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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, Control is an investigational gel filler being studied for perioral lines, neck lines, and skin quality deficit. It is in Phase 3 clinical development for these dermatology indications. The product is not approved and remains under clinical investigation.
JUVÉDERM VOLITE, Control is developed by AbbVie Inc., traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials for this product in China.
JUVÉDERM VOLITE, Control is in Phase 3 clinical development for perioral lines and neck lines, and has completed a Phase 2 trial for skin quality deficit. It is an investigational product and has not been approved by regulatory authorities.
JUVÉDERM VOLITE, Control has completed three clinical trials in China. NCT05454033 assessed its effectiveness for perioral lines in 198 participants. NCT05741034 studied neck lines in 159 participants. NCT06547125 evaluated skin quality improvement in 135 participants.
JUVÉDERM VOLITE, Control is a version of the JUVÉDERM VOLITE gel filler. Clinical trials reference JUVÉDERM® VOLITE™ as the product being studied, with 'Control' indicating a controlled study design. The product is being evaluated for cosmetic improvements in facial lines.