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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 an investigational botulinum toxin type A product being studied for dermatologic uses, including glabellar frown lines, forehead rhytides, and skin aging with fine wrinkles. It is in clinical development by Evolus, Inc. (EOLS) and is not yet approved for these indications.
PrabotulinumtoxinA-Xvfs is a botulinum toxin type A that works by blocking nerve signals to muscles, temporarily reducing muscle activity that causes wrinkles. This mechanism underlies its use in treating glabellar lines and forehead rhytides by relaxing the muscles responsible for these expression lines.
PrabotulinumtoxinA-Xvfs is being developed by Evolus, Inc., a company traded on the stock market under the ticker EOLS. Evolus is focused on aesthetic medicine and is conducting clinical trials to evaluate this product for facial wrinkle treatments.
PrabotulinumtoxinA-Xvfs is in Phase 2 clinical development for glabellar frown lines, based on a completed Phase 2 trial. It has also been studied in earlier-phase trials for forehead rhytides and skin aging. It remains investigational and has not received FDA approval.
PrabotulinumtoxinA-Xvfs has been studied in three completed trials: NCT05320393, a Phase 2 study of 40 units for glabellar lines with 154 participants; NCT05807412, an early Phase 1 study comparing spread versus onabotulinumtoxinA for forehead rhytides with 10 participants; and NCT06604832, a Phase 1 study of microtox for facial skin quality with 20 female participants.
PrabotulinumtoxinA-Xvfs is not the same as Botox, though both are botulinum toxin type A products. In a clinical trial, PrabotulinumtoxinA-Xvfs was compared directly with onabotulinumtoxinA, the active ingredient in Botox, to assess differences in spread when treating forehead rhytides. They are distinct products.