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NCT04595331 · ClinicalTrials.gov registry record · NA
Open Label Extension for 43USSA1812
A NA study of Wrinkle and Cheek, sponsored by Galderma R&D.
- Completed
- Registry status
- NA
- Development phase
- 111
- Enrollment target
- 13
- Study locations
NCT04595331: Completed NA study of Wrinkle and Cheek, sponsored by Galderma R&D.
NCT04595331 is a NA study of Wrinkle and Cheek that has completed, run by Galderma R&D. The registered enrollment target is 111 participants, roughly in line with the 116-participant average among 25 other Wrinkle trials with a reported enrollment target. The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04595331, a NA study of Wrinkle and Cheek, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- NA
- Development phase
- 111 participants
- Enrollment target
- 13
- Study locations
Study Summary
To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.
Primary Outcome
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on as scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
Interventions
- DEVICE Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection
Study Locations (13)
California
- Galderma Research Site - Encino
- Galderma Research Site - Redondo Beach
- Galderma Research site - San Diego
New York
- Galderma Research Site - New York
- Galderma Research Site - New York
Texas
- Galderma Research Site - Dallas
- Galderma Research Site - Spring
Arizona
- Galderma Research Site - Scottsdale
District of Columbia
- Galderma Research Site - Washington D.C.
Florida
- Galderma Research Site - Coral Gables
Georgia
- Galderma Research Site - Alpharetta
Louisiana
- Galderma Research Site - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2019-11-12 |
| Est. Completion | 2022-07-20 |
| Phase | NA |
What the finished NCT04595331 record still lists
NCT04595331 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 116-participant average among 25 other Wrinkle trials with a reported enrollment target.
The record links to 2 conditions, with Wrinkle appearing as the primary indexed condition, and to 1 intervention - of which Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection is the first listed.
NCT04595331 lists 13 locations in 9 states (California, New York, Texas).
Frequently Asked Questions
What is clinical trial NCT04595331 about?
NCT04595331 is a clinical study titled "Open Label Extension for 43USSA1812". To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.
What is the current status of trial NCT04595331?
This trial is currently completed. It is a NA study. The enrollment target is 111 participants. The study started on 2019-11-12. Estimated completion is 2022-07-20.
What conditions does trial NCT04595331 study?
This clinical trial studies the following conditions: Wrinkle, Cheek.
What interventions are being tested in trial NCT04595331?
The interventions under investigation include: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection (DEVICE).
Who is sponsoring clinical trial NCT04595331?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04595331 being conducted?
This trial has 13 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04595331's enrollment target sits among peer trials
111 8th of 25 higher than 18 of 25 other Wrinkle trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Wrinkle trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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