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NCT04225273 · ClinicalTrials.gov registry record · NA
Extension Study for 43USSA1705
A NA study, sponsored by Galderma R&D.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT04225273: Completed NA study, sponsored by Galderma R&D.
NCT04225273 is a NA study that has completed, run by Galderma R&D. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04225273, a NA study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
To evaluate the long-term safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.
Primary Outcome
The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints. Lower scores indicate better outcome. Effectiveness is defined as change from baseline on both sides of the face using WAS at 72 and 96 weeks after the first treatme
Interventions
- DEVICE Sculptra Aesthetic, Lidocaine HCL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-12-03 |
| Est. Completion | 2021-01-29 |
| Phase | NA |
What the finished NCT04225273 record still lists
NCT04225273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Sculptra Aesthetic, Lidocaine HCL is the first listed.
NCT04225273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04225273 about?
NCT04225273 is a clinical study titled "Extension Study for 43USSA1705". To evaluate the long-term safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.
What is the current status of trial NCT04225273?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2019-12-03. Estimated completion is 2021-01-29.
What interventions are being tested in trial NCT04225273?
The interventions under investigation include: Sculptra Aesthetic, Lidocaine HCL (DEVICE).
Who is sponsoring clinical trial NCT04225273?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04225273's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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