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The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe platysma prominence. The study will be conducted in two periods: Main Period (MP) and Open label Extension Period (OLEX).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Period: NT 201 | Experimental | Participants will receive NT 201 IM injection, once on Day 1 of the MP. |
|
| Main Period: NT 201 Matching Placebo | Placebo Comparator | Participants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP. |
|
| OLEX Period: NT 201 | Experimental | Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX Cycle 1 and Cycle 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT 201 | Drug | Clostridium Botulinum neurotoxin A (150 kiloDalton [kD], free of complexing proteins), powder for solution for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Achievement of Grade 1 or Grade 2 And at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) At Week 2 of MP | MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement. | At Week 2 of MP |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) And at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPS-D at Week 2 of MP | MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement. | At Week 2 of MP |
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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 Investigative Site | Scottsdale | Arizona | 85260 | United States | ||
| Merz Investigative Site |
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|
| NT 201 Placebo | Drug | NT 201 matching-placebo |
|
| Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) And at Least a 2-Grade Improvement From Baseline Based on the Participant's Self-Assessment Using MAPS-D at Week 2 of MP | MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement. | At Week 2 of MP |
| Achievement of at Least a +1 (Somewhat Satisfied) Score Using the Participant's Satisfaction Questionnaire at Week 2 of MP | Participants satisfaction questionnaire responses will be rated on a scale ranging from +3 (very satisfied) to -3 (very dissatisfied). A higher score indicates satisfaction. | At Week 2 of MP |
| Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) And at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP | MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement. | At Week 1 and Week 4 up to Week 17 of MP |
| Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) And at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP | MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement. | At Week 1 and Week 4 up to Week 17 of MP |
| Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) And at Least a 2-Grade Improvement From Baseline Based on Participant's Self-Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP | MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement. | At Week 1 and Week 4 up to Week 17 of MP |
| Achievement of at Least a +1 (Improved) Score on the Global Aesthetic Improvement Scale (GAIS)-Platysmal Bands Based on the Investigator's Assessment at Week 2 of MP | GAIS is a balanced seven-point Likert scale (range -3 [very much worse] to +3 [very much improved]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement. | At Week 2 of MP |
| Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands Based on the Participant's Self-Assessment at Week 2 of MP | GAIS is a balanced seven-point Likert scale (range -3 [very much worse] to +3 [very much improved]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement. | At Week 2 of MP |
| Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Investigator's Assessment at Week 2 of MP | GAIS is a balanced seven-point Likert scale (range -3 [very much worse] to +3 [very much improved]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement. | At Week 2 of MP |
| Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Participant's Self-Assessment at Week 2 of MP | GAIS is a balanced seven-point Likert scale (range -3 [very much worse] to +3 [very much improved]) commonly used in aesthetic medicine to rate post-treatment improvement in appearance. A higher score indicates improvement. | At Week 2 of MP |
| Encino |
| California |
| 91436 |
| United States |
| Merz Investigative Site | Los Angeles | California | 90069 | United States |
| Merz Investigative Site | Redondo Beach | California | 90277 | United States |
| Merz Investigative Site | Santa Monica | California | 90404 | United States |
| Merz Investigative Site | Vista | California | 92803 | United States |
| Merz Investigative Site | Greenwood Village | Colorado | 80111 | United States |
| Merz Investigative Site | Westport | Connecticut | 06880 | United States |
| Merz Investigative Site | Washington D.C. | District of Columbia | 20037 | United States |
| Merz Investigative Site | Aventura | Florida | 33180 | United States |
| Merz Investigative Site | Boca Raton | Florida | 33431 | United States |
| Merz Investigative Site | Bradenton | Florida | 34209 | United States |
| Merz Investigative Site | Coral Gables | Florida | 33143 | United States |
| Merz Investigative Site | Coral Gables | Florida | 33146 | United States |
| Merz Investigative Site | West Palm Beach | Florida | 33404 | United States |
| Merz Investigative Site | Alpharetta | Georgia | 30005 | United States |
| Merz Investigative Site | Naperville | Illinois | 60563 | United States |
| Merz Investigative Site | Hunt Valley | Maryland | 21030 | United States |
| Merz Investigative Site | Mount Kisco | New York | 10549 | United States |
| Merz Investigative Site | New York | New York | 10021 | United States |
| Merz Investigative Site | New York | New York | 10028 | United States |
| Merz Investigative Site | Chapel Hill | North Carolina | 27517 | United States |
| Merz Investigative Site | Wilmington | North Carolina | 28405 | United States |
| Merz Investigative Site | Ardmore | Pennsylvania | 19003 | United States |
| Merz Investigative Site | Nashville | Tennessee | 37215 | United States |
| Merz Investigative Site | Dallas | Texas | 75225 | United States |
| Merz Investigative Site | Arlington | Virginia | 22209 | United States |
| Merz Investigative Site | San Juan | 00917 | Puerto Rico |
| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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