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JUVÉDERM VOLITE, Control · 3 trials · 3 indications
A "responder" is a participant with at least 1-grade improvement on the ATNLS. ATNLS is a 5-point photonumeric scale to grade the severity of transverse neck lines (0=None, 4=Extreme).
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
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.
A "responder" is a participant who shows improvement in the overall aesthetic assessment on the treatment area using GAIS. GAIS is a 5-point scale ranging from 'Very Much Improved' to 'Worse'.
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in participants, users, or other persons, whether or not related to the investigational medical device, and whether anticipated or unanticipated.
| Arm | Type | Description |
|---|---|---|
| JUVÉDERM® VOLITE™ | EXPERIMENTAL | 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. |
| Control - No Treatment | OTHER | 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. |
| Name | Type | Description |
|---|---|---|
| JUVÉDERM® VOLITE™ | DEVICE | Injection, subdermal and/or intradermal |
| Control | OTHER | No-treatment control |
Inclusion Criteria: * Participants in general good health as determined by Treating Investigator's (TI) judgment, including no known active pandemic infection. * Participants seeking improvement of transverse neck lines and hydration in neck area. * Has moderate or severe transverse neck lines (ATN...
JUVÉDERM VOLITE is an investigational gel filler being studied for the improvement of skin quality deficit, neck lines, and perioral lines (fine lines around the mouth). It is developed by AbbVie Inc. (ABBV) and is currently in Phase 3 clinical development for these dermatology indications.
JUVÉDERM VOLITE is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The product is being studied in clinical trials for dermatology indications including skin quality deficit, neck lines, and perioral lines.
JUVÉDERM VOLITE is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. Clinical trials are being conducted to assess its effectiveness and safety for treating skin quality deficit, neck lines, and perioral lines.
JUVÉDERM VOLITE has been studied in three completed clinical trials in China. NCT05454033 assessed its effect on perioral lines in 198 participants, NCT05741034 assessed neck lines in 159 participants, and NCT06547125 assessed skin quality improvement in 135 participants. All trials enrolled adults aged 18 years and older.
JUVÉDERM VOLITE is the product name used in clinical trials. No alternative names have been reported. The trials refer to it as JUVÉDERM® VOLITE™ gel filler, and it is being studied for aesthetic dermatology indications such as fine lines around the mouth and neck lines.