Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Teoxane SA
Age
22–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Outpatient, male or female of any race, 22 years of age or older.
Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
Moderate to severe bilateral nasolabial folds (grade 3 or 4 on the five-point NLF-WSRS). BLE and TI must independently agree that the criterion is met; however, strict concordance of severity not required. BLE assessments will be used for the primary endpoint. If TI and BLE do not agree on eligibility, or if their assessments differ by ≥2 grades, the subject will not be eligible.
Nasolabial folds of the same NLF-WSRS grade on the left and right sides of the face.
Willing to abstain from facial aesthetic procedures/therapies that could interfere with the study evaluations.
Able to follow study instructions and complete all required visits.
Sign the IRB-approved ICF, Photographic Release Form, the Authorization for Use and release of Health and Research Study Information (HIPAA) form, and if applicable, the California Experimental Research Subject's Bill of Rights prior to any study-related procedures being performed.
You may not be if
Known hypersensitivity or previous allergic reaction to any component of the study devices.
Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
History of connective tissue disease.
Malignancy (excluding non-melanoma skin cancer) within the past 5 years.
History of skin cancer in the treatment area.
Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
Exposure to any other investigational drug/device within 90 days of entering the study or planning to participate in another investigation during the course of the study.
Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse)
