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

Condition(s) studied

Investigational drug(s) / intervention(s)

NOA LIFT: Injection

JUVÉDERM VOLIFT with Lidocaine: Injection

Study summary

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.

Eligibility

Primary outcome measure(s)

• Percentage of Participants With Responder Status Based on Evaluating Investigator's Live Assessment of Nasolabial Fold Severity Scale (NLFSS) — Month 6
  The NLFSS is a validated 5-point scale used to assess the severity of nasolabial folds, where higher scores indicate more severe folds.
• Number of Participants With Adverse Events — Up to approximately 13 months
  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Trial sites (6)

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