JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance
Public ClinicalTrials.gov record NCT05316233. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter, Evaluator-blinded, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The cumulative effects of aging, weight change, ergonomics (i.e., "tech neck"), and environmental exposures (i.e., ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The neck is a frequently mentioned area by patients complaining about its crepey texture and deep lines. VOLITE XC is a crosslinked hyaluronic acid (HA) gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of treating fine lines and improving skin smoothness. The purpose of this study is to assess safety and effectiveness of VOLITE XC in adults seeking improvement in neck appearance. VOLITE XC is an investigational product intended to reduce horizontal neck lines for improvement of neck appearance. Participants are placed in 1 of 2 groups, called treatment arms. Participation will be randomized in a 2:1 ratio in treatment and control arms. Up to 212 adult participants with moderate or severe transverse neck lines will be enrolled in the study at up to 20 sites. Participants in the treatment group will receive VOLITE XC at Day 1 and be 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 be 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.
Study identification
- NCT ID
- NCT05316233
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 159 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2, 2022 (Actual)
- Primary completion
- Sep 12, 2024 (Actual)
- Completion
- Sep 12, 2024 (Actual)
- Last update posted
- Sep 3, 2026
2022 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Steve Yoelin MD Medical Associate Inc /ID# 239072 | Newport Beach | California | 92663 | — |
| Laser & Skin surgery Medical group, Inc /ID# 241999 | Sacramento | California | 95816-5520 | — |
| Cosmetic Laser Dermatology /ID# 239121 | San Diego | California | 92121-2119 | — |
| Art of Skin MD /ID# 239071 | Solana Beach | California | 92075-2228 | — |
| Center for Dermatology and Dermatologic Surgery /ID# 239137 | Washington D.C. | District of Columbia | 20037-1445 | — |
| Hevia Cosmetic Dermatology /ID# 239118 | Coral Gables | Florida | 33134 | — |
| Skin Research Institute LLC /ID# 239109 | Coral Gables | Florida | 33146-1837 | — |
| Research Institute of the Southeast, LLC /ID# 239070 | West Palm Beach | Florida | 33401-2712 | — |
| Delricht Research /ID# 242001 | New Orleans | Louisiana | 70115 | — |
| Rkmd, Llc /Id# 239075 | North Bethesda | Maryland | 20852-3093 | — |
| image Dermatology, P.C. /ID# 239136 | Montclair | New Jersey | 07042 | — |
| Skin And Aesthetics Surgery Of Manhattan /ID# 243607 | New York | New York | 10022-3607 | — |
| Mariwalla Dermatology /ID# 239102 | West Islip | New York | 11795-4916 | — |
| Aesthetic Solutions /ID# 239074 | Chapel Hill | North Carolina | 27517-9901 | — |
| Bellaire Dermatology Associates /ID# 239133 | Bellaire | Texas | 77401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05316233, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05316233 live on ClinicalTrials.gov.