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Botulinum toxin, Type A · 2 trials · 1 indication
The primary efficacy end point assesses the effectiveness of DWP-450 against placebo on Day 30. The primary efficacy measure is a composite end point. Using the GLS scale, investigators and subjects will assess the glabellar lines at Day 0 and Day 30. A subject is a responder only if both the investigator and subject independently agree that a ≥2 improvement has occurred from Day 0 to Day 30. GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe.
| Arm | Type | Description |
|---|---|---|
| Botulinum toxin, Type A | EXPERIMENTAL | Botulinum toxin, Type A |
| Placebo | PLACEBO_COMPARATOR | 0.9 % sterile, unpreserved saline |
| Name | Type | Description |
|---|---|---|
| Botulinum toxin, Type A | BIOLOGICAL | Botulinum toxin, Type A |
| 0.9% sterile, unpreserved saline | OTHER | Placebo |
Inclusion Criteria: * Subjects is an adult, of at least 18 years of age * Subject is able to provide informed consent and comply with study instructions * Subject has moderate to severe glabellar lines at maximum frown as assessed by the investigator using the GLS * Subject has moderate to severe g...
Botulinum toxin, Type A is being developed by Evolus for the treatment of glabellar frown lines, the vertical lines that form between the eyebrows. The clinical program focuses on this aesthetic dermatology indication, with two completed Phase 3 trials enrolling a total of 654 participants.
Botulinum toxin, Type A targets SNAP25, a hydrolytic enzyme involved in neurotransmitter release. By acting on SNAP25, the drug is designed to reduce the muscle contractions that produce glabellar frown lines. This targeted mechanism underlies its development for aesthetic use in the glabellar region.
Botulinum toxin, Type A 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.
Botulinum toxin, Type A is in Phase 3 development for glabellar frown lines. Two Phase 3 trials have been completed, and no active trials are currently listed. The drug remains investigational and is not approved for this indication.
Botulinum toxin, Type A has been studied in two completed Phase 3 trials: NCT02334436 (EV-002), which enrolled 324 participants, and NCT02334423 (EV001), which enrolled 330 participants. Both were randomized, double-blind, placebo-controlled studies conducted in the United States in adults with glabellar frown lines.