs through the study period (up to the final follow-up visit,depending on retreatment) which could interfere with treatment outcomes (e.g. facialfillers, skin laser and radiofrequency therapy such as Thermage, chemicalre-surfacing, dermabrasion, Botox injections, aesthetic facial surgery, other facialtreatments in the NLFs).

4. Subject understands and accepts the obligation to present for all scheduledfollow-up visits and is logistically able to meet all study requirements.

5. Subject with facial hair which may obstruct the assessment of the treatment area,must be agreeable with non-laser removal of facial hair prior to assessment visits.

6. Subject agrees to avoid dental procedures (surgery, implants, dental work) for 3weeks after any treatment.

7. Subject is willing to provide written informed consent for their participation inthe study.

8. Subject has best corrected visual acuity of 20/40 or better (in each eye), and havenormal confrontational visual fields, and normal extraocular motility.

Exclusion Criteria:

Subjects having any of the following criteria, either at screening or at baseline, will not be included in the study:

1. Subject is a female of childbearing potential (e.g., not postmenopausal for at leastone year or has not had a hysterectomy or tubal ligation) not using medicallyeffective birth control (e.g., hormonal methods in use at least 30 days prior toinjection or barrier methods such as condom and spermicide in use at least 14 daysprior to injection) or is pregnant, lactating, or plans to become pregnant duringthe study.

2. Subject has participated in a clinical study in which an investigational device ordrug was received in the 30 days prior to screening or plans to enroll in such astudy during the course of the current study.

3. Subject is an employee or direct relative of an employee of the investigational siteor study sponsor.

4. Subject has received surgery in the NLFs.

5. Subject has received facial threads or autologous fat injections in the face.

6. Subject has a serious or progressive disease, which, in the investigator's judgment,puts the subject at undue risk (e.g., uncontrolled diabetes, autoimmune disease,cardiac pathologies).

7. Subject has an acute inflammatory process or infection, or history of chronic orrecurrent infection or inflammation with the potential to interfere with the studyresults or increase the risk of adverse events.

8. Subject has a disorder that may impact wound healing such as connective tissue orimmunosuppressive disorder.

9. Subject has a history of precancerous lesions/skin malignancies.

10. Subject has had an active skin disease within the past 6 months.

11. Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology inthe NLFs that in the Investigator's opinion will affect evaluation or treatment.

12. Subject has facial hair covering the nasolabial folds that they are unwilling toremove for study assessments.

13. Subject has a past history of systemic streptococcal disease or an activestreptococcus infection.

14. Subject has had a COVID-19 vaccine within 2 weeks of scheduled injections or plansto receive one 3 weeks after any study injection.

15. Subject was ill with a virus (SARS, COVID, flu) within 2 weeks of scheduledinjection.

16. Subject is predisposed to keloidosis or hypertrophic scarring.

17. Subject has a known history of hyper- or hypo-pigmentation in the NLFs.

18. Subject with known allergy to poly (ε-caprolactone), phosphate buffered saline,glycerine, calcium hydroxylapatite (CaHA), or sodium carboxymethylcellulose.

19. Subject has a known history of multiple allergies, allergic/anaphylactic reactionsincluding hypersensitivity to lidocaine or anesthetics of the amide type.

20. Subject has a known bleeding disorder.

21. Subject has received within the past 2 weeks or plans to receive up to 1 week aftertreatment high-dose Vitamin E, aspirin, anti-inflammatories, antiplatelets,thrombolytics or any other medication that could increase the risk of bleeding.

22. Subject has received any medication which, in the judgement of the investigator, mayinterfere with the study objectives.

23. Subject has received within the past 12 months or plans to receive during the studyany injections outside of those in the study protocol including non-permanentfillers (e.g., hyaluronic acid) or neurotoxin on the face below cheekbone (foreheadis acceptable).

24. Subject has received at any time or plans to receive during the study a permanentfiller (e.g., PMMA, silicone) on the face below the cheekbone.

25. Subject has received within the past 24 months or plans to receive during the studya semi-permanent or long last filler (e.g. polylactic acid or calciumhydroxylapatite CaHA) on the face.

26. Subject has received within the past 6 months or plans to receive during the studydermal resurfacing procedures or non-invasive skin tightening or energy based ormechanical or chemical aesthetic procedure on the face.

27. Subject has received in the past 4 weeks or plans to receive during the studyprescription facial wrinkle therapies (tretinoin), topical steroids,

28. Subject has received within the past 2 weeks skin irritating topical preparations,or self-tanning agents on the face.

29. Subject has received within the past 6 months systemic retinoids.

30. Subject has received within the past 3 months systemic steroids or chemotherapy orimmunosuppressive agents.

31. Subject has a known history of ongoing rapid weight loss/gain or plans to begin aweight loss program during the study (5% of body weight).