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NCT03780244 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
A NA study, sponsored by Galderma R&D.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT03780244: Completed NA study, sponsored by Galderma R&D.
NCT03780244 is a NA study that has completed, run by Galderma R&D. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03780244, a NA study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study has been designed to evaluate the 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 and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first
Interventions
- DEVICE Sculptra Aesthetic 8ml
- DEVICE Sculptra Aesthetic 5ml
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-12-18 |
| Est. Completion | 2020-02-28 |
| Phase | NA |
What the finished NCT03780244 record still lists
NCT03780244 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Sculptra Aesthetic 8ml is the first listed.
NCT03780244 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03780244 about?
NCT03780244 is a clinical study titled "Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.". This study has been designed to evaluate the 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 NCT03780244?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2018-12-18. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT03780244?
The interventions under investigation include: Sculptra Aesthetic 8ml (DEVICE), Sculptra Aesthetic 5ml (DEVICE).
Who is sponsoring clinical trial NCT03780244?
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 NCT03780244's enrollment target sits among peer trials
80 994th of 2000 higher than 941 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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