Restylane-L / Bausch Health - LARVOL DELTA

Long-Term Safety and Effectiveness of Cold-Crosslinked Hyaluronic Acid Fillers: Multicenter, Randomized, Controlled, Double-Blind Study. (PubMed, Aesthet Surg J) - "The new cold-crosslinked fillers were shown to be safe and effective for correction of nasolabial folds, with results lasting for 1 year."

Journal

Identifying Minimum Single Dose of Recombinant Human Hyaluronidase for In Vitro Dissolution of Twenty-Two Hyaluronic Acid Fillers. (PubMed, Ophthalmic Plast Reconstr Surg) - "This study identifies the minimum single dose of RHH from 2.5 units/0.2 ml to 140 units/0.2 ml for dissolution of 22 different hyaluronic acid fillers over 6 hours. These results paired with previous studies help elucidate the dissolution profiles of each filler in the context of their rheological properties, further informing physicians on how to optimally dissolve different hyaluronic acid fillers in a clinical setting."

Journal • Preclinical

A Large Prospective Volumetric and Patient-Reported Outcome Analysis Of Hyaluronic Acid Fillers to the Face. (PubMed, Plast Reconstr Surg) - "We define the novel tissue metrics, TDF and EV, relative to HA treatments, with greatest volume maintenance in the midface and greatest loss around the mimetic areas throughout 12 weeks. Significantly improved PROs were observed for patients undergoing large volume HA filler injections."

Journal

Prospective Evaluation of Facial Cosmetic Procedures (clinicaltrials.gov) - P4 | N=101 | Completed | Sponsor: University of Pennsylvania | Active, not recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ May 2024

Patient reported outcomes • Trial completion • Trial completion date • Aesthetic Medicine

Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin (clinicaltrials.gov) - P=N/A | N=15 | Recruiting | Sponsor: University of Michigan | Not yet recruiting ➔ Recruiting

Enrollment open

Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin (clinicaltrials.gov) - P=N/A | N=15 | Not yet recruiting | Sponsor: University of Michigan | Trial completion date: Nov 2025 ➔ Nov 2026 | Initiation date: Jan 2024 ➔ Apr 2024 | Trial primary completion date: Nov 2025 ➔ Nov 2026

Trial completion date • Trial initiation date • Trial primary completion date

Effectiveness and Safety of a Resilient Hyaluronic Acid Filler Versus Restylane-L® For Lip Augmentation (AAD 2024) - "RHA® 3 is safe and effective for lip augmentation, with high patient satisfaction and a favorable safety profile, while remaining non-inferior to Restylane-L®."

Clinical • Pain

Prospective Evaluation of Facial Cosmetic Procedures (clinicaltrials.gov) - P4 | N=101 | Active, not recruiting | Sponsor: University of Pennsylvania | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2023 ➔ Feb 2024 | Trial primary completion date: Aug 2023 ➔ Feb 2024

Enrollment closed • Patient reported outcomes • Trial completion date • Trial primary completion date • Aesthetic Medicine

Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin (clinicaltrials.gov) - P=N/A | N=15 | Not yet recruiting | Sponsor: University of Michigan

New trial

Response of 21 Hyaluronic Acid Fillers to Recombinant Human Hyaluronidase. (PubMed, Plast Reconstr Surg Glob Open) - "Restylane Lyft, Restylane-L/Eyelight, and Resilient Hyaluronic Acid (RHA) 1/Redensity were the least resistant. The moderately resistant group comprised of Restylane Silk, Juvéderm Volbella, Revanesse Versa/Lips, and Belotero Balance on the less resistant side to Juvéderm Vollure, RHA 2, Restylane Contour, Juvéderm Ultra, Restylane Refyne, Belotero Intense, Restylane Kysse, RHA 3, Juvéderm Ultra Plus, and Restylane Defyne on the more resistant side...With the increasing popularity of fillers comes the increasing need to dissolve them for both ischemic and nonischemic complications. The majority of hyaluronic acid fillers available on the market are very resistant to hyaluronidase, which must be considered when determining the amount of hyaluronidase to dissolve a particular filler."

Journal

RHA® 3 Versus Restylane-L® for Lip Augmentation (clinicaltrials.gov) - P=N/A | N=202 | Completed | Sponsor: Teoxane SA | Withheld ➔ Completed

Trial completion

Restylane-L for Correction of Infraorbital Hollows (clinicaltrials.gov) - P=N/A | N=329 | Completed | Sponsor: Galderma R&D | Active, not recruiting ➔ Completed

Trial completion

Prospective Evaluation of Facial Cosmetic Procedures (clinicaltrials.gov) - P4; N=100; Recruiting; Sponsor: University of Pennsylvania; Trial completion date: May 2022 ➔ Aug 2022; Trial primary completion date: Jan 2022 ➔ Jun 2022

Clinical • Patient reported outcomes • Trial completion date • Trial primary completion date • Aesthetic Medicine

Prospective Evaluation of Facial Cosmetic Procedures (clinicaltrials.gov) - P4; N=100; Recruiting; Sponsor: University of Pennsylvania; Trial completion date: Nov 2021 ➔ May 2022; Trial primary completion date: Sep 2021 ➔ Jan 2022

Clinical • Patient reported outcomes • Trial completion date • Trial primary completion date • Aesthetic Medicine

Response of twelve different hyaluronic acid gels to varying doses of recombinant human hyaluronidase. (PubMed, J Plast Reconstr Aesthet Surg) - "This study visually and objectively demonstrates the in vitro response of HA to dissolution by hyaluronidase. Fillers were categorized into least, moderate, and most resistant to RHH. Interesting findings include markedly different degrees of liquefaction for products used for similar indications (such as Restylane Lyft being more liquefied than Voluma), and Belotero easily flattening but retaining texture. Combined with in vivo data, this may help calculate hyaluronidase doses needed for controlled, partial reversal of commercially available HA gels."

Journal

Restylane-L for Correction of Infraorbital Hollows (clinicaltrials.gov) - P=N/A; N=329; Active, not recruiting; Sponsor: Q-Med AB; Recruiting ➔ Active, not recruiting; Trial completion date: Sep 2021 ➔ Apr 2022; Trial primary completion date: Aug 2021 ➔ Jan 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

Prospective Evaluation of Facial Cosmetic Procedures (clinicaltrials.gov) - P4; N=100; Recruiting; Sponsor: University of Pennsylvania; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Aesthetic Medicine

Restylane-L for Correction of Infraorbital Hollows (clinicaltrials.gov) - P=N/A; N=315; Recruiting; Sponsor: Q-Med AB; N=238 ➔ 315

Enrollment change

Effects of Restylane-L® Filler Injection for Non-Surgical Rhinoplasty (clinicaltrials.gov) - P1; N=10; Completed; Sponsor: DeNova Research; Not yet recruiting ➔ Completed; Initiation date: Dec 2019 ➔ Jan 2019; Trial primary completion date: Apr 2020 ➔ Jul 2020

HEOR • Trial completion • Trial initiation date • Trial primary completion date • Aesthetic Medicine

Prospective Evaluation of Facial Cosmetic Procedures (clinicaltrials.gov) - P4; N=100; Not yet recruiting; Sponsor: University of Pennsylvania; Trial completion date: May 2021 ➔ Nov 2021; Trial primary completion date: Jun 2020 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date

Pain and Safety of Restylane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds (clinicaltrials.gov) - P=N/A; N=70; Completed; Sponsor: Q-Med AB; Recruiting ➔ Completed

Trial completion • Biosimilar • CNS Disorders • Pain

Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars (clinicaltrials.gov) - P4; N=51; Active, not recruiting; Sponsor: Q-Med AB; Recruiting ➔ Active, not recruiting; Trial primary completion date: Dec 2017 ➔ Mar 2018

Enrollment closed • Trial primary completion date • Biosimilar

Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars (clinicaltrials.gov) - P4; N=60; Recruiting; Sponsor: Q-Med AB; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar

A Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine (clinicaltrials.gov) - P=N/A; N=12; Active, not recruiting; Sponsor: Q-Med AB; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar

Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars (clinicaltrials.gov) - P4; N=60; Not yet recruiting; Sponsor: Q-Med AB

New P4 trial • Biosimilar