Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT07122193
Status:
RECRUITING
Last Update Posted:
2025-11-05
First Post:
2025-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C545476', 'term': 'incobotulinumtoxinA'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "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", 'timeFrame': 'At Week 2 of MP', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "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", 'timeFrame': 'At Week 2 of MP', 'description': '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.'}, {'measure': "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", 'timeFrame': 'At Week 2 of MP', 'description': '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.'}, {'measure': "Achievement of at Least a +1 (Somewhat Satisfied) Score Using the Participant's Satisfaction Questionnaire at Week 2 of MP", 'timeFrame': 'At Week 2 of MP', 'description': 'Participants satisfaction questionnaire responses will be rated on a scale ranging from +3 (very satisfied) to -3 (very dissatisfied). A higher score indicates satisfaction.'}, {'measure': "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", 'timeFrame': 'At Week 1 and Week 4 up to Week 17 of MP', 'description': '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.'}, {'measure': "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", 'timeFrame': 'At Week 1 and Week 4 up to Week 17 of MP', 'description': '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.'}, {'measure': "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", 'timeFrame': 'At Week 1 and Week 4 up to Week 17 of MP', 'description': '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.'}, {'measure': "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", 'timeFrame': 'At Week 2 of MP', 'description': '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.'}, {'measure': "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", 'timeFrame': 'At Week 2 of MP', 'description': '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.'}, {'measure': "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", 'timeFrame': 'At Week 2 of MP', 'description': '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.'}, {'measure': "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", 'timeFrame': 'At Week 2 of MP', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platysma prominence'], 'conditions': ['Neuromuscular Agents', 'Peripheral Nervous System Agents', 'Physiological Effects of Drugs', 'Acetylcholine Release Inhibitors', 'Membrane Transport Modulators', 'Molecular Mechanisms of Pharmacological Action', 'Cholinergic Agents', 'Neurotransmitter Agents', 'incobotulinumtoxinA', 'Botulinum Toxins, Type A']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presence of four (medial and lateral, left and right) platysmal bands assessed at screening and baseline.\n* A score of Grade 3 ('moderate') or Grade 4 ('severe') on the MAPS-D at maximum contraction by the investigator and participant.\n\nExclusion Criteria:\n\n* Hypersensitivity or a history of allergic reaction to botulinum toxin of any serotype or any of their formulation ingredients.\n* Any medical condition that may put the participant at increased risk with exposure to botulinum toxin of any serotype, or any disorders that might interfere with neuromuscular function.\n* Any serious disease or disorder that could interfere with the safe completion of treatment or with study outcome assessments, or compromise participant safety.\n* Botulinum toxin treatment in the face (below the lower orbital rim), jawline, or neck within the last seven months.\n* History of lower face surgery, neck or chest surgery, aesthetic procedures, and orthodontic procedures in the past 12 months.\n* Planned surgery or aesthetic procedures to the lower face, neck, or chest during the study period.\n* Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study products)."}, 'identificationModule': {'nctId': 'NCT07122193', 'acronym': 'PLATINUM US', 'briefTitle': 'A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Parallel-Group, Double-Blind, Multicenter Study Investigating the Safety and Efficacy of NT 201 Compared With Placebo in Adult Participants With Moderate to Severe Platysma Prominence in the United States', 'orgStudyIdInfo': {'id': 'NT-PPR-US001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Main Period: NT 201', 'description': 'Participants will receive NT 201 IM injection, once on Day 1 of the MP.', 'interventionNames': ['Drug: NT 201']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Main Period: NT 201 Matching Placebo', 'description': 'Participants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP.', 'interventionNames': ['Drug: NT 201 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'OLEX Period: NT 201', 'description': 'Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX Cycle 1 and Cycle 2.', 'interventionNames': ['Drug: NT 201']}], 'interventions': [{'name': 'NT 201', 'type': 'DRUG', 'otherNames': ['IncobotulinumtoxinA', 'Xeomin/Bocouture', 'Xeomin Cosmetic', 'Xeomeen'], 'description': 'Clostridium Botulinum neurotoxin A (150 kiloDalton \\[kD\\], free of complexing proteins), powder for solution for injection.', 'armGroupLabels': ['Main Period: NT 201', 'OLEX Period: NT 201']}, {'name': 'NT 201 Placebo', 'type': 'DRUG', 'description': 'NT 201 matching-placebo', 'armGroupLabels': ['Main Period: NT 201 Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '92803', 'city': 'Vista', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '06880', 'city': 'Westport', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 41.14149, 'lon': -73.3579}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33143', 'city': 'Coral Gables', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33404', 'city': 'West Palm Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30005', 'city': 'Alpharetta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '60563', 'city': 'Naperville', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '21030', 'city': 'Hunt Valley', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 39.49983, 'lon': -76.64108}}, {'zip': '10549', 'city': 'Mount Kisco', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27517', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28405', 'city': 'Wilmington', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '19003', 'city': 'Ardmore', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 40.00678, 'lon': -75.28546}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75225', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22209', 'city': 'Arlington', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '00917', 'city': 'San Juan', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'facility': 'Merz Investigative Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'centralContacts': [{'name': 'Public Disclosure Manager Merz Aesthetics', 'role': 'CONTACT', 'email': 'Aesthetic.Trials@merz.com', 'phone': '+1 984-301-3095'}], 'overallOfficials': [{'name': 'Merz Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz North America, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz North America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}