Skin Quality DeficitPhase 2/3NCT06547125
A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants For the Improvement of Skin Quality
A Phase 2/3 study testing JUVÉDERM® VOLITE™ in people with Skin Quality Deficit, run by AbbVie at 6 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
- Skin Quality Deficit
- 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
- 135 participants
- Where
- 6 sitesChina
- Study dates
- 18 Jul 2024to 5 Feb 2026
- Phase
- Phase 2/3
- 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
- Fitzpatrick skin types II-IV
- Participants' FACE-Q Satisfaction with Skin Scale scores must meet the following criteria:
- Participants must have FACE-Q Satisfaction with Skin Scale sum of raw scores of 39 or less
- Participants must score "Very Dissatisfied" or "Somewhat Dissatisfied" on the following two questions:
- How hydrated your facial skin looks?
- How radiant your facial skin looks?
Who cannot join
- Any skin condition in the face area that might not be suitable for injection
- Uncontrolled systemic disease
- History of anaphylactic shock, or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study
- Active autoimmune disease
- Tendency to develop hypertrophic scarring
- Currently undergoing chemotherapy/radiotherapy
- Is undergoing orthodontia before enrollment or is planning to undergo it during the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
China-Japan Friendship Hospital /ID# 260959
Beijing, Beijing Municipality, 100029
Hangzhou First People's Hospital /ID# 260952
Hangzhou, Zhejiang, 310003
Nanjing Drum Tower Hospital /ID# 260950
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University /ID# 260951
Nanjing, Jiangsu, 210009
Huashan Hospital, Fudan University /ID# 261582
Shanghai, Shanghai Municipality, 200040
Peking University First Hospital /ID# 260957
Xicheng District, Beijing Municipality, 100034
About this study
Official title: Multicenter, Evaluator-Blinded, Randomized, No-Treatment Controlled Study of the Effectiveness and Safety of JUVÉDERM® VOLITE™ Injectable Gel for the Improvement in Skin Quality
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 the treatment of fine lines and improving skin quality.
VOLITE is an investigational device being developed for improving skin quality. 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 skin quality, especially hydration and radiance, in the treatment area will be enrolled. Around 135 participants will be enrolled in the study at approximately 6 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 regular 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
- Skin Quality Deficit
- Being tested
- JUVÉDERM® VOLITE™, Control
- Keywords
- Skin Quality Deficit, Juvederm Volite, AGN-8015
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.
Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) Live Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area Using the Global Aesthetic Improvement Scale (GAIS)
A "responder" is a participant who shows improvement in the overall aesthetic assessment on the treatment area using GAIS. GAIS is a 5-point scale ranging from 'Very Much Improved' to 'Worse'.
Measured: Month 2
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in participants, users, or other persons, whether or not related to the investigational medical device, and whether anticipated or unanticipated.
Measured: Up to approximately Month 12
Secondary outcomes (7)
Percentage of Participants Achieving "Responder" Status for Participant's Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area using GAIS
A "responder" is a participant who shows improvement in the overall aesthetic assessment in the treatment area using GAIS. GAIS is a 5-point scale ranging from 'Very Much Improved' to 'Worse'.
Measured: Month 2
Percentage of Participants Achieving "Responder" Status for Treating Investigator's (TI) Assessment of Global Aesthetic Improvement of Skin Quality on the Treatment Area using GAIS
A "responder" is a participant who shows improvement in the overall aesthetic assessment in the treatment area using GAIS. GAIS is a 5-point scale ranging from 'Very Much Improved' to 'Worse'.
Measured: Month 2
Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Scale
The FACE Q Satisfaction with Skin is a validated 12-item scale that asks subjects to report their level of satisfaction with how their facial skin looked "in the past week." Response options are on a 4-point Likert scale ranging from Very dissatisfied to Very Satisfied. Total score is Rasch transformed from 0 (worst) to 100 (best).
Measured: Month 2
Percentage of Participants with Responder Status based on EI's Live Assessments of Hydration Improvement on the Treatment Area Using the Aesthetic Improvement Scale for Hydration
A "responder" is a participant who shows aesthetic improvement in hydration of the treatment area ("Improved," "Much Improved," or "Very Much Improved" on the scale).
Measured: Month 2
Percentage of Participants with Responder Status based on EI's Live Assessments of Radiance Improvement on the Treatment Area Using the Aesthetic Improvement Scale for Radiance
A "responder" is a participant who shows aesthetic improvement in radiance of the treatment area ("Improved," "Much Improved," or "Very Much Improved" on the scale).
Measured: Month 2
Change from Baseline in Treatment Area Skin Elasticity Measurement
The trained designee will measure skin elasticity using the assigned instrument at the designated study visits.
Measured: Month 2
Change from Baseline in Treatment Area Skin Hydration Measurement
The trained designee will measure skin hydration using the assigned instrument at the designated study visits.
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start18 Jul 2024
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Quality DeficitStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 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
- NCT06547125
- Sponsor's protocol ID
- M24-486
- Status last verified
- Feb 2026
- First submitted
- 7 Aug 2024
- Last updated
- 18 Feb 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Evaluator-Blinded, Randomized, No-Treatment Controlled Study of the Effectiveness and Safety of JUVÉDERM® VOLITE™ Injectable Gel for the Improvement in Skin Quality
- ClinicalTrials.gov ID
- NCT06547125
- Acronym / sponsor ID
- M24-486
- Conditions
- Skin Quality Deficit
- Keywords
- Skin Quality Deficit, Juvederm Volite, AGN-8015
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 9 Aug 2024 (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 the treatment of fine lines and improving skin quality.
VOLITE is an investigational device being developed for improving skin quality. 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 skin quality, especially hydration and radiance, in the treatment area will be enrolled. Around 135 participants will be enrolled in the study at approximately 6 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 regular 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 (6 listed)
- Fitzpatrick skin types II-IV
- Participants' FACE-Q Satisfaction with Skin Scale scores must meet the following criteria:
Key exclusion criteria (7 listed)
- Any skin condition in the face area that might not be suitable for injection
- Uncontrolled systemic disease
- History of anaphylactic shock, or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study
- Active autoimmune disease
- Tendency to develop hypertrophic scarring
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
Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) Live Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area Using the Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 2
A "responder" is a participant who shows improvement in the overall aesthetic assessment on the treatment area using GAIS. GAIS is a 5-point scale ranging from 'Very Much Improved' to 'Worse'.
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately Month 12
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in participants, users, or other persons, whether or not related to the investigational medical device, and whether anticipated or unanticipated.
7 secondary outcomes
Percentage of Participants Achieving "Responder" Status for Participant's Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area using GAIS
Time frame: Month 2
Percentage of Participants Achieving "Responder" Status for Treating Investigator's (TI) Assessment of Global Aesthetic Improvement of Skin Quality on the Treatment Area using GAIS
Time frame: Month 2
Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Scale
Time frame: Month 2
Percentage of Participants with Responder Status based on EI's Live Assessments of Hydration Improvement on the Treatment Area Using the Aesthetic Improvement Scale for Hydration
Time frame: Month 2
Percentage of Participants with Responder Status based on EI's Live Assessments of Radiance Improvement on the Treatment Area Using the Aesthetic Improvement Scale for Radiance
Time frame: Month 2
Change from Baseline in Treatment Area Skin Elasticity Measurement
Time frame: Month 2
Change from Baseline in Treatment Area Skin Hydration Measurement
Time frame: 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 18 Feb 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.
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing JUVÉDERM® VOLITE™ in people with Skin Quality Deficit, 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 6 inclusion and 7 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 18 Feb 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) Live Assessment of Global Aesthetic Improvement in Skin Quality on the Treatment Area Using the Global Aesthetic Improvement Scale (GAIS) (time frame: Month 2). 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 18 Feb 2026.