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

NCT06547125 | Completed Phase 2

• 1 other identifier: M24-486
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Skin Quality Deficit

Keywords

Skin Quality Deficit; Juvederm Volite; AGN-8015

Outcome Measures

Primary Outcomes (2)

• 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 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

  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

  Month 2

• Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Scale

  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

  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

  Month 2

Study Arms (2)

JUVÉDERM® VOLITE™

EXPERIMENTAL

Participants in the treatment group will receive a single dose at the study initiation. Participants are eligible for touch up treatment.

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.

Device: JUVÉDERM® VOLITE™; Other: Control

Interventions

JUVÉDERM® VOLITE™ DEVICE

Injection, intradermal

Also known as: AGN-8015

Control - No Treatment; JUVÉDERM® VOLITE™

Control OTHER

No-treatment control

Control - No Treatment

Eligibility Criteria

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

You may qualify if:

• 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?

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (6)

China-Japan Friendship Hospital /ID# 260959

Beijing, Beijing Municipality, 100029, China

Location

Peking University First Hospital /ID# 260957

Xicheng District, Beijing Municipality, 100034, China

Location

Nanjing Drum Tower Hospital /ID# 260950

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University /ID# 260951

Nanjing, Jiangsu, 210009, China

Location

Huashan Hospital, Fudan University /ID# 261582

Shanghai, Shanghai Municipality, 200040, China

Location

Hangzhou First People's Hospital /ID# 260952

Hangzhou, Zhejiang, 310003, China

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: July 18, 2024
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

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)