Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2020-02-10
2021-01-05
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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Treatment
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
botulinum toxin
neuromodulator to be injected in the GL region
Placebo
A buffered solution; Mode of administration: intramuscular injection
Placebo
Placebo to be injected in the GL area
Interventions
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botulinum toxin
neuromodulator to be injected in the GL region
Placebo
Placebo to be injected in the GL area
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Moderate to severe GL at maximum frown as assessed by the Investigator.
3. Moderate to severe GL at maximum frown as assessed by the subject.
Exclusion Criteria
2. Female who is pregnant, breast feeding, or intends to conceive a child during the study.
3. 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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\Ablon Skin Institute and Research Center
Manhattan Beach, California, United States
Moradi MD
Vista, California, United States
Etre Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, United States
Maryland Dermatology, Laser Skin & Vein
Hunt Valley, Maryland, United States
Skin Specialist, PC
Omaha, Nebraska, United States
Robert Schwarcz, MD, PC
New York, New York, United States
Sachin M Shridharani, MD
New York, New York, United States
Wilmington Dermatology Center, PLLC
Wilmington, North Carolina, United States
The Practice of Brian S Biesman, MD
Nashville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Dallas Center for Dermatology & Aesthetics
Dallas, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Integrated Aesthetics, Inc
Spring, Texas, United States
Sweat Clinics of Canada
Toronto, Ontario, Canada
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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43QM1602
Identifier Type: -
Identifier Source: org_study_id
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