A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants For the Improvement of Skin Quality

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.

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 Overview

• Status: Completed
• Conditions: Skin Quality Deficit
• Intervention / Treatment: Device: JUVÉDERM® VOLITE™; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • China-Japan Friendship Hospital /ID# 260959
    • Xicheng District, Beijing Municipality, China, 100034
      • Peking University First Hospital /ID# 260957
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital /ID# 260950
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University /ID# 260951
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital, Fudan University /ID# 261582
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Hangzhou First People's Hospital /ID# 260952

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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?

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JUVÉDERM® VOLITE™; Participants in the treatment group will receive a single dose at the study initiation. Participants are eligible for touch up treatment.	Device: JUVÉDERM® VOLITE™; Injection, intradermal; Other Names: AGN-8015
Other: Control - No Treatment; Participants in the control group will receive no treatment. At Month 2, these participants will have the option to receive the treatment.	Device: JUVÉDERM® VOLITE™; Injection, intradermal; Other Names: AGN-8015; Other: Control; No-treatment control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	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.	Up to approximately Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	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'.	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.	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).	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).	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.	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).	Month 2

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Actual): February 5, 2026
• Study Completion (Actual): February 5, 2026

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Skin Quality Deficit; Juvederm Volite; AGN-8015
• Other Study ID Numbers: M24-486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No