Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
NCT ID: NCT04247074
Last Updated: 2023-09-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
413 participants
INTERVENTIONAL
2020-02-10
2021-02-26
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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QM1114-DP in the LCL + Placebo in the GL
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
botulinum toxin neuromodulator
QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL
Placebo
Placebo will be injected into either the LCL, GL, or both the LCL and GL
Placebo in the LCL and GL
A buffered solution; Mode of administration:
intramuscular injection
Placebo
Placebo will be injected into either the LCL, GL, or both the LCL and GL
Placebo in the LCL + QM1114-DP in the GL
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection
botulinum toxin neuromodulator
QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL
Placebo
Placebo will be injected into either the LCL, GL, or both the LCL and GL
QM1114-DP in the LCL + GL
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
botulinum toxin neuromodulator
QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL
Interventions
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botulinum toxin neuromodulator
QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL
Placebo
Placebo will be injected into either the LCL, GL, or both the LCL and GL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Moderate to severe LCL at maximum smile as assessed by the Investigator.
3. Moderate to severe LCL at maximum smile as assessed by the subject.
4. Moderate to severe GL at maximum frown as assessed by the Investigator.
5. 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).
18 Years
ALL
Yes
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Clinical Testing of Beverly Hills
Encino, California, United States
Ava MD
Santa Monica, California, United States
Skin Care & Laser Physicians of Beverly Hills
West Hollywood, California, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Baumann Cosmetic & Research Institute, Inc
Miami, Florida, United States
Washington Institute of Dermatologic Laser Surgery
Chevy Chase, Maryland, United States
Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Lorenc Aesthetic Plastic Surgery Center
New York, New York, United States
Elite Aesthetic Research
Cincinnati, Ohio, United States
The Westlake Dermatology Clinical Research
Austin, Texas, United States
Bertucci Medspa, Inc
Woodbridge, 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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43QM1902
Identifier Type: -
Identifier Source: org_study_id
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