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

NCT07794878 | Recruiting Phase 3

• 1 other identifier: M23-066
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Nasolabial Folds

Keywords

Nasolabial Folds; NOA LIFT; JUVÉDERM VOLIFT; Lidocaine

Outcome Measures

Primary Outcomes (2)

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

  The NLFSS is a validated 5-point scale used to assess the severity of nasolabial folds, where higher scores indicate more severe folds.

  Month 6

• Number of Participants With Adverse Events

  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.

  Up to approximately 13 months

Secondary Outcomes (3)

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

  Month 6

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

  Month 6

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

  Up to Month 6

Study Arms (2)

NOA LIFT

EXPERIMENTAL

Participants will receive initial treatment with NOA LIFT injected into the nasolabial folds. Optional touch-up treatment may be administered at Day 31 if optimal aesthetic correction has not been achieved.

Drug: NOA LIFT

JUVÉDERM VOLIFT With Lidocaine

ACTIVE COMPARATOR

Participants will receive initial treatment with JUVÉDERM VOLIFT with Lidocaine injected into the nasolabial folds. Optional touch-up treatment may be administered at Day 31 if optimal aesthetic correction has not been achieved.

Drug: JUVÉDERM VOLIFT with Lidocaine

Interventions

NOA LIFT DRUG

Injection

NOA LIFT

JUVÉDERM VOLIFT with Lidocaine DRUG

Injection

JUVÉDERM VOLIFT With Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (6)

Peking Union Medical College Hospital (West) - Xidan Campus /ID# 267457

Beijing, Beijing Municipality, 100032, China

RECRUITING

Zhujiang Hospital /ID# 276566

Guangzhou, Guangdong, 510280, China

RECRUITING

Peking University Shenzhen Hospital /ID# 268255

Shenzhen, Guangdong, 518036, China

RECRUITING

Nanjing Drum Tower Hospital /ID# 267555

Nanjing, Jiangsu, 210008, China

RECRUITING

Zhongda Hospital Of Southeast University /ID# 276571

Nanjing, Jiangsu, 210009, China

RECRUITING

Xianyang Hospital of Yanan University /ID# 267936

Xianyang, Shaanxi, 712000, China

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: August 31, 2026
• Study Start: August 19, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CN (6)