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NCT Number: NCT07794878

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

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.

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Key information

Conditions

Nasolabial Folds

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital (West) - Xidan Campus /ID# 267457, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NOA LIFT

Drug

Injection

JUVÉDERM VOLIFT with Lidocaine

Drug

Injection

Primary outcomes

  1. Percentage of Participants With Responder Status Based on Evaluating Investigator's Live Assessment of Nasolabial Fold Severity Scale (NLFSS)

    Time frame: 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.

  2. Number of Participants With Adverse Events

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants With Responder Status Based on Evaluating Investigator's Assessment of Global Aesthetic Improvement Scale (GAIS) in Nasolabial Folds (NLFs)

    Time frame: Month 6

    A responder is defined as a participant with improvement in the GAIS in NLF (defined as improved or much improved in GAIS). The GAIS is used to assess aesthetic improvement, with higher ratings indicating greater improvement.

  2. Percentage of Participants With Responder Status Based on Participant's Assessment of Global Aesthetic Improvement Scale (GAIS) in Nasolabial Folds (NLFs)

    Time frame: Month 6

    A responder is defined as a participant with improvement in the GAIS in NLF (defined as improved or much improved in GAIS). The GAIS is used by participants to assess their own aesthetic improvement, with higher ratings indicating greater improvement.

  3. Change From Baseline in the Overall Score of FACE-Q - Appraisal of Lines: Nasolabial Folds

    Time frame: Up to Month 6

    The FACE-Q - Appraisal of Lines: Nasolabial Folds is a patient-reported outcome measure assessing satisfaction with nasolabial fold appearance. Higher scores indicate better outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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