Drugs / Restylane Silk
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03324997 | Jan 2018 | — | Heidi Waldorf | Withdrawn | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03460158 | Aug 2020 → Feb 2024 | — | University of Pennsylvania | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-11-22 | Galderma R&D | Results Galderma leads oral presentation on hyaluronic acid filler safety insights at ASDS 2021 Annual Meeting galderma.com ↗
Leveraging reports from the Manufacturer and User Facility Device Experience (MAUDE) database, the surveillance study analyzed delayed-onset (≥14 days) adverse events (AEs) of interest (inflammatory and non-inflammatory nodules, hypersensitivity, granulomas) for HA fillers FDA-approved between 2016-2020. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-11-22 | Galderma R&D | Galderma leads oral presentation on hyaluronic acid filler safety insights at ASDS 2021 Annual Meeting galderma.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Restylane Silk | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03324997 ↗ |
| Modality | Other / unclassified | “Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.” NCT03324997 ↗ |
| Route | Other | “submucosal implantation” NCT03460158 ↗ |