Restylane / Bausch Health - LARVOL DELTA

An epidemiologic assessment of FDA-reported complications of cosmetic injections, 2020-2024 (SID 2025) - "All entries over a 5-year period (1/1/2020 to 12/31/2024) were included for the following brands: Restylane, Juvéderm, and Sculptra...Product rheology and proprietary, brand specific factors are both implicated in adverse outcomes of cosmetic injections, particularly for risk of infection and vascular obstruction. Given that over 2.5 million soft tissue filler injections are performed annually across the United States and this number continues to rise, vigilant epidemiologic assessment is critical to identify risks of branded product lines in order to ensure safety in dermatologic care."

Clinical • Infectious Disease

Vocal Process Granulomas: Insights and Management (COSM 2025) - "Second-line treatments commonly included speech therapy (n=7) and Restylane injections (n=2), while third-line treatments utilized newer approaches such as Voluma injections (n=1), KTP laser (n=1), and fat augmentation (n=1)... Nineteen patients (15 male/4 female, average age 56.74±14.46 ranging from 34-79 years) were identified. Four presented with bilateral VPGs, while the remaining were unilateral. The most common first-line treatments were combination proton pump inhibitors (PPIs) and speech therapy (n=9), followed by inhaled corticosteroids (ICS) alone (n=8)."

Restylane Vocal Fold Augmentation: Assessing Safety and Duration of Efficacy (COSM 2025) - "Restylane is a safe and effective treatment for glottic insufficiency. Average benefit duration lasts 170 days, and many patients may experience ongoing benefits beyond."

Clinical • Gastrointestinal Disorder

Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects (clinicaltrials.gov) - P=N/A | N=50 | Completed | Sponsor: Galderma R&D | Active, not recruiting ➔ Completed

Trial completion

Effect of Recombinant Human Hyaluronidase on Conventional Hyaluronic Acid Fillers: An In Vitro Analysis. (PubMed, J Drugs Dermatol) - "This study demonstrates the in vitro response of different HA fillers to hyaluronidase. Each filler exhibited a variable dose effect. HA concentration (mg/mL) was the critical variable in determining the rate of hydrolysis. Therefore, HA concentration may be an important factor when calculating the dose of hyaluronidase needed to reverse HA fillers. J Drugs Dermatol. 2025;24(3):303-306. doi:10.36849/JDD.8428."

Journal • Preclinical

Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing (clinicaltrials.gov) - P=N/A | N=225 | Completed | Sponsor: Galderma R&D | Active, not recruiting ➔ Completed

Trial completion

Restylane Shaype Versus Juvederm Volux for Chin Augmentation (clinicaltrials.gov) - P=N/A | N=40 | Completed | Sponsor: Erevna Innovations Inc. | Active, not recruiting ➔ Completed

Trial completion

Comparative in-vitro degradation of hyaluronic acids exposed to different hyaluronidase enzymes. (PubMed, J Oral Biol Craniofac Res) - "Four commercially available HA were used: Lyft (Lt; Restylane, Galderma, Sweden), Voluma (Vol; Allergan, AbbVie, USA), UltraDeep (UDe; Rennova, Innovapharma, Brazil), and Subskin (Skn; Perfectha, Sinclair, France)...Furthermore, differences among HSE formulations do not appear to significantly impact HA degradation, while the mixing movement of HSE and HA seems to influence the degradation rate. These findings may help guide clinical decisions regarding the use of hyaluronidase in managing HA filler complications or adjustments."

Journal • Preclinical

Multimodal Pilot Evaluation of a Hyaluronic Acid Infraorbital Filler Using Precise, Multipositional, 3-Dimensional Imaging Quantification, Patient-Reported Outcomes, and Anatomic Cadaveric Assessments. (PubMed, Aesthet Surg J Open Forum) - "Juvéderm Vycross (Allergan Aesthetics, an AbbVie Company, Irvine, CA) and Restylane NASHA (Galderma, Lausanne, Switzerland) products were injected into the infraorbital and malar region in 6 cephalus specimens and evaluated with regards to the anatomic injection location with and without common clinical physical manipulations...Volbella XC effectively augments undereye volume to diminish infraorbital hollowing as measured over a 90-day period with significantly improved PROs. Enhanced knowledge of the behavior of Volbella XC and other HA fillers in this sensitive anatomic region will lead to improved patient outcomes."

Journal • Patient reported outcomes

Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies (clinicaltrials.gov) - P=N/A | N=40 | Active, not recruiting | Sponsor: Galderma R&D | Trial completion date: Oct 2024 ➔ May 2025 | Trial primary completion date: Oct 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Aesthetic Medicine

The efficacy and safety of crosslinked sodium hyaluronate gel for injection in correction of moderate and severe nasolabial creases were evaluated in a multicenter, randomized, controlled clinical trial (ChiCTR) - P=N/A | N=340 | Completed | Sponsor: Beijing Hospital; Shandong Danhong Pharmaceutical Co. Ltd.

New trial

Whole gland salvage prostate permanent implant with a rectal spacer in locally recurrent prostate cancer after radiation therapy : Getug P08 phase II study (EMUC 2024) - "A rectal spacer made of hyaluronic acid (HA) gel (Restylane® from Galderma, Uppsala) was injected into the rectoprostatic interface at the end of each implant...At last news, no patient had colostomy and 1 patient had urostomy, 4.9 years after sPPI. Conclusions Whole gland sPPI with a simultaneous integrated boost and a rectal spacer provides very low rates of late GI toxicity with only one third of salvage androgen deprivation in the long term."

P2 data • Genito-urinary Cancer • Infectious Disease • Oncology • Prostate Cancer • Solid Tumor • Urology

Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies (clinicaltrials.gov) - P=N/A | N=40 | Active, not recruiting | Sponsor: Galderma R&D | Recruiting ➔ Active, not recruiting

Enrollment closed • Aesthetic Medicine

A Multicenter, Randomized, Double-Blind, Parallel-Grouped, Positive-Controlled, Non-Inferiority Clinical Study to Evaluate the Efficacy and Safety of Injectable Calcium Hydroxylapatite Microsphere Hydrogel Fillers in the Correction of Nasolabial Fold in Chinese Subjects. (PubMed, Aesthetic Plast Surg) - "This study confirms that Aphranel is an effective and safe treatment for correcting NLFs in Chinese subjects."

Clinical • Head-to-Head • Journal • Pain

Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Nova Scotia Health Authority | N=40 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Trial withdrawal

Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies (clinicaltrials.gov) - P=N/A | N=40 | Recruiting | Sponsor: Galderma R&D

New trial • Aesthetic Medicine

Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion. (PubMed, J Drugs Dermatol) - "HASHA, a new NASHA-HD injectable with extra strength/firmness, was safe and effective for chin augmentation and correction of chin retrusion, with high aesthetic improvement and subject satisfaction throughout 12 months. J Drugs Dermatol. 2024;23(4):255-261.     doi:10.36849/JDD.8145."

Journal

A Multicenter, Randomized, Evaluator-Blinded Study to Examine the Safety and Effectiveness of Hyaluronic Acid Filler in the Correction of Infraorbital Hollows. (PubMed, Aesthet Surg J) - "HAEYE treatment was effective in correcting moderate/severe IOHs at the primary endpoint (Month 3). Efficacy was sustained through Month 12 after first treatment for 63.5% and through Month 18 for 80.3% (after one retreatment) with needle or cannula administration. Safety outcomes were reassuring."

Journal

Restylane Shaype Versus Juvederm Volux for Chin Augmentation (clinicaltrials.gov) - P=N/A | N=40 | Active, not recruiting | Sponsor: Erevna Innovations Inc.

New trial

RES: Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers (clinicaltrials.gov) - P=N/A | N=11 | Completed | Sponsor: Galderma R&D | Active, not recruiting ➔ Completed

Trial completion • Aesthetic Medicine

Clinical Perspectives on the Injectability of Cross-Linked Hyaluronic Acid Dermal Fillers: A Standardized Methodology for Commercial Product Benchmarking with Inter-Injector Assessments. (PubMed, Gels) - "Therefore, the present study comparatively assessed 28 cross-linked HA dermal fillers (JUVÉDERM®, Restylane®, BELOTERO®, TEOSYAL RHA®, and STYLAGE® brands) using various injectability benchmarking setups for enhanced clinical-oriented relevance...Generally, it was confirmed that each HA-based dermal filler product requires specific expertise for optimal injection, mainly due to differing viscoelastic characteristics and injectability attributes. Overall, the present study set forth evidence-based and clinical-oriented rationale elements confirming the importance for injectors to work with injectable products with which they are experienced and comfortable to optimize clinical results."

Journal • Aesthetic Medicine • Anesthesia

Simplifying the injector's armamentarium: An international consensus regarding the use of gel science to differentiate hyaluronic acid fillers and guide treatment recommendations. (PubMed, J Cosmet Dermatol) - "A majority consensus regarding the top NASHA versus OBT product choice for each anatomical region of the face was reached. These recommendations represent international agreement regarding the use of Restylane products."

Journal

Long-term Safety and Effectiveness of Hyaluronic Acid Fillers Correcting Nasolabial Folds in Chinese Patients. (PubMed, Plast Reconstr Surg Glob Open) - "The objective of this study was to investigate whether the effectiveness and safety of Belotero Volume Lidocaine (BVL) compared with Restylane (RES, control) is noninferior in the treatment of severe nasolabial folds (NLFs) in Chinese patients...The incidence rates of treatment-related AEs were low and very similar for both treatments. This study demonstrates that BVL is a safe, long-lasting, and effective treatment to correct severe NLFs in Chinese patients while being noninferior to the control device."

Journal • Pain

Connections between cohesion and properties that related to safety and effectiveness of the hyaluronic acid dermal fillers: A comparative study of the cohesive and non-cohesive gels. (PubMed, Skin Res Technol) - "Hyalumatrix is a rare HA filler product to possess good cohesion and intermediate G' simultaneously. More clinical practice is needed to verify the connection between the cohesion of Hyalumatrix and the clinical performance."

Journal • Aesthetic Medicine

Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing (clinicaltrials.gov) - P=N/A | N=225 | Active, not recruiting | Sponsor: Galderma R&D | Recruiting ➔ Active, not recruiting

Enrollment closed