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(October 11, 2018)
FORT WORTH, Texas, Oct. 11, 2018 /PRNewswire/ -- Galderma Laboratories, L.P., a global leader focused on meeting the world's increasing skin health needs, has significantly increased its investment in research and innovation, initiating six new Phase III and IV U.S. aesthetic clinical trials.
"We are shaping the ever-evolving aesthetics industry like never before by developing new solutions to help drive consumers into aesthetic offices," said Alisa Lask, General Manager & Vice President of the U.S. Aesthetic Business at Galderma.
The company's R&D expansion also includes a significant increase in the number of women selected as clinical investigators. Since Galderma acquired the U.S. rights to Dysport® (abobotulinumtoxinA)*, Restylane®, and Sculptra® Aesthetic in 2014, the number of female clinical investigators in company-sponsored trials has more than doubled.
"We understand the vast majority of aesthetics consumers are women, so we have made a significant effort to increase the number of female investigators in our trials," said Xiaoming Lin, Global Head, Aesthetic Development at Galderma.
The six newly initiated studies include three pivotal trials evaluating XpresHAn Technology™ products; two studies for Dysport evaluating patient satisfaction and duration; and one study focusing on the unique properties of Sculptra Aesthetic (injectable poly-L-lactic acid).
"I am excited to partner with a company like Galderma who is continuing to invest in the aesthetics market and being thoughtful about the composition of their clinical trial investigator group," said Sue Ellen Cox, MD, founder and medical director of Aesthetic Solutions, Chapel Hill, NC and a primary investigator for Galderma's new trials.
As evidence of its ongoing dedication to advancing the field through scientific investigation, the company will present new data featuring its hyaluronic acid (HA) dermal filler, Restylane® Lyft during the 2018 American Society for Dermatologic Surgery (ASDS) Annual Meeting October 11-14 in Phoenix.
Restylane Lyft poster presentations will be showcased at ASDS, including a Phase III study that supported the recent FDA approval of Restylane Lyft for the treatment of age-related volume loss in the hands:
- A Prospective, Multi-Center, Randomized, Evaluator-Blinded, Split-Hand Study to Evaluate the Effectiveness and Safety of Large-Gel Particle Hyaluronic Acid with Lidocaine for the Correction of Volume Deficits in the Dorsal Hand – Dr. Joel Cohen (Poster #63, discussion and questions with the author Thursday Oct. 11, 5:30-6:00pm PT, outside the Exhibit Hall)
Galderma, Nestlé Skin Health's medical solutions business, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galdermausa.com and www.galderma.com.
To earn exclusive rewards, bonuses and discounts on Galderma's aesthetic treatments, join the ASPIRE Rewards program. To learn more about ASPIRE, visit www.aspirerewards.com.
*Please see full Important Safety Information, including Distant Spread of Toxin Effect Boxed Warning, at the end of this document
Important Safety Information Distant Spread of Toxin Effect
Dysport® is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.
Postmarketing reports indicate that the effects of Dysport and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including upper limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.
- Hypersensitivity to any botulinum toxin product or excipients
- Allergy to cow's milk protein
- Infection at the proposed injection site(s)
WARNINGS AND PRECAUTIONS
- The potency Units of Dysport are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of Dysport cannot be compared to or converted into units of any other botulinum toxin products.
- Recommended dose and frequency of administration should not be exceeded.
- Immediate medical attention may be required in cases of respiratory, speech or swallowing difficulties.
- Concomitant neuromuscular disorder may exacerbate clinical effects of treatment.
- Dysport contains human albumin. There is a risk for transmission of Creutzfeldt-Jakob disease (CJD) however, no cases of transmission of viral diseases or CJD have ever been identified for albumin.
- In clinical studies, the most frequently reported adverse events (?2%) were nasopharyngitis, headache, injection site pain, injection site reaction, upper respiratory tract infection, eyelid edema, eyelid ptosis, sinusitis, nausea, and blood present in urine.
- Concomitant use of Dysport and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of the botulinum toxin may be potentiated.
- Anticholinergic drugs may potentiate systemic anticholinergic effects.
- Excessive weakness may be exacerbated by administration of different botulinum neurotoxins and/or muscle relaxants during the course of treatment with Dysport.
USE IN SPECIFIC POPULATIONS
- Dysport is not recommended for use in children or pregnant women.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Dysport Full Prescribing Information including Medication Guide at DysportUSA.com.
Important Safety Information
The Restylane family of products includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Refyne, and Restylane® Defyne.
Restylane® and Restylane-L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated for injection into the lips in patients over the age of 21.
Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21. Restylane® Lyft with Lidocaine is also indicated for injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21.
Restylane® Silk is for lip augmentation and for correction of perioral wrinkles in patients over the age of 21.
Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.
Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.
Are there any reasons why I should not use products within the Restylane® family? (Contraindications)
To ensure a safe procedure, your doctor will talk to you about your medical history to determine if you are an appropriate candidate for treatment. You should not use products within the Restylane family if:
- You have severe allergies with a history of severe reactions (anaphylaxis)
- You are allergic to lidocaine or to any of the gram-positive bacterial proteins used to make hyaluronic acid
- You are prone to bleeding or have been diagnosed with a bleeding disorder
Are there other precautions that I should discuss with my doctor?
- Tell your doctor if you are breastfeeding, pregnant, or trying to become pregnant. The safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied
- Restylane, Restylane-L, Restylane® Lyft with Lidocaine, Restylane Refyne and Restylane Defyne are intended to treat facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are also intended for lip enhancement. Restylane® Lyft with Lidocaine is also intended for injection in the dorsal hand to correct volume loss. Treatments in other areas of the face or body have not been evaluated in clinical studies.
- The safety and effectiveness of Restylane® Silk for areas other than the lips and perioral area have not been evaluated in clinical studies.
- Tell your doctor if you have any history of scarring, particularly thick and stiff scars, or any pigmentation (skin color) disorders. These side effects can occur with hyaluronic acid fillers in general.
- Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
- Patients who experience skin injury near the site of injection with these products may be at a higher risk for side effects
- Tell your doctor if you are on any medications to decrease your body's immune response (immunosuppressive therapy). Using these medications may increase your risk of bruising or bleeding at the gel injection site.
- Tell your doctor if you are using any "blood thinners" such as aspirin, warfarin, or any other medications that affect bleeding. Using these medications may increase your risk of bruising or bleeding at the gel injection site.
- The use of these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of product in these areas could delay healing or make your skin problems worse.
Tell your doctor if you have diseases, injuries, or disabilities of the hand.
What are the possible side effects?
The most commonly observed side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. These are typically mild in severity and typically resolve in less than 7 days in nasolabial folds and less than 14 days in lips. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site.
One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin.
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any of the Restylane products, please call Galderma Laboratories, L.P at 1-855-425-8722.
The Restylane family of products is available only through a licensed practitioner. Complete Instructions for Use are available at www.RestylaneUSA.com.
Important Safety Information
Indication: Sculptra® Aesthetic (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems as a single regimen for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.
Sculptra® Aesthetic should not be used by people that are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Safety has not been established in patients who are pregnant, lactating, breastfeeding, or under 18 years of age.
Sculptra® Aesthetic has unique injection requirements and should only be used by a trained physician. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.
Sculptra® Aesthetic should not be injected into the blood vessels as it may cause vascular occlusion, infarction or embolic phenomena. Use at the site of skin sores, cysts, pimples, rashes, hives or infection should be postponed until healing is complete. Sculptra® Aesthetic should not be injected into the red area (vermillion) of the lip or in the peri-orbital area.
The most common side effects after initial treatment include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported.
Sculptra® Aesthetic is available only through a licensed practitioner. View the complete instructions for use at www.SculptraAesthetic.com.
© 2018 Galderma Laboratories, L.P.
All trademarks are the property of their respective owners.
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