Drugs / Poly-L-Lactic Acid
Poly-L-Lactic Acid
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03858543 | Jul 2019 → Jan 2021 | dermis disorder | Henry Ford Health System | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07225348 | Nov 2025 → Jun 2026 overdue | — | Skincare Physicians of Chestnut Hill | Recruiting | No outcome recorded |
| Phase 4 | NCT01307865 | Jan 2011 → Jun 2012 | — | Williams Center Plastic Surgery Specialists | Completed | No outcome recorded |
| Phase 4 | NCT00447551 | Jan 2007 → Apr 2008 | skin atrophy | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07689344 | Jul → Aug 2026 overdue | skin atrophy | Institute of Dermatology, Thailand | Not yet recruiting | No outcome recorded |
| — | NCT07523217 | Mar 2024 → Mar 2027 expected | skin atrophy | Zagazig University | Recruiting | No outcome recorded |
| — | NCT02613481 | Nov 2015 → Jun 2017 | — | Yardley Dermatology Associates | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT07342452 Comparator | Jul 2026 → Apr 2027 expected | skin atrophy | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-04-09 | Galderma R&D | Results Interim data from two ongoing investigator-initiated trials highlight the role of Sculptra® and Restylane® in addressing aesthetic changes associated with weight loss medications and menopause galderma.com ↗
New interim results from a six-month investigator-initiated trial (IIT) supported by Galderma, regarding the clinical sequencing of women in menopause, show the combination of Restylane Skinboosters™ and Sculptra drove meaningful improvements in skin barrier function, hydration and patient satisfaction |
| 2026-01-22 | Galderma R&D | Results IMCAS 2026: Galderma showcases the latest scientific advances behind the industry’s broadest injectable aesthetics portfolio galderma.com ↗
Results from an expert review of data on Sculptra will also be presented, providing additional evidence of its regenerative properties. |
| 2025-12-05 | Galderma R&D | Regulatory Galderma opens up new chapter for Sculptra® with MDR certification and new expanded indication for body galderma.com ↗
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the certification of Sculptra for body indications in the European Union (EU) following its certification under the EU Medical Device Regulation (MDR). |
| 2025-11-17 | Galderma R&D | Results ASDS 2025: Compelling new data on Restylane, Sculptra and Relfydess highlight Galderma’s innovative Injectable Aesthetics portfolio and pipeline galderma.com ↗
Nine-month results from a first-of-its-kind clinical trial were presented, reinforcing that the treatment regimen of Restylane Lyft or Restylane Contour with Sculptra® delivers sustained aesthetic facial improvements for patients experiencing facial aesthetic changes after medication-driven weight loss4 |
| 2025-10-23 | Galderma R&D | Results Galderma delivers record net sales of 3.737 billion USD in the first nine months of 2025 and 15.0% year-on-year growth at constant currency, raises full-year guidance galderma.com ↗
Reinforced scientific leadership in dermatology, presenting new long-term data on Nemluvio, nine-month data on Restylane® and Sculptra® showing sustained results in addressing facial changes from medication-driven weight loss, and continuing investment in market-leading education |
| 2025-07-17 | Galderma R&D | Results Galderma unveils final nine-month data showing lasting efficacy and patient satisfaction with its Injectable Aesthetics portfolio when addressing facial aesthetic changes after medication-driven weight loss galderma.com ↗
Galderma has revealed positive final data from a phase IV first-of-its-kind trial exploring the benefits of Restylane Lyft or Contour in combination with Sculptra to address the aesthetic concerns of patients experiencing facial volume loss associated with medication-driven weight loss. |
| 2025-03-20 | Galderma R&D | Results AMWC 2025: Galderma pushes the innovation frontier with updates from its unparalleled portfolio designed to meet the needs of the aesthetic community galderma.com ↗
New in vivo data on Sculptra® (PLLA-SCA), the first proven regenerative biostimulator, will be presented, showing its lower inflammatory response compared to PLLA-GA, which can significantly impact local tissue response and product degradation and therefore may impact the duration of clinical effect3-12 |
| 2025-01-23 | Galderma R&D | Results IMCAS 2025: Galderma’s broad presence and new data on recently launched products Restylane® SHAYPE™ and Relfydess® reaffirm its category leadership galderma.com ↗
New data reinforce its robust regenerative properties and effects across all three skin layers, underscoring its key role in the regenerative aesthetics field, including its benefit in comparison to other products.19-21 |
| 2025-01-14 | Galderma R&D | Results Galderma premieres positive interim results demonstrating the efficacy of its Injectable Aesthetics portfolio in addressing facial volume loss as a result of medication-driven weight loss galderma.com ↗
Three-month interim data from first-of-its-kind trial demonstrate that the combination of Sculptra® and Restylane® Lyft™ or Contour™ effectively improved the facial aesthetic appearance of patients experiencing medication-driven weight loss with associated facial volume loss1 |
| 2024-11-04 | Galderma R&D | Results Celebrating 25 years of Sculptra®: new data and recent approval in China cements Galderma’s leadership in regenerative biostimulation galderma.com ↗
New data presented at this year’s American Society for Dermatologic Surgery Annual Meeting and published in the prestigious Journal of Drugs in Dermatology showcase Sculptra’s unique regenerative properties5-8 |
| 2024-10-17 | Galderma R&D | Results ASDS 2024: Galderma presents data on RelabotulinumtoxinA and Sculptra® galderma.com ↗
Galderma will be showcasing the latest data from its world-leading, science-based aesthetics portfolio at the American Society for Dermatologic Surgery (ASDS) 2024 Annual Meeting, held in Florida from October 17-20. |
| 2023-04-26 | Galderma R&D | Regulatory Galderma receives FDA approval for Sculptra® for cheek wrinkles galderma.com ↗
Galderma announced today that the U.S. Food and Drug Administration (FDA) has approved Sculptra® (injectable poly-L-lactic acid (PLLA-SCA)) for the correction of fine lines and wrinkles in the cheek area. |
| 2023-03-30 | Galderma R&D | Results AMWC 2023: Data from Sculptra® Cheek Wrinkle and Alluzience® Star Studies reinforce strength of Galderma’s broad aesthetic portfolio galderma.com ↗
Data from the innovative Sculptra Cheek Wrinkle study, a large clinical registration trial in the United States, show the long-lasting effectiveness of the treatment for cheek wrinkle correction over a two-year period. |
| 2023-01-20 | Galderma R&D | Results IMCAS 2023: Galderma to share latest data demonstrating high aesthetic improvement and patient satisfaction across its innovative portfolio galderma.com ↗
The results of the innovative Sculptra Cheek Wrinkle study, which were measured using state-of-the-art technology, show the early onset, long-lasting effectiveness and safety of the treatment for cheek wrinkle correction over 24 months. |
| 2022-10-07 | Galderma R&D | Results New data from Galderma's aesthetics portfolio to be presented at 2022 ASDS Annual Meeting galderma.com ↗
The study showed long-lasting efficacy out to month 12, with a Galderma Cheek Wrinkle Scales (GCWS at rest) responder rate of 71.6% and improved skin radiance, tightness and jawline contour (≥ 86%) |
| 2022-05-31 | Galderma R&D | Results Galderma to present extensive new clinical data across its portfolio of neuromodulators, fillers and biostimulators at the IMCAS World Congress 2022 galderma.com ↗
Presentation of the latest extension study for Sculptra®, the original poly-L-lactic acid (PLLA) which demonstrated it to be well-tolerated and with long-lasting effectiveness until week 96 using reconstituted 8mL dilution. |
| 2022-03-28 | Galderma R&D | Results Galderma to present new clinical data and high patient satisfaction across their portfolio of dermal fillers, collagen biostimulators and liquid neuromodulators at AMWC 2022 galderma.com ↗
The open-label extension study evaluating the new formulation of 8mL showed Sculptra® was well tolerated and had a long-lasting duration of effect, with subject satisfaction up to 96 weeks. |
| 2021-12-13 | Galderma R&D | Regulatory Galderma Receives FDA Approval for New SCULPTRA® Label, Offering More Options to Aesthetic Partners galderma.com ↗
The new label approved by the U.S. Food and Drug Administration (FDA) includes higher dilution, the addition of immediate use reconstitution, new injection techniques and the optional addition of lidocaine. |
All press releases naming this drug 22 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | poly-L-lactic acid | “Poly-L-Lactic Acid: A Comparative Study of Injectable and Thread-Based Delivery in Atrophic Acne Scars” NCT07523217 ↗7“injectable poly-L-lactic acid (PLLA, Sculptra®)” NCT07342452 ↗ |
| Known as | PLLA | “Poly-L-lactic acid (PLLA), a biostimulatory agent, promotes neocollagenesis and has emerged as a promising therapeutic option.” NCT07523217 ↗2“Poly-L-Lactic acid (PLLA) is used as a collagen-stimulating injectable for the treatment of neck skin laxity.” NCT07689344 ↗ “injectable poly-L-lactic acid (PLLA, Sculptra®)” NCT07342452 ↗ |
| Known as | Sculptra | “Poly-L-Lactic Acid (Sculptra™), a cosmetic product used to fill defects of the skin.” NCT02613481 ↗2“injectable poly-L-lactic acid (PLLA, Sculptra®)” NCT07342452 ↗ “Poly-L-Lactic Acid (Sculptra) injection” NCT07689344 ↗ |
| Action | Activate | “Poly-L-Lactic Acid (Sculptra™) stimulates collagen production in the skin” NCT02613481 ↗ |
| Modality | Small molecule | — CHEMBL6068621 ↗ |
| Route | Topical | “Topical PLLA diluted with 8cc of sterile water” NCT07225348 ↗ |