Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
NCT ID: NCT04225260
Last Updated: 2023-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
902 participants
INTERVENTIONAL
2020-01-27
2021-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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QM1114-DP in the LCL and the GL areas
The investigational product (QM1114-DP) is a BoNT Type A.
At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines.
botulinum toxin neuromodulator
A dose of QM1114-DP will be injected in the GL area and in the LCL area.
Interventions
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botulinum toxin neuromodulator
A dose of QM1114-DP will be injected in the GL area and in the LCL area.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
* Female who is pregnant, breast feeding, or intends to conceive a child during the study.
* Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP) or any botulinum toxin serotype.
18 Years
ALL
Yes
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Investigate MD, LLC.
Scottsdale, Arizona, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Rejuva Medical Aesthetics, LLC
Los Angeles, California, United States
Westside Aesthetics
Los Angeles, California, United States
Marcus Facial Plastic Surgery
Redondo Beach, California, United States
The Maas Clinic Research Center
San Francisco, California, United States
ArteMedica
Santa Rosa, California, United States
AboutSkin Research, LLC
Greenwood Village, Colorado, United States
Modern Dermatology PC
Westport, Connecticut, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Steven Fagien, MD, PA
Boca Raton, Florida, United States
Susan H. Weinkle, M.D
Bradenton, Florida, United States
Miami Skin and Vein LLC
Coral Gables, Florida, United States
Mayoral Dermatology
Coral Gables, Florida, United States
Skin Research Institute, LLC
Coral Gables, Florida, United States
Research Institute of SouthEast, LLC
West Palm Beach, Florida, United States
Hamilton Research LLC
Alpharetta, Georgia, United States
Chicago Cosmetic Surgery and Dermatology, Inc
Chicago, Illinois, United States
Pure Dermatology, LLC
Metairie, Louisiana, United States
SkinCare Physicians
Chestnut Hill, Massachusetts, United States
Skin Laser and Surgery Specialist of NY/NJ
Hackensack, New Jersey, United States
Elite Aesthetic Research
Cincinnati, Ohio, United States
Aventiv Research, Inc.
Dublin, Ohio, United States
Dallas Plastic Surgery Institute
Dallas, Texas, United States
Center for Advanced Clinical Research
Dallas, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
SkinDC, PLLC
Arlington, Virginia, United States
EthiQ2 Research, LLC
Mequon, Wisconsin, United States
Jose Raul Montes Eyes & Facial Rejuvenation LLC
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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43QM1903
Identifier Type: -
Identifier Source: org_study_id
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