A Study to Assess Adverse Events and Change in Disease Activity of JUVÉDERM® VOLITE™ XC Injectable Gel for Change in Neck Appearance in Adult Participants
NCT ID: NCT05316233
Last Updated: 2025-04-29
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
2022-05-02
2024-09-12
Brief Summary
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VOLITE XC is an investigational product being developed for the improvement of horizontal 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 212 adult participants with transverse neck lines will be enrolled in the study at approximately 20 sites.
Participants in the treatment group will receive VOLITE XC at Day 1 and followed for up to 14 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of VOLITE XC during the follow-up duration period. The control group received no treatment and will be followed for up to 6 months after randomization. Participants can then opt to receive VOLITE XC and followed for 6 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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VOLITE XC
Participants will receive VOLITE XC for initial treatment and followed for up to 14 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of VOLITE XC during the follow-up duration period.
VOLITE XC
Intradermal Injection
VOLITE XC
Subdermal Injection
Control Group
The control group received no treatment and will be followed for up to 6 months after randomization. Participants can then opt to receive VOLITE XC and followed for 6 Months.
VOLITE XC
Intradermal Injection
VOLITE XC
Subdermal Injection
Interventions
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VOLITE XC
Intradermal Injection
VOLITE XC
Subdermal Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants seeking improvement of transverse neck lines.
* Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment.
Exclusion Criteria
* Significant skin pigmentation disorders or discoloration in the neck area that would interfere with the visual assessment of the neck area.
* Current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the neck.
* Tendency to develop hypertrophic scarring.
* History of thyroid cancer, skin cancer of the neck, radiation of the treatment area, or de novo cancer in the treatment area.
* Permanent soft tissue fillers in the neck area.
* Semi-permanent soft tissue fillers in the neck area within 2 years before enrollment.
* HA fillers or autologous fat in the neck area within 12 months before enrollment.
* Mesotherapy, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, microneedling, laser, or other cosmetic procedures in the neck area within 12 months before enrollment.
* Botulinum toxin in the neck area within 6 months before enrollment.
* Deoxycholic acid injections or cryolipolysis in the submentum area within 6 months before enrollment.
* Neck surgeries and procedures.
* Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with the visualization of the neck area for the effectiveness assessments.
* Pregnant, nursing or planning a pregnancy.
22 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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Steve Yoelin MD Medical Associate Inc /ID# 239072
Newport Beach, California, United States
Laser & Skin surgery Medical group, Inc /ID# 241999
Sacramento, California, United States
Cosmetic Laser Dermatology /ID# 239121
San Diego, California, United States
Art of Skin MD /ID# 239071
Solana Beach, California, United States
Center for Dermatology and Dermatologic Surgery /ID# 239137
Washington D.C., District of Columbia, United States
Hevia Cosmetic Dermatology /ID# 239118
Coral Gables, Florida, United States
Skin Research Institute LLC /ID# 239109
Coral Gables, Florida, United States
Research Institute of the Southeast, LLC /ID# 239070
West Palm Beach, Florida, United States
Delricht Research /ID# 242001
New Orleans, Louisiana, United States
Rkmd, Llc /Id# 239075
North Bethesda, Maryland, United States
image Dermatology, P.C. /ID# 239136
Montclair, New Jersey, United States
Skin And Aesthetics Surgery Of Manhattan /ID# 243607
New York, New York, United States
Mariwalla Dermatology /ID# 239102
West Islip, New York, United States
Aesthetic Solutions /ID# 239074
Chapel Hill, North Carolina, United States
Bellaire Dermatology Associates /ID# 239133
Bellaire, Texas, United States
Countries
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Related Links
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Other Identifiers
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2029-701-008
Identifier Type: -
Identifier Source: org_study_id
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