Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication JEUVEAU is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. JEUVEAU is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle… FDA label
Also known as Jeuveau, Jeaveau
PrabotulinumtoxinA-Xvfs · 3 trials · 4 indications
Effectiveness of prabotulinumtoxinA 40 Units compared to prabotulinumtoxinA 20 Units will be assessed for each subject based on the number of days from baseline to the day that the Glabellar Line Scale (GLS) severity, by Investigator Assessment, returns to the baseline value. The treatment will be considered to remain effective for the amount of time during which the GLS severity at maximum frown has not returned to baseline severity.
The treating physician and the blinded, secondary evaluator will rate the subject after the final treatment. The scale identifies 6 parameters of skin quality: (1) loss of elasticity, (2) wrinkles, (3) roughness, (4) pigmentation/lentigines, (5) erythema, and (6) pore size. The scale has 5 points to describe the intensity of parameters 1-5: 0 implies none, 1 implies mild, 2 implies moderate, 3 implies severe, and 4 implies very severe. For parameter 6, 0 implies fine, 1 implies small, 2 implies moderate, 3 implies large, and 4 implies very large.
The treating physician and the blinded, secondary evaluator will rate the subject after the final treatment. Based on aesthetic appearance, qualitative success of treatment will be evaluated using the GAIS. Aesthetic appearance will be rated one of the five following options: - Worse: The appearance is worse than the original condition - No Change: The appearance is essentially the same as the original condition - Improved: Obvious improvement in appearance from the initial condition, but a touchup or re-treatment is indicated - Much Improved: Marked improvement in appearance but not completely optimal for this patient. A touchup would slightly improve the result - Very Much Improved: Optimal cosmetic result for the treatment in this patient.
Primary endpoint is surface area of rhytid diminution. Surface area of rhytid reduction will be measured in centimeters squared (incorporating length and width measurements) two-weeks post-injection to assess differences, if any, in rhytid reduction on each side of the forehead by the blinded investigator.
| Arm | Type | Description |
|---|---|---|
| Study Drug | EXPERIMENTAL | 40U of PrabotulinumtoxinA-xvfs |
| OnabotulinumtoxinA | ACTIVE_COMPARATOR | 20U of OnabotulinumtoxinA |
| PrabotulinumtoxinA-xvfs | ACTIVE_COMPARATOR | 20U of PrabotulinumtoxinA-xvfs |
| Treated with prabotulinumtoxinA-xvfs and placebo | PLACEBO_COMPARATOR | Subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12. Approximately 20 units of prabotulinumtoxinA-xvfs will be injected into the left side of the subject's glabellar lines and forehead region, and a placebo saline treatment will be injected into the right side of the subject's glabellar lines and forehead region. |
| Treated with prabotulinumtoxinA-xvfs and incobotulinumtoxinA | ACTIVE_COMPARATOR | Subjects will have one treatment session at week 0 and two live assessment visits at weeks 2 and 12. Approximately 20 units of prabotulinumtoxinA-xvfs will be injected into the left side of the subject's glabellar lines and forehead region, and approximately 20 units of incobotulinumtoxinA will be injected into the right side of the subject's glabellar lines and forehead region. |
| Experimental half | EXPERIMENTAL | Each subject will be randomized to have either their right forehead or left forehead treated with 4 units or 0.1 cc of prabotulinumtoxinA 2.5 cm above the orbital rim. |
| Comparator half | ACTIVE_COMPARATOR | Each subject will be randomized to have either their right forehead or left forehead treated with 4 units or 0.1 cc of onabotulinumtoxinA 2.5 cm above the orbital rim. |
| Name | Type | Description |
|---|---|---|
| PrabotulinumtoxinA-Xvfs | DRUG | One treatment of 40 units |
| OnabotulinumtoxinA | DRUG | One treatment of 20 units |
| IncobotulinumtoxinA | DRUG | Each vial of incobotulinumtoxinA contains 100 units of product, and it will be reconstituted with 5 mL of bacteriostatic saline solution. 20 units of this intervention will only be injected to the right side of subject faces - intramuscularly to the corrugator supercilii and intradermally to the forehead region. |
| saline solution (placebo) | DRUG | As a placebo treatment, saline solution will be injected on the right side of the glabellar lines and forehead region instead of an active neuromodulator. The saline solution has no therapeutic effect and is used as a control to compare the results against the active treatment. |
Inclusion Criteria: * Outpatient, male or female of any race, 18 years of age or older. * Female subjects of childbearing potential must have a negative urine pregnancy test during Visits 1 (Screening) and Visit 2 (if applicable) and practice a reliable method of contraception for the duration of t...
PrabotulinumtoxinA-xvfs is studied for glabellar frown lines, rhytides, and skin aging in dermatology. Clinical trials have evaluated it for forehead rhytides and for facial skin quality, fine wrinkles, and texture, including a Phase 2 study of 40 units for glabellar lines.
PrabotulinumtoxinA-xvfs targets SNAP25, a proteolytic enzyme component of the SNARE complex involved in neurotransmitter release. Its target class is a proteolytic enzyme. This mechanism underlies its use in dermatology for facial lines and wrinkles.
PrabotulinumtoxinA-xvfs is developed by Evolus, Inc., which trades under the ticker EOLS. Evolus is the sponsor of the clinical trials evaluating the agent in dermatology indications including glabellar frown lines and rhytides.
PrabotulinumtoxinA-xvfs is in Phase 2 clinical development. A completed Phase 2 study enrolled 154 participants to assess safety and duration of effect of 40 units for glabellar lines. Earlier Phase 1 and Early Phase 1 studies have also been completed.
PrabotulinumtoxinA-xvfs has been studied in NCT05320393, a completed Phase 2 trial of 40 units for glabellar lines with 154 participants, NCT05807412, a completed Early Phase 1 study of spread versus onabotulinumtoxinA in forehead rhytides, and NCT06604832, a completed Phase 1 study of facial skin quality.