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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
prabotulinumtoxinA · 1 trial · 1 indication
Time to return to baseline Glabellar Line Scale (GLS) score at maximum frown, as assessed by the blinded evaluating investigator. The Glabellar Line Scale (GLS) scale ranges from a score of 0 to 3, and a higher score indicates greater (more severe) glabellar wrinkles.
| Arm | Type | Description |
|---|---|---|
| OLD (4 U per 0.1 mL) | ACTIVE_COMPARATOR | The total Jeuveau dose will be 20U divided into 5 injections. Each subject will receive a total of 0.5 mL of Jeuveau during the treatment. |
| COLD (4 U per 0.02 mL group) | ACTIVE_COMPARATOR | The total Jeuveau dose will be 20U divided into 5 injections. Each injection will receive a total of 0.1 mL of Jeuveau during the treatment. |
| Name | Type | Description |
|---|---|---|
| prabotulinumtoxinA | DRUG | Injection of glabellar rhytids |
Inclusion Criteria: * At least 18 years of age at the time of signing the informed consent. * Overtly healthy as determined by medical evaluation (includes: medical history, physical examination, and vital signs). * Subjects have moderate or severe dynamic glabellar lines on maximum frown as assess...
PrabotulinumtoxinA is being studied for the treatment of glabellar frown lines, the vertical lines that form between the eyebrows. It is a dermatology-focused injectable therapeutic. The clinical program has evaluated its use in adult female participants with glabellar lines.
PrabotulinumtoxinA targets SNAP25, a proteolytic enzyme involved in neurotransmitter release. By acting on SNAP25, the drug is designed to modulate the signaling that contributes to muscle contraction underlying glabellar frown lines. This mechanism is central to its development as a dermatologic treatment.
PrabotulinumtoxinA is being developed by Evolus, Inc., which trades under the ticker EOLS. Evolus is the sponsor of the clinical program evaluating the drug for glabellar frown lines.
PrabotulinumtoxinA is in Phase 1 clinical development. The program includes one completed early Phase 1 trial. It is an investigational therapy and has not been approved by the FDA for the studied indication.
PrabotulinumtoxinA has been evaluated in a single completed trial, NCT05129319, titled Jeuveau Treatment of Glabellar Lines Using OLD Versus COLD. The trial enrolled 30 participants in the United States, was randomized, double-blind, and active-controlled, and included adult female healthy volunteers.