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NCT05316233 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 159
- Enrollment target
NCT05316233 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 159 participants.
The verdict
NCT05316233, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 159 participants
- Enrollment target
Study Summary
The cumulative effect of aging and environmental exposures (ie, 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 HA gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of treating fine lines and improving skin quality. The purpose of this study is to assess adverse events and effectiveness of VOLITE XC in adults seeking improvement in neck appearance. 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.
Interventions
- DEVICE VOLITE XC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2022-05-02 |
| Est. Completion | 2024-09-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05316233
The ClinicalTrials.gov registry entry for NCT05316233 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VOLITE XC is the first listed.
NCT05316233 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05316233 about?
NCT05316233 is a clinical study titled "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". The cumulative effect of aging and environmental exposures (ie, 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 ...
What is the current status of trial NCT05316233?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 159 participants. The study started on 2022-05-02. Estimated completion is 2024-09-12.
What interventions are being tested in trial NCT05316233?
The interventions under investigation include: VOLITE XC (DEVICE).
Who is sponsoring clinical trial NCT05316233?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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