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The purpose of this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT 201 Dose 1 | Experimental | Subjects will receive Dose 1. |
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| NT 201 Dose 2 | Experimental | Subjects will receive Dose 2. |
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| NT 201 Dose 3 | Experimental | Subjects will receive Dose 3. |
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| Placebo | Placebo Comparator | Subjects will receive matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT 201 | Drug | Clostridium botulinum neurotoxin type A (150 kiloDalton [kD], free of complexing proteins) powder for solution for injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (V4) | The platysma area will be assessed live by the investigator at maximum contraction and graded according to the validated five-point Merz Aesthetic Platysma Scale-Dynamic (MAPS-D). Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). | Baseline (Screening Visit), Week 2 (V4) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at V4 | The platysma area will be assessed by the subjects at maximum contraction and graded according to the validated five-point MAPS-D. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). | Baseline (Screening Visit), Week 2 (V4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigation Site #0010170 | Washington D.C. | District of Columbia | 20037 | United States | ||
| Merz Investigational Site #0010453 |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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| NT 201 Placebo | Drug | NT 201 Matching-placebo. |
|
| Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs) |
TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. An AE is considered to be related if a causal relationship between NT 201 and the AE is at least reasonably possible. |
| Baseline up to Week 17/End of Study |
| Aventura |
| Florida |
| 33180 |
| United States |
| Merz Investigation Site #0010470 | Coral Gables | Florida | 33143 | United States |
| Merz Investigation Site #0010105 | Metairie | Louisiana | 70006 | United States |
| Merz Investigation Site #0010471 | Verona | New Jersey | 07044 | United States |
| Merz Investigation Site #0010469 | New York | New York | 10022 | United States |
| Merz Investigation Site #0010405 | New York | New York | 10028 | United States |