Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines
NCT ID: NCT04594213
Last Updated: 2024-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
362 participants
INTERVENTIONAL
2020-09-23
2022-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Main Period: Placebo (Group P)
Subjects will receive placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period.
Placebo
Solution for injection prepared by reconstitution of powder with percent (%) Sodium Chloride (NaCl).
Main Period: NT 201 (Group U)
Subjects will receive a total of 64 Units (U) of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period.
NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% NaCl.
Main Period: NT 201 and Placebo (Group G and H)
Subjects will receive a total of 40 U of NT 201: 20 U of NT 201 injection both in the GFL and HFL area, and placebo injection in the LCL area on Day 1 of main period.
NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% NaCl.
Placebo
Solution for injection prepared by reconstitution of powder with percent (%) Sodium Chloride (NaCl).
OLEX: NT 201 (Main Period: Group P)
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% NaCl.
OLEX: NT 201 (Main Period: Group U)
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% NaCl.
OLEX: NT 201 (Main Period: Group G and H)
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% NaCl.
Interventions
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NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% NaCl.
Placebo
Solution for injection prepared by reconstitution of powder with percent (%) Sodium Chloride (NaCl).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Horizontal forehead lines (HFL), glabellar frown lines (GFL), and symmetrical lateral canthal lines (LCL) of moderate to severe intensity at maximum contraction as assessed by the investigator and subject according to Merz Aesthetics Scales (MAS).
Exclusion Criteria
* Any facial cosmetic procedure within the last 12 months before baseline injection.
* Previous treatment with any biodegradable filler in the face within the last 12 months before injection.
* Any previous insertion of permanent material in the face (regardless of the time between previous treatment and this study).
* Any medical condition that may put the subject at increased risk with exposure to NT201.
18 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Merz North America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz North America, Inc.
Locations
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Merz Investigational Site
Encino, California, United States
Merz Investigational Site
Newport Beach, California, United States
Merz Investigational Site
San Diego, California, United States
Merz Investigational Site
Greenwood Village, Colorado, United States
Merz Investigational Site
Washington D.C., District of Columbia, United States
Merz Investigational Site
Aventura, Florida, United States
Merz Investigational Site
Boca Raton, Florida, United States
Merz Investigational Site
Metairie, Louisiana, United States
Merz Investigational Site
New York, New York, United States
Merz Investigational Site
New York, New York, United States
Merz Investigational Site
New York, New York, United States
Merz Investigational Site
Nashville, Tennessee, United States
Countries
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References
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Pavicic T, Burgess C, Fabi S, Nestor MS, Bee EK, Imhof M, Dersch H, Sudimac V. Aesthetic Improvements Over Time: Long-Term Efficacy and Additional Outcomes of IncobotulinumtoxinA in the Simultaneous Treatment of Upper Facial Lines. J Cosmet Dermatol. 2025 Sep;24(9):e70460. doi: 10.1111/jocd.70460.
Joseph J, Sudimac V, Mersmann S, Kerscher M. IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results From Two Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. Aesthet Surg J. 2025 Feb 18;45(3):293-304. doi: 10.1093/asj/sjae222.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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M602011071
Identifier Type: -
Identifier Source: org_study_id
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