Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles
NCT ID: NCT04124692
Last Updated: 2023-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
149 participants
INTERVENTIONAL
2019-11-12
2021-08-12
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
SINGLE
Study Groups
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Control Group: No-treatment
Participants will receive no treatment during the study.
No interventions assigned to this group
Treatment Group: Sculptra Aesthetic
Participants will be injected with Sculptra Aesthetic by Treating Investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions)
Sculptra Aesthetic new dilution
Treatment of cheek wrinkles
Interventions
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Sculptra Aesthetic new dilution
Treatment of cheek wrinkles
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:
1. Collagen, Hyaluronic Acid - 12 months
2. Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited
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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References
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Fabi SG, Le JHTD, Prygova I, Brasater D. Midface Projection Using Biostimulatory Poly- l -Lactic Acid Injectable Implant: A Subgroup Analysis of the Cheek Wrinkle Trial. Dermatol Surg. 2024 Dec 1;50(12):1137-1142. doi: 10.1097/DSS.0000000000004434. Epub 2024 Oct 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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43USSA1812
Identifier Type: -
Identifier Source: org_study_id
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