A Study to Assess Adverse Events and Effectiveness of Injected JUVÉDERM® VOLITE™ Gel Filler for Change in Neck Lines in Adult Chinese Participants
NCT ID: NCT05741034
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
159 participants
INTERVENTIONAL
2023-04-07
2024-12-09
Brief Summary
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VOLITE is an investigational product being developed for correction of transverse neck lines. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 159 adult participants with transverse neck lines will be enrolled in the study at approximately 8 sites in China.
Participants in the treatment group will receive the initial injection of VOLITE at Visit 1 and followed for up to 13 months. Participants may have the opportunity to receive optional touch-up treatment of VOLITE during the follow-up duration period. Participants in the control group will receive no treatment but will have the opportunity to receive VOLITE treatment after 2 months. Participants in the control group will be followed for up to 10 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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JUVÉDERM® VOLITE™
Participants will receive VOLITE for initial treatment and exit the study at month 12 after last treatment.
Participants may have the opportunity to receive optional touch-up treatment of VOLITE during the follow-up duration period.
JUVÉDERM® VOLITE™
Injection, subdermal and/or intradermal
Control - No Treatment
Participants in the control group will receive no treatment. At Month 2, these participants will have the option to receive VOLITE treatment and exit the study at month 9 after last treatment.
JUVÉDERM® VOLITE™
Injection, subdermal and/or intradermal
Control
No-treatment control
Interventions
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JUVÉDERM® VOLITE™
Injection, subdermal and/or intradermal
Control
No-treatment control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants seeking improvement of transverse neck lines and hydration in neck area.
* Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment.
* The participant is able to achieve at least a 1-point improvement in Allergan Transverse Neck Lines Scale (ATNLS) score with the allowed injection volume in the judgment of TI.
Exclusion Criteria
* History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA (hyaluronic acid) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
* Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease).
* Current cutaneous inflammatory or infectious processes (e.g., acne, herpes, dermatitis), abscess, an unhealed wound, or a cancerous or precancerous lesion on skin of the neck.
* History of thyroid cancer, thyroid-related diseases, skin cancer of the neck, radiation of the treatment area, or de novo cancer in the treatment area.
* Tendency to develop hypertrophic scarring.
* Has ever received permanent soft tissue fillers (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene), calcium hydroxyapatite filler, or autologous fat in the neck area.
* Has undergone neck surgery.
* Semi-permanent soft tissue fillers (e.g., poly-L-lactic acid, polycaprolactone) in the neck area within 2 years before enrollment.
* Botulinum toxin in the neck area within 6 months before enrollment.
* Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with the visualization of the neck area for the effectiveness assessments.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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China-Japan Friendship Hospital /ID# 243984
Beijing, Beijing Municipality, China
Beijing Hospital /ID# 243982
Beijing, Beijing Municipality, China
Peking University First Hospital /ID# 243980
Xicheng District, Beijing Municipality, China
The Third Affiliated Hospital, Sun Yat-Sen University /ID# 243987
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 243981
Wuhan, Hubei, China
Zhongda Hospital Southeast University /ID# 243986
Nanjing, Jiangsu, China
Wuxi People's Hospital /ID# 245875
Wuxi, Jiangsu, China
Huashan Hospital, Fudan University /ID# 244044
Shanghai, Shanghai Municipality, China
Tianjin Medical University General Hospital /ID# 244107
Tianjin, Tianjin Municipality, China
Countries
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Related Links
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Other Identifiers
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M21-870
Identifier Type: -
Identifier Source: org_study_id