Galderma Initiates Six New Studies, Increasing Company's Commitment to Aesthetic Research and Innovation
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:
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.
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
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® 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)
Are there other precautions that I should discuss with my doctor?
Tell your doctor if you have diseases, injuries, or disabilities of the hand.
What are the possible side effects?
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.
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