Inclusion Criteria
1. Male or female of any race, 22 years of age or older, who are seeking therapy for correction of moderate to severe NLFs. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study.
2. Moderate to severe bilateral NLFs with a severity grading of 3 or 4 as per the Wrinkle Severity Rating Scale (WSRS). Each NLF must have the same WSRS grade.
3. Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations.
4. Able to follow study instructions and complete all required visits.
5. Signed ICF, Photographic Release, HIPAA, and if applicable the California Experimental Research Subject's Bill of Rights.
Exclusion Criteria
1. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable contraception.
2. A condition or situation that puts the subject at significant risk, may confound the study results, or may significantly interfere with subjects' study participation.
3. Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse).
4. Abnormal visual tests (i.e., Snellen acuity test worse than 20/40 with corrections, if applicable), abnormal confrontational visual field test, and/or abnormal ocular motility test.
5. Subjects with known prolonged bleeding times due to disease or anticoagulants (e.g., warfarin). If on a drug or supplement that prolongs bleeding times (e.g., non-steroidal anti-inflammatory, anticoagulant, high-dose vitamin E, fish oil, corticosteroids), wait 7 days or until bleeding times return to normal before injecting. (Note: low dose 81mg/day ASA is permitted).
6. Acute or chronic skin disease, inflammation, or related conditions, cancerous or precancerous lesions near the treatment area.
7. Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to study treatment, or require interfering topical, systemic or surgical therapy.
8. Herpes simplex lesion flare-ups greater than 6 per year.
9. Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with interpretation of study results or compliance of the subject and could make the subject inappropriate for study entry.
10. Known history of allergic/anaphylactic reactions to any of the components of CelluJuve® including known sensitivity to cellulose or local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
11. Malignancy (excluding non-melanoma skin cancer) within the past 3 years.
12. History of systemic granulomatous diseases active or inactive (e.g., Sarcoid, Wegener's disease, TB, etc.) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.).
13. History or evidence of keloid scarring, susceptibility to keloid formation or hypertrophic scarring, or delayed healing activity.
14. History or presence of severe chronic systemic diseases, including but not limited to, poorly controlled diabetes mellitus (all types), congestive heart failure, severe liver disease, severe kidney disease, and others as judged by the Investigator.
15. History or presence of any autoimmune or connective tissue disease, receiving treatment with immunomodulating therapy, or is immunocompromised or immunosuppressed.
16. Known history of clinically significant skin pigmentation disorders.
17. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
18. Elective, clinically significant facial procedures that may confound the interpretation of the results in the NLF area (PI discretion), prior to study enrollment.
19. Physical attribute that may interfere with NLF assessment or treatment (e.g., facial hair, acne scarring, etc.).
20. Received a COVID-19 vaccine within 2 weeks of study entry.
21. Undergoing, or planning to undergo, radiation or ultrasound therapy in the treatment area.
22. History of any previous injectable filler to the study treatment area.
23. Exposure to any other investigational drug/device within 90 days of study entry or planning to participate in another investigation during the course of the study.
