Nasolabial FoldsPhase 3NCT07794878
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 Phase 3 study testing NOA LIFT and JUVÉDERM VOLIFT with Lidocaine in people with Nasolabial Folds, run by AbbVie at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- NOA LIFT and JUVÉDERM VOLIFT with Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 6 sitesChina
- Study dates
- 19 Aug 2026to Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Peking Union Medical College Hospital (West) - Xidan Campus /ID# 267457
Beijing, Beijing Municipality, 100032
- Recruiting
Zhujiang Hospital /ID# 276566
Guangzhou, Guangdong, 510280
- Recruiting
Nanjing Drum Tower Hospital /ID# 267555
Nanjing, Jiangsu, 210008
- Recruiting
Zhongda Hospital Of Southeast University /ID# 276571
Nanjing, Jiangsu, 210009
- Recruiting
Peking University Shenzhen Hospital /ID# 268255
Shenzhen, Guangdong, 518036
- Recruiting
Xianyang Hospital of Yanan University /ID# 267936
Xianyang, Shaanxi, 712000
About this study
Official 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
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.
Read more
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
- Being tested
- NOA LIFT, JUVÉDERM VOLIFT with Lidocaine
- Keywords
- Nasolabial Folds, NOA LIFT, JUVÉDERM VOLIFT, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOA LIFTDrug
Injection
JUVÉDERM VOLIFT with LidocaineDrug
Injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: JUVÉDERM VOLIFT with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: Month 6
Percentage of Participants With Responder Status Based on Participant's Assessment of Global Aesthetic Improvement Scale (GAIS) in Nasolabial Folds (NLFs)
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.
Measured: Month 6
Change From Baseline in the Overall Score of FACE-Q - Appraisal of Lines: Nasolabial Folds
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.
Measured: Up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start19 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794878
- Sponsor's protocol ID
- M23-066
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07794878
- Acronym / sponsor ID
- M23-066
- Conditions
- Nasolabial Folds
- Keywords
- Nasolabial Folds, NOA LIFT, JUVÉDERM VOLIFT, Lidocaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOA LIFT | Experimental | Drug: NOA LIFTParticipants 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. |
| JUVÉDERM VOLIFT With Lidocaine | Active comparator | Drug: JUVÉDERM VOLIFT with LidocaineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOA LIFTInjection | Drug | NOA LIFT |
| JUVÉDERM VOLIFT with LidocaineInjection | Drug | JUVÉDERM VOLIFT With Lidocaine |
Primary outcome
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.
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.
3 secondary outcomes
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
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
Change From Baseline in the Overall Score of FACE-Q - Appraisal of Lines: Nasolabial Folds
Time frame: Up to Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NOA LIFT and JUVÉDERM VOLIFT with Lidocaine in people with Nasolabial Folds, run by AbbVie at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Responder Status Based on Evaluating Investigator's Live Assessment of Nasolabial Fold Severity Scale (NLFSS) (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.