Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2019-11-12
2022-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Group A: Sculptra Aesthetic
Subjects in this group will be treated with Sculptra aesthetic. Subjects will be followed for up to 12 months for safety and effectiveness data collection
Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection
Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles
Group B: No Treatment
Subjects in this group will be followed for up to 12 months with no additional treatment for long-term safety and effectiveness data collection.
Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection
Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles
Interventions
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Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection
Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles
Eligibility Criteria
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Inclusion Criteria
2. Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent.
21 Years
ALL
Yes
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Galderma Research Site
Scottsdale, Arizona, United States
Galderma Research Site
Encino, California, United States
Galderma Research Site
Redondo Beach, California, United States
Galderma Research site
San Diego, California, United States
Galderma Research Site
Washington D.C., District of Columbia, United States
Galderma Research Site
Coral Gables, Florida, United States
Galderma Research Site
Alpharetta, Georgia, United States
Galderma Research Site
New Orleans, Louisiana, United States
Galderma Research Site
Rockville, Maryland, United States
Galderma Research Site
New York, New York, United States
Galderma Research Site
New York, New York, United States
Galderma Research Site
Dallas, Texas, United States
Galderma Research Site
Spring, Texas, United States
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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43USSA1812ext
Identifier Type: -
Identifier Source: org_study_id
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