Perioral LinesPhase 3NCT05454033
A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants in China With Fine Lines Around the Mouth
A Phase 3 study testing JUVÉDERM® VOLITE™ in people with Perioral Lines, run by AbbVie at 11 sites in China.
Trial summary
Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many injectable fillers are used to treat facial aging and correct skin defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioral Lines
- What is being tested?
- JUVÉDERM® VOLITE™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 11 sitesChina
- Study dates
- 7 Sep 2022to 3 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Has moderate or severe perioral lines (Perioral Lines at Rest Severity Scale [POLSS] Grades 2 or 3) as assessed by the Evaluating Investigator (EI).
- Participants seeking improvement of lines, hydration, and skin smoothness in perioral area.
- Is able to achieve a 1-point improvement in POLSS score in the judgment of Treating Investigator (TI).
- Participant must be in good health as determined by medical history, vital signs, and TI's judgment, including no known active pandemic infection.
Who cannot join
- Has a history of anaphylaxis, atopy, or allergy to lidocaine, hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
- Has current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, an unhealed wound, angioneurotic edema, cheilitis, or a cancerous or precancerous lesion in the perioral area that could interfere with effectiveness assessments.
- Has a tendency to develop hypertrophic scarring.
- Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
- Has a history of anaphylactic shock.
- Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease) other than Hashimoto's thyroiditis.
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- Has porphyria.
- Has a history of skin cancer.
- Has ever received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) below the subnasale.
- Has ever undergone fat injections or calcium hydroxyapatite below the subnasale.
- Has undergone volume augmentation with semi-permanent soft tissue fillers (e.g., poly-L-lactic acid) within 24 months or temporary soft tissue fillers within 12 months below the subnasale.
- Has undergone treatment with botulinum toxins below the subnasale within 6 months of study entry or is planning to undergo such treatment during the study.
- Has received cosmetic resurfacing below the subnasale within 6 months before enrollment (examples include laser, radiofrequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures) or is planning to undergo such treatment during the study.
- Has received mesotherapy or cosmetic treatments below the subnasale within 3 months before enrollment (e.g., photomodulation, intense pulsed light) or is planning to undergo such treatment during the study.
- Has undergone oral surgery (e.g., tooth extraction, aesthetic restoration of front teeth, or implantation in anterior region) within 30 days before enrollment or is planning to undergo any of these procedures during the study.
- Is undergoing orthodontia before enrollment or is planning to undergo it during the study.
- Has changes in use of over-the-counter or prescription oral anti-wrinkle products or topical products below the subnasale within 30 days before enrollment (participants are not eligible for this study if they have begun using any new over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasale within 30 days before enrollment. Participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study).
- Is on a regimen of anti-coagulation therapy (e.g., warfarin, clopidogrel).
- Is on an ongoing regimen of medications (e.g., aspirin, ibuprofen) or other substances (e.g., herbal supplements with garlic, gingko biloba, or ginseng) known to increase coagulation time within 10 days of undergoing study device injection (study device injection may be delayed as necessary to accommodate this 10-day washout period).
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
- Has tattoos, piercings, or scars that would interfere with visual assessment of the perioral lines.
- At TI's discretion, based on participant's safety and/or study integrity, the participant has a condition or is in a situation that, in the TI's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study, such as clinically significant abnormal lab testing results as judged by TI.
- Directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, or other study staff member; employee of the sponsor; first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or enrolled in the study at another clinical site.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
China-Japan Friendship Hospital /ID# 252139
Beijing, Beijing Municipality, 100029
Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 231394
Beijing, Beijing Municipality, 100144
Beijing Hospital /ID# 231393
Beijing, Beijing Municipality, 100730
West China Hospital, Sichuan University /ID# 231740
Chengdu, Sichuan, 610041
The Third Affiliated Hospital, Sun Yat-Sen University /ID# 231398
Guangzhou, Guangdong, 510630
Hangzhou First People's Hospital /ID# 244111
Hangzhou, Zhejiang, 310003
Nanjing Drum Tower Hospital /ID# 231937
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University /ID# 244045
Nanjing, Jiangsu, 210009
Huashan Hospital, Fudan University /ID# 231395
Shanghai, Shanghai Municipality, 200040
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231396
Wuhan, Hubei, 430022
Peking University First Hospital /ID# 231392
Xicheng District, Beijing Municipality, 100034
About this study
Official title: Multicenter, Evaluator-blind, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLITE™ for Correction of Perioral Lines in Chinese Population
Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many injectable fillers are used to treat facial aging and correct skin defects. In this study, adverse effects and effectiveness of JUVÉDERM® VOLITE™ will be assessed in correcting perioral lines (around the mouth).
VOLITE is an investigational device being developed for the correction of perioral lines. In this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Adult participants seeking improvement of lines, hydration, and skin smoothness in perioral area will be enrolled. Around 198 participants will be enrolled in the study at approximately 12 sites in China.
Read more
Participants in the treatment group will receive the initial injection of VOLITE; the control group will receive no treatment, but will have the opportunity to receive VOLITE after 2 months. Participants will be followed up for 12 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.
- Conditions
- Perioral Lines
- Being tested
- JUVÉDERM® VOLITE™, Control
- Keywords
- Dermal, Dermatology, Aesthetics, Skin Care, Juvederm, Volite, Perioral, Fine Lines, Wrinkles, Frown Lines, Laugh Lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERM® VOLITE™Device
Also called AGN-8015
Injection, intradermal
ControlOther
No-treatment control
| Study group | Role | What they receive |
|---|---|---|
| JUVÉDERM® VOLITE™ | Experimental | Participants in the treatment group will receive a single dose at the study initiation. Participants are eligible for touch up treatment. Receives: Device: JUVÉDERM® VOLITE™ |
| Control - No Treatment | Other | Participants in the control group will receive no treatment. At Month 2, these participants will have the option to receive the treatment. Receives: Device: JUVÉDERM® VOLITE™; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants who achieved at least 1-point improvement from baseline on the Perioral Lines Severity Scale (POLSS)
Responder status based on the Evaluating Investigator's (EI's) live assessment of perioral lines. The POLSS is a 4-point scale from 0 = None, 1 = Mild, 2 = Moderate, to 3 = Severe. An improvement of 1 or more points is an improvement in visibility of perioral lines.
Measured: Up to Month 2
Secondary outcomes (3)
The percentage of participants assessed as "improved" or "much improved" on the Global Aesthetic Improvement Scale (GAIS) by the EI
The Evaluating Investigator (EI) will assess global aesthetic improvement of the perioral area by comparing to frontal and oblique view photographs taken at baseline. The GAIS is a 5-point scale from 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse, to -2 = Much Worse.
Measured: Up to Month 2
The percentage of participants assessed as "improved" or "much improved" on the Global Aesthetic Improvement Scale (GAIS) by the participant
The participant will utilize GAIS to assess global aesthetic improvement of the perioral area by comparing to frontal and oblique view photographs taken at baseline.
Measured: Up to Month 2
The change from baseline on the FACE-Q Appraisal of Lines: Lips questionnaire
The FACE-Q Appraisal of Lines: Lips is a validated scale used to assess the impact of treatment from the participant's perspective. Participants respond to each item on a scale from 1 = Not at all, 2 = A little, 3 = Moderately, to 4 = Extremely.
Measured: Up to Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start7 Sep 2022
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioral LinesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
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
- NCT05454033
- Sponsor's protocol ID
- M21-528
- Status last verified
- Nov 2025
- First submitted
- 8 Jul 2022
- Last updated
- 2 Dec 2025
- 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Evaluator-blind, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLITE™ for Correction of Perioral Lines in Chinese Population
- ClinicalTrials.gov ID
- NCT05454033
- Acronym / sponsor ID
- M21-528
- Conditions
- Perioral Lines
- Keywords
- Dermal, Dermatology, Aesthetics, Skin Care, Juvederm, Volite, Perioral, Fine Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 12 Jul 2022 (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.
Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many injectable fillers are used to treat facial aging and correct skin defects. In this study, adverse effects and effectiveness of JUVÉDERM® VOLITE™ will be assessed in correcting perioral lines (around the mouth).
VOLITE is an investigational device being developed for the correction of perioral lines. In this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Adult participants seeking improvement of lines, hydration, and skin smoothness in perioral area will be enrolled. Around 198 participants will be enrolled in the study at approximately 12 sites in China.
Participants in the treatment group will receive the initial injection of VOLITE; the control group will receive no treatment, but will have the opportunity to receive VOLITE after 2 months. Participants will be followed up for 12 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JUVÉDERM® VOLITE™ | Experimental | Device: JUVÉDERM® VOLITE™Participants in the treatment group will receive a single dose at the study initiation. Participants are eligible for touch up treatment. |
| Control - No Treatment | Other | Device: JUVÉDERM® VOLITE™, Other: ControlParticipants in the control group will receive no treatment. At Month 2, these participants will have the option to receive the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has moderate or severe perioral lines (Perioral Lines at Rest Severity Scale [POLSS] Grades 2 or 3) as assessed by the Evaluating Investigator (EI).
- Participants seeking improvement of lines, hydration, and skin smoothness in perioral area.
- Is able to achieve a 1-point improvement in POLSS score in the judgment of Treating Investigator (TI).
- Participant must be in good health as determined by medical history, vital signs, and TI's judgment, including no known active pandemic infection.
Key exclusion criteria (23 listed)
- Has a history of anaphylaxis, atopy, or allergy to lidocaine, hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
- Has current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, an unhealed wound, angioneurotic edema, cheilitis, or a cancerous or precancerous lesion in the perioral area that could interfere with effectiveness assessments.
- Has a tendency to develop hypertrophic scarring.
- Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
- Has a history of anaphylactic shock.
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 |
|---|---|---|
| JUVÉDERM® VOLITE™Also: AGN-8015Injection, intradermal | Device | Control - No Treatment, JUVÉDERM® VOLITE™ |
| ControlNo-treatment control | Other | Control - No Treatment |
Primary outcome
The percentage of participants who achieved at least 1-point improvement from baseline on the Perioral Lines Severity Scale (POLSS)
Time frame: Up to Month 2
Responder status based on the Evaluating Investigator's (EI's) live assessment of perioral lines. The POLSS is a 4-point scale from 0 = None, 1 = Mild, 2 = Moderate, to 3 = Severe. An improvement of 1 or more points is an improvement in visibility of perioral lines.
3 secondary outcomes
The percentage of participants assessed as "improved" or "much improved" on the Global Aesthetic Improvement Scale (GAIS) by the EI
Time frame: Up to Month 2
The percentage of participants assessed as "improved" or "much improved" on the Global Aesthetic Improvement Scale (GAIS) by the participant
Time frame: Up to Month 2
The change from baseline on the FACE-Q Appraisal of Lines: Lips questionnaire
Time frame: Up to Month 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- 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.
Related trials for Perioral Lines
RecruitingObservational study
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2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
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Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
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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. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
11 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 JUVÉDERM® VOLITE™ in people with Perioral Lines, run by AbbVie at 11 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 4 inclusion and 23 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: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of participants who achieved at least 1-point improvement from baseline on the Perioral Lines Severity Scale (POLSS) (time frame: Up to Month 2). 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 2 Dec 2025.