Study to Assess Adverse Events and How Effective NOA LIFT is Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds in Adults

A Prospective Multi-Center, Evaluator- and Subject- Blinded, Randomized Study to Evaluate the Safety and Effectiveness of NOA LIFT Compared to JUVÉDERM VOLIFT With Lidocaine for the Correction of Nasolabial Folds

Nasolabial folds (NLFs) are wrinkles that run from the sides of the nose to the corners of the mouth. The goal of this study is to evaluate how safe and effective NOA LIFT is compared to JUVÉDERM VOLIFT with Lidocaine for correcting moderate to severe nasolabial folds in adults.

NOA LIFT and JUVÉDERM VOLIFT with Lidocaine are hyaluronic acid-based dermal fillers being evaluated for the treatment of nasolabial folds. Participants are randomly placed into 1 of 2 treatment groups. There is a 2 in 3 chance that participants will be assigned to the NOA LIFT group and a 1 in 3 chance of being assigned to the VOLIFT group. Around 288 adult participants with moderate to severe nasolabial folds will be enrolled at multiple sites in China.

Participants will receive deep dermis injections of either NOA LIFT or JUVÉDERM VOLIFT. The study duration is approximately 12 months after the initial treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, vital signs, laboratory tests, vision assessments, checking for side effects, and completing questionnaires.

Inclusion Criteria:

- Moderate (2) or Severe (3) on the 5-point Nasolabial Fold Severity Scale (NLFSS) for each nasolabial fold (NLF) on evaluator live assessment (both sides must qualify and have the same score)

Exclusion Criteria:

• Current cutaneous or mucosal inflammatory or infectious processes, abscess, unhealed wound, or cancerous or precancerous lesion in the treatment area(s).
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days before enrollment.