Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines
NCT ID: NCT03806933
Last Updated: 2023-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
241 participants
INTERVENTIONAL
2019-01-23
2020-10-08
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
DOUBLE
Study Groups
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NT 201 Dose group 1
Stage 1 and 2. Intramuscular injection into the glabellar area.
NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (NaCl).
NT 201 Dose group 2
Stage 1. Intramuscular injection into the glabellar area.
NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (NaCl).
NT 201 Dose group 3
Stage 1. Intramuscular injection into the glabellar area.
NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (NaCl).
NT 201 Dose group 4
Stage 2. Intramuscular injection into the glabellar area.
NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (NaCl).
NT 201 Dose group 5
Open Label Extension Period. Intramuscular injection into the glabellar area.
NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (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% unpreserved Sodium Chloride (NaCl).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by investigator on the 4-point facial wrinkle scale (FWS).
* Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by participant on the 4-point FWS.
Exclusion Criteria
* Previous treatment with any facial cosmetic procedure (example, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of eyebrows) in the glabellar area within the last 12 months before injection.
* Previous treatment with any biodegradable filler in the glabellar area within the last 12 months before injection.
* Inability to substantially reduce GFL by physically spreading them apart as assessed by the investigator.
* Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face.
* Any surgery or scars in the glabellar area.
* Marked facial asymmetry.
* Eyelid ptosis.
* Marked brow ptosis and/or dermatochalasis.
* Ongoing severe or unstable medical conditions, example, systemic infection, or pulmonary disease, at the discretion of the investigator.
18 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Merz Aesthetics GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz Pharmaceuticals GmbH
Locations
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Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
Encino, California, United States
Medical Associates Inc., Merz Investigational Site #0010435
Newport Beach, California, United States
Cosmetic Laser Dermatology, Merz Investigational Site #0010321
San Diego, California, United States
The Maas Clinics, Merz Investigational Site #0010338
San Francisco, California, United States
Tennessee Clinical Research Center, Merz Investigational Site #0010097
Nashville, Tennessee, United States
Privatpraxis für Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306
Berlin, , Germany
Universität Hamburg, Fachrichtung Kosmetik und Körperpflege, Merz Investigational Site #0490095
Hamburg, , Germany
Dermatologische Gemeinschaftspraxis Dr. Prager und Partner, Merz Investigational Site #0490345
Hamburg, , Germany
Skin & Laser Center, Merz Investigational Site #0490362
Potsdam, , Germany
Countries
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References
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Kerscher M, Fabi S, Fischer T, Gold M, Joseph J, Prager W, Rzany B, Yoelin S, Roll S, Klein G, Maas C. IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines. J Drugs Dermatol. 2021 Oct 1;20(10):1052-1060. doi: 10.36849/JDD.6377.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002743-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M602011015
Identifier Type: -
Identifier Source: org_study_id
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