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

NCT05454033 | Completed Phase 3

• 1 other identifier: M21-528
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 11

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 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.

Conditions

Perioral Lines

Keywords

Dermal; Dermatology; Aesthetics; Skin Care; Juvederm; Volite; Perioral; Fine Lines; Wrinkles; Frown Lines; Laugh Lines

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Up to Month 2

• The percentage of participants assessed as "improved" or "much improved" on the Global Aesthetic Improvement Scale (GAIS) by the participant

  Up to Month 2

• The change from baseline on the FACE-Q Appraisal of Lines: Lips questionnaire

  Up to 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:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (11)

China-Japan Friendship Hospital /ID# 252139

Beijing, Beijing Municipality, 100029, China

Location

Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 231394

Beijing, Beijing Municipality, 100144, China

Location

Beijing Hospital /ID# 231393

Beijing, Beijing Municipality, 100730, China

Location

Peking University First Hospital /ID# 231392

Xicheng District, Beijing Municipality, 100034, China

Location

The Third Affiliated Hospital, Sun Yat-Sen University /ID# 231398

Guangzhou, Guangdong, 510630, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231396

Wuhan, Hubei, 430022, China

Location

Nanjing Drum Tower Hospital /ID# 231937

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University /ID# 244045

Nanjing, Jiangsu, 210009, China

Location

Huashan Hospital, Fudan University /ID# 231395

Shanghai, Shanghai Municipality, 200040, China

Location

West China Hospital, Sichuan University /ID# 231740

Chengdu, Sichuan, 610041, China

Location

Hangzhou First People's Hospital /ID# 244111

Hangzhou, Zhejiang, 310003, China

Location

Related Links

• clinical study report synopsis

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 12, 2022
• Study Start: September 7, 2022
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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 (11)