RALEIGH, N.C.--(BUSINESS WIRE)--Merz, a global leader in medical aesthetics, presented five-year follow-up data on Cellfina® System, which showed that a single treatment improved the appearance of cellulite on the thighs and buttocks for five years, building upon a previous study, which showed results lasting at least three years—the longest FDA clearance for a cellulite treatment. The pivotal study showed that, of the patients who completed the five-year follow up, evaluators rated 100% of the patients as having noticeable improvement after five years.1 The Cellfina® System is the only U.S. FDA-cleared and E.U. CE-Marked, minimally invasive procedure that effectively improves the appearance of cellulite.
“With this new five-year data, patients and physicians should feel confident that Cellfina® is the right step toward proven, noticeable and lasting results in the improved appearance of cellulite,” said Dr. Michael Kaminer, cosmetic surgeon and Cellfina® five-year study group member. “Creams and other cellulite treatments lead to limited patient satisfaction2, while Cellfina® patients experience enduring results. The study results confirm what we regularly see in practice.”
Approximately 85% of women have cellulite – uneven dimpled skin most often found on the thighs and buttocks, which is hard to control with diet and exercise alone and may impact self-esteem. 2 The primary structural cause of cellulite is the connective bands woven throughout fat in the thighs and buttocks. These tight bands pull down the skin, creating the puckering seen on the surface of the skin.
Merz also presented new guidelines for improving Ultherapy® Treatment results and patient satisfaction developed by a panel of expert aesthetic physicians called the Ultherapy® Treatment Consensus Group (Group). The Group, formed to provide physicians with a framework to customize their treatment approach, declared Ultherapy® the gold standard treatment for lifting and tightening skin on the chin, neck and chest.3
Ultherapy® is the only non-invasive treatment cleared by the FDA to actually lift skin. The treatment uses the body's own regenerative response to gently and gradually lift skin on the eyebrow, under the chin and on the neck, and smooth lines and wrinkles on the décolletage. It is also the only cosmetic procedure to use ultrasound imaging/visualization, which allows practitioners to see the layers of tissue targeted during the treatment to ensure the energy is deposited to where it will be most beneficial for skin lifting. The unique Ultherapy® technology is supported by more than 50 clinical studies and more than 60 published, peer-reviewed papers. The Group concluded that the use of ultrasound visualization is the single-most important factor for selecting optimal treatment depth to achieve ideal outcomes and increase patient satisfaction.
“The expert physician panel agreed that Ultherapy® is a key foundational aesthetic treatment and the gold standard for nonsurgical lifting of the skin,” said Dr. Sabrina Guillen Fabi, cosmetic dermatologist and lead author of the Ultherapy® consensus guidelines. “The guidelines extend the clinical data and valuable evidence available for physicians to be confident that treating patients with Ultherapy® leads to proven outcomes.”
The Group concluded that the use of ultrasound visualization is the single-most important factor for selecting optimal treatment depth to achieve ideal outcomes and increase patient satisfaction.
In addition to the two oral presentations, Merz will be presenting key updates on leading aesthetics products including:
- Diluted and Hyperdiluted Calcium Hydroxylapatite (RADIESSE®) for Skin Tightening: Guidelines from a Global Consensus Panel
- Comparison of XEOMIN® to botulinum neurotoxin type A formulations in Asia
- Escalating Doses of IncobotulinumtoxinA (XEOMIN®) for Extended Treatment of Glabellar Frown Lines: Results from a Randomized, Double-Blind Study
- The DESCRIBE® PFD Patch in Picosecond and Q-Switched Laser-Assisted Tattoo Removal: Safety in Fitzpatrick IV-VI Skin Types
“We are pleased to have a strong presence at the ASDS meeting with 15 data presentations,” said Dr. Kristina Yu-Isenberg, Vice President, North America Medical Affairs at Merz. “We are committed to delivering useful, relevant data to dermatologists and plastic surgeons to inform their practice and best meet the needs of the patients they treat.”
About Merz North America, Inc.
Merz North America, Inc. is a specialty healthcare company dedicated to the development and marketing of innovative quality products for physicians and patients across the United States and Canada. Merz products are distributed through two divisions, Aesthetics and Neurosciences, and are developed with the goal of improving patients’ health and quality of life by delivering therapies that bring about real progress. Privately-held, Merz North America is headquartered in Raleigh, North Carolina. To learn more about Merz North America, Inc., please visit www.merzusa.com.
About the American Society for Dermatologic Surgery (ASDS)
The American Society for Dermatologic Surgery (ASDS) is the largest specialty organization exclusively representing dermatologic surgeons who have unique training and experience to treat the health, function and beauty of your skin. ASDS members are pioneers in the field. Many are involved in the clinical studies that bring popular treatments to revitalize skin and fill and diminish wrinkles to the forefront. Their work has helped create and enhance many of the devices that remove blemishes, hair and fat, and tighten skin. Dermatologic surgeons also are experts in skin cancer prevention, detection and treatment. As the incidence of skin cancer rises, dermatologic surgeons are committed to taking steps to minimize the life-threatening effects of this disease. For more information, visit asds.net. Follow ASDS Skin MD on Facebook, Twitter and Instagram. Locate a dermatologic surgeon in your area: asds.net/find.
PLEASE SEE BELOW FOR THE IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use, is a prescription medicine that is used to treat adults with:
- chronic sialorrhea
- upper limb spasticity
- cervical dystonia
- blepharospasm who were previously treated with onabotulinumtoxinA (BOTOX®)
IMPORTANT SAFETY INFORMATION
WARNING: DISTANT SPREAD OF TOXIN EFFECT
See full prescribing information for complete BOXED WARNING.
The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
- Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted. XEOMIN is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
- Use in patients with an infection at the injection site could lead to severe local or disseminated infection. XEOMIN is contraindicated in the presence of infection at the proposed injection site(s).
WARNINGS AND PRECAUTIONS
- The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.
- Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
- Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN.
- Cervical Dystonia: Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post-marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia treated with botulinum toxin products. Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
- Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. Lower lid injections should not be repeated if diplopia occurred with previous botulinum toxin injections.
- XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and Creutzfeldt-Jakob disease (CJD). No cases of transmission of viral diseases or CJD have ever been reported for albumin.
Chronic Sialorrhea: The most commonly observed adverse reactions (incidence ≥3% of patients and greater than placebo) for XEOMIN were tooth extraction (5%), dry mouth (4%), diarrhea (4%), hypertension (4%), fall (3%), bronchitis (3%), dysphonia (3%), back pain (3%) and dry eye (3%).
Upper Limb Spasticity: The most commonly observed adverse reactions (incidence ≥2% of patients and greater than placebo) for XEOMIN were seizure (3%), nasopharyngitis (2%), dry mouth (2%), and upper respiratory tract infection (2%).
Cervical Dystonia: The most commonly observed adverse reactions (incidence ≥5% of patients and greater than placebo) for XEOMIN 120 Units and XEOMIN 240 Units, respectively, were: dysphagia (13%, 18%), injection pain site (9%, 4%), neck pain (7%, 15%), muscle weakness (7%, 11%), and musculoskeletal pain (7%, 4%).
Blepharospasm: The most commonly observed adverse reactions (incidence ≥5% of patients and twice greater than placebo) for XEOMIN were eyelid ptosis (19%), dry mouth (16%), dry eye (16%), visual impairment (12%), diarrhea (8%), headache (7%), dyspnea (5%) and nasopharyngitis (5%).
Co-administration of XEOMIN and aminoglycoside antibiotics or other agents interfering with neuromuscular transmission, e.g., tubocurarine-type muscle relaxants, should only be performed with caution as these agents may potentiate the effect of the toxin.
Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
USE IN PREGNANCY
There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established.
Copyright © 2018 Merz North America, Inc. All rights reserved. MERZ, the MERZ logo and XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA. Ultherapy and Cellfina are registered trademarks of Ulthera, Inc. Radiesse is a registered trademark of Merz North America, Inc. DeScribe is a registered trademark of ONLight Sciences, Inc.
|1. Kaminer, Michael. Multicenter Pivotal Study of the Safety and Effectiveness of a Tissue Stabilized-Guided Subcision Procedure for the Treatment of Cellulite - 5 Year Update. American Society for Dermatology Surgery Annual Meeting. October 11, 2018.|
|2. Sainio EL, Rantanen T, Kanerva L. Ingredients and safety of cellulite creams. Eur J Dermatol 2000;10:596-603|
|3. Fabi, Sabrina. Optimizing Patient Outcomes through a Customized Approach of Microfocused Ultrasound with Visualization Treatments: Consensus Guidelines from an Expert Panel. American Society for Dermatology Surgery Annual Meeting. October 11, 2018.|