Restylane / Bausch Health - LARVOL DELTA

Galderma HA Filler Migration (clinicaltrials.gov) - P=N/A | N=10 | Recruiting | Sponsor: Erevna Innovations Inc.

New trial

Pan-Facial Layering of Hyaluronic Acid Filler (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Erevna Innovations Inc.

New trial • Aesthetic Medicine

The Price of Beauty: Analyzing Medical Malpractice Cases Related to Dermal Fillers (PSTM 2025) - "Silicone was the most frequently cited filler (n=4), followed by Juvederm, Radiesse, Restylane, and Sculptra (all n=3). Medical malpractice cases involving dermal fillers mainly favored defendants. Most defendants were aesthetic specialized physicians, though some lacked medical licenses or board certification in aesthetic specialties. Cases involving unqualified injectors or allegations of battery or fraud had higher odds of plaintiff verdicts or settlements."

Clinical • Aesthetic Medicine • Dermatology • Otorhinolaryngology

Who's Injecting You? Assessing Provider Credentials Among Manhattan's Aesthetic Injectors (PSTM 2025) - "First, providers were located through the "Find a Provider" feature on the official websites of dermal filler brands, including Bellafill, Juvederm, Radiesse, Restylane, RHA, Belotero, and Sculptra, with search parameters set to Manhattan, New York, and within a 5-mile radius. Our review of the top online results for aesthetic injectors in Manhattan reveals a wide variation in provider qualifications. Although most clinics are physician-owned, a notable number were founded by non-physicians that often lacked on-site doctor or employed non-aesthetic board certified specialists with limited credential transparency. These findings potentiate the need for greater regulatory oversight and consumer education in cosmetic injections."

Aesthetic Medicine • Dermatology • Otorhinolaryngology

Filler Up! Key Quality and Safety Considerations in Non-Cosmetic Applications of Soft-Tissue Fillers in Otolaryngology (AAO-HNSF 2025) - "Starting in 2003 with Restylane, hyaluronic acid (HA) fillers led the way, sparking a wave of innovation that now includes over 20 FDA-approved formulations for aesthetic use. Beyond hyaluronic acid, the filler market also includes calcium hydroxylapatite, poly-L-lactic acid, and polymethylmethacrylate microspheres, each with distinct properties tailored for specific applications.While fillers are well-established in cosmetic practices, their non-cosmetic applications are recently gaining more prominence in otolaryngology...Additionally, autologous fat grafting, as a potentially more permanent alternative, will be addressed. Panelists will also examine the potential risks associated with these products and discuss best practices for complication management.OUTCOME OBJECTIVE 1: Review the development, properties, and regulatory approval of various soft-tissue fillers and their implications for clinical use.OUTCOME OBJECTIVE 2: Examine the non-aesthetic applications of..."

Clinical • Aesthetic Medicine • Otorhinolaryngology

A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study of Restylane Skinboosters Vital Lidocaine (clinicaltrials.gov) - P=N/A | N=171 | Not yet recruiting | Sponsor: Galderma R&D

New trial

Alopecia Secondary to Hyaluronic Acid Injection: A Case Report and Literature Review. (PubMed, Clin Cosmet Investig Dermatol) - "A 23-year-old woman developed a 5×6.5 cm alopecic patch on the left temporal scalp just four days after receiving 5 mL of Restylane hyaluronic acid filler in the frontal area. Knowledge of scalp anatomy and injectable materials is essential. This case suggests that combining Concentrated Growth Factor, microneedling, and minoxidil may offer a promising therapeutic strategy for HA-induced alopecia."

Journal • Review • Aesthetic Medicine • Alopecia • Cardiovascular • Immunology • Inflammation

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