Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02425943 · ClinicalTrials.gov registry record · Phase 4
Sculptra Aesthetic Post-Approval Study
A Phase 4 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 867
- Enrollment target
NCT02425943: Completed Phase 4 study, sponsored by Galderma R&D.
NCT02425943 is a Phase 4 study that has completed, run by Galderma R&D. The registered enrollment target is 867 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02425943, a Phase 4 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 867 participants
- Enrollment target
Study Summary
Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.
Primary Outcome
Nodules and/or papules are a subset of AEIs that does not include hypertrophic scarring, keloid formation, changes in skin pigmentation at the site of injection compared to adjacent skin, granuloma (confirmed by a biopsy), skin necrosis, hypersensitivity reactions, and unexpected changes in wrinkle contour. Reporting of a nodule or papule was based on size (nodule greater than or equal to \[\>=\] 0.5 (cm); papule less than \[\<\] 0.5 cm). Percentage of participants with any injection site nodule
Interventions
- DEVICE injectable poly-L-lactic acid Sculptra Aesthetic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 867 participants |
| Start Date | 2015-05-21 |
| Est. Completion | 2021-05-28 |
| Phase | Phase 4 |
What the finished NCT02425943 record still lists
NCT02425943 is an interventional study that assigns participants to a tested intervention. The registered 867 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 1 intervention - of which injectable poly-L-lactic acid Sculptra Aesthetic is the first listed.
NCT02425943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02425943 about?
NCT02425943 is a clinical study titled "Sculptra Aesthetic Post-Approval Study". Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.
What is the current status of trial NCT02425943?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 867 participants. The study started on 2015-05-21. Estimated completion is 2021-05-28.
What interventions are being tested in trial NCT02425943?
The interventions under investigation include: injectable poly-L-lactic acid Sculptra Aesthetic (DEVICE).
Who is sponsoring clinical trial NCT02425943?
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 NCT02425943's enrollment target sits among peer trials
867 88th of 2000 higher than 1,913 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04933552 · 867 participants
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent
- NCT06077760 · 868 participants · Phase 3
A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
- NCT06822790 · 869 participants · Phase 3
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
- NCT05369052 · 865 participants · Phase 3
Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI