Last update 19 Sep 2024
Retrognathia
Last update 19 Sep 2024
Basic Info
Synonyms Retrognathia, Retrognathias, 上顎後退症 + [13] |
Introduction A physical misalignment of the upper (maxilla) and lower (mandibular) jaw bones in which either or both recede relative to the frontal plane of the forehead. |
Related
12
Clinical Trials associated with RetrognathiaMaxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery: A Quality Assessment by Novel Automated Virtual Methods
Orthognathic surgery is a type of jaw surgery where a surgeon cuts the bones of the upper and lower jaw and places them better. There are two ways they can put the bones in the correct place and keep them in place after the surgery. One way, called the "conventional method", is to use a 3D-printed guide called a splint to set the bones in the right place and then screw the bones together using metal plates that the surgeon bends into shape to fit during the surgery. Another way is to use a patient-specific implants (PSI) that has been 3D-printed in titanium beforehand that because of its unique shape both places and keeps all the bones in the correct place after they are screwed in. Both ways of doing it are golden standards, meaning they are already approved.
Measuring the accuracy of the surgery is done by comparing the positions of the bones after the surgery with the intended positions of those bones, according to the surgical plan. The closer the achieved position of each bone is to the intended position, the more accurate the result.
Measuring the stability of the surgery is done by comparing the positions of the bones after the surgery with the positions of the bones two years later. The less the position is changed, the more stable the result.
The goal of this clinical trial is to see how accurate and stable PSIs are in orthognathic surgery when the maxilla is split in 3 pieces, and to compare them with the conventional method in patients with overjet or overbite. The main questions it aims to answer are:
Does using PSIs provide accurate movements of the maxilla pieces?
Does using PSIs provide more accurate movements of the maxilla pieces than the conventional method?
Does using PSIs provide stable movements of the maxilla pieces after 2 years?
Does using PSIs provide more stable movements of the maxilla pieces than the conventional method?
Participants will get orthognathic surgery as part of their normal orthodontic treatment.
Investigators will compare the PSI and conventional groups to see if the PSIs are more accurate than the conventional method.
Measuring the accuracy of the surgery is done by comparing the positions of the bones after the surgery with the intended positions of those bones, according to the surgical plan. The closer the achieved position of each bone is to the intended position, the more accurate the result.
Measuring the stability of the surgery is done by comparing the positions of the bones after the surgery with the positions of the bones two years later. The less the position is changed, the more stable the result.
The goal of this clinical trial is to see how accurate and stable PSIs are in orthognathic surgery when the maxilla is split in 3 pieces, and to compare them with the conventional method in patients with overjet or overbite. The main questions it aims to answer are:
Does using PSIs provide accurate movements of the maxilla pieces?
Does using PSIs provide more accurate movements of the maxilla pieces than the conventional method?
Does using PSIs provide stable movements of the maxilla pieces after 2 years?
Does using PSIs provide more stable movements of the maxilla pieces than the conventional method?
Participants will get orthognathic surgery as part of their normal orthodontic treatment.
Investigators will compare the PSI and conventional groups to see if the PSIs are more accurate than the conventional method.
Start Date12 Sep 2023 |
Sponsor / Collaborator |
Digitally Fabricated Inter-occlusal Wafer Versus Wafer-less Distal Segment Repositioning for Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformities (Randomized Controlled Trial)
Research studies continues to attempt testing modifications to refine the treatment protocols through computer assisted design or computer-generated surgical Wafer splints, have greatly revolutionized the incorporation of digital imaging and 3D design in Orthognathic surgery.
Integrating computer guided technology in orthognathic surgery aims to to simplify workup and reduce surgical errors, eliminate occlusal discrepancy, increase the realignment accuracy of the distal segments according to the preoperative plan. Implementing a waferless technique raised the question of efficiency versus the use of occlusal wafers and whether it has a significant measurable effect on the surgical outcome and objectives.
Rationale for conducting this study is to assess the difference between the effect of computer guided waferless technique and computer guided technique with occlusal wafer on accuracy of postoperative occlusion and condylar position.
.
Integrating computer guided technology in orthognathic surgery aims to to simplify workup and reduce surgical errors, eliminate occlusal discrepancy, increase the realignment accuracy of the distal segments according to the preoperative plan. Implementing a waferless technique raised the question of efficiency versus the use of occlusal wafers and whether it has a significant measurable effect on the surgical outcome and objectives.
Rationale for conducting this study is to assess the difference between the effect of computer guided waferless technique and computer guided technique with occlusal wafer on accuracy of postoperative occlusion and condylar position.
.
Start Date15 Nov 2021 |
Sponsor / Collaborator |
Evaluation of surgical outcomes of patients treated with the Surgery First Approach and Aligners
Start Date10 Jan 2021 |
Sponsor / Collaborator |
100 Clinical Results associated with Retrognathia
Login to view more data
100 Translational Medicine associated with Retrognathia
Login to view more data
0 Patents (Medical) associated with Retrognathia
Login to view more data
456
Literatures (Medical) associated with Retrognathia20 Feb 2024·Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine
Use of At-Breast Supplementers to Facilitate Feeding Solely at the Breast for Infants with Retrognathia: Two Case Studies.
Article
Author: Moira Haggarty Edwards ; Daphne Doble ; Laura Ball ; M Elise Graham
Objective: Infants with significant retrognathia often have difficulty forming a latch adequate to establish exclusive breastfeeding. This article describes the use of at-breast supplementers (ABSs) to facilitate extended breastfeeding relationships, even when supplementation is necessary for growth. Methods: Two cases are described where infants with severe retrognathia initially struggled with weight gain necessitating supplementation but were able to ultimately exclusively feed at-breast with the use of ABSs. Results: While the two cases differed in the form of supplemental milk used and duration of ABS use, both dyads breastfed for beyond 2 years. Conclusions: Feeding solely at the breast and subsequent extended breastfeeding may be possible even for infants who require supplementation, including those with anatomical or functional challenges such as retrognathia. The ABS is a relatively simple system that may be beneficial for difficulties such as poor latch and low milk supply. More awareness and education is needed so that clinicians consider supporting dyads with this approach.
30 Dec 2023·BMJ case reports
Thurston syndrome with thalassaemia: a rare case devising a novel molecular and phenotypic variation.
Article
Author: Aswanth Ks ; Adity Bansal ; Prashant Kumar Verma ; Nowneet Kumar Bhat
A male infant presented with progressive paleness of the body since 3 months of age. On examination, the child had pallor, microcephaly with dysmorphic facies (depressed nasal bridge, low set ears, retrognathia, high arched palate and tongue hamartoma). Postaxial polydactyly in bilateral hands and feet, broad great toes, with syndactyly of left fourth and fifth toes were present. The haemogram showed severe anaemia with a microcytic hypochromic picture. High-performance liquid chromatography (HPLC) was normal. However, the parents' HPLC was suggestive of beta thalassaemia trait. Whole-exome sequencing revealed Thurston syndrome with beta-thalassaemia in homozygous pattern with a novel mutation. It is a rare genetic syndrome exclusively found in the South Asian population. Due to the rarity, identification of this syndrome is often difficult and requires awareness among clinicians. However, it is important to diagnose the disorder accurately in order to provide appropriate genetic counselling and prognostication to the parents.
01 Apr 2023·Current opinion in obstetrics & gynecology
Understanding the distinction between cleft lip and cleft palate: a critical step for successful prenatal detection.
Review
Author: Kathleen Minor ; Jane Chueh
PURPOSE OF REVIEW:
Orofacial clefts (OCs) are among the most common congenital anomalies, however, prenatal detection of cleft palate without cleft lip (CP) remains low. CP is associated with a higher risk of associated structural anomalies, recurrence risk and genetic aberrations. There is opportunity to optimize prenatal diagnosis, counseling and diagnostic genetic testing for OCs.
RECENT FINDINGS:
Improving prenatal diagnosis of CP requires understanding that embryologically, the secondary palate develops from the 6th to the 10th week and fuses with the primary palate by the 12th week. Multiple first, second and third trimester 2D ultrasonographic markers for OCs have been described including the maxillary gap, frontal space, maxilla-nasion-mandible angle, retronasal triangle, palatino-maxillary diameter, equal sign, nonvisualization or gap in the soft to hard palate interface and loss of the superimposed line. We discuss the technique, evidence and limitations of each.
SUMMARY:
Prenatal detection of OC can be optimized by employing 2D sonographic markers. Prenatal detection of CP may be improved by recognizing its high association with retrognathia/micrognathia.
2
News (Medical) associated with Retrognathia28 Nov 2022
For the first time at SCOPE Miami Beach, Galderma, a leader in advancing the future of aesthetics, will invite attendees to explore its portfolio of injectable treatments
DALLAS, Nov. 28, 2022 /PRNewswire/ -- Galderma announced today its upcoming collaboration with SCOPE Miami Beach 2022, the premier showcase for emerging contemporary art. As the exclusive aesthetic injectables sponsor of the 21st annual art show, Galderma will be highlighting its aesthetics portfolio – Restylane®, Dysport®* (abobotulinumtoxinA) and Sculptra® – and hosting a variety of activations for visitors beginning November 29th through December 4th, 2022.
"We are thrilled to be among the artists and innovators at SCOPE Miami Beach this year," said Carrie Caulkins, Vice President, U.S. Aesthetics Marketing, Galderma. "Every skin story begins with a beautiful canvas and this partnership serves as a great reminder that expression can come in many forms."
During the showcase, Galderma will create an interactive space for guests, celebrating the beauty of art and aesthetics via a custom art installation from renowned street artist, HOTTEA. Brand representatives onsite will provide information about Restylane, Dysport and Sculptra and the booth will offer personalized consultations and real-time treatments with Miami-based aesthetic injectors, custom beauty tips and touchups from a celebrity makeup artist. Guests will be able to enjoy a coffee bar featuring latte art and participate in giveaways and meet and greets with A-list influencers throughout the week. Guests can also receive up to $200 off Galderma Aesthetics treatments through a special ASPIRE Galderma Rewards offer.**
"Self-expression is a cornerstone of art," Caulkins said. "A recent study*** found that the majority of consumers find it important to be able to visually express themselves, which is why, at Galderma, we embrace and encourage self-expression through the art of aesthetics. We strive to innovate and deliver products that allow patients to fully express a range of emotions, while looking their best."
Galderma's presence at SCOPE Miami Beach 2022 builds on the momentum of Restylane's "XpresYourself" communications campaign, aimed at destigmatizing aesthetics and promoting natural-looking results. The brand's proprietary XpresHAn Technology™, a unique manufacturing process used to formulate four Restylane products****, allows for natural movement and expression.1-3 Dysport and Sculptra are also designed to provide natural-looking results, giving consumers a portfolio of products to choose from. SCOPE Art Show's mission to provide a platform for experiential innovation and discovery complements Galderma's commitment to design innovative and effective aesthetic treatments with natural-looking results for every laugh, smile and expression.
For those unable to join Galderma at SCOPE Miami Beach 2022, check out RestylaneUSA, DysportUSA and SculptraUSA on Instagram to follow the conversation.
To learn more about Galderma's portfolio, visit .
*Please see full Important Safety Information for Dysport, including Distant Spread of Toxin Effect Boxed Warning, below.
**Terms and conditions apply. For details, visit ASPIRE Galderma Rewards.
***Results based on a nationwide online survey conducted by Real Chemistry of 1,000 directionally representative aesthetically conscious consumers in the U.S.
****Products formulated with XpresHAn Technology™ include Restylane® Contour, Restylane® Kysse, Restylane® Defyne and Restylane® Refyne.
About Galderma
Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story. For more information: .
About Galderma's RESTYLANE® Product Portfolio
With over 50 million treatments worldwide4 and counting, the Restylane® family of HA dermal fillers is a diverse and broad portfolio of dermal fillers in the U.S. These products help smooth facial wrinkles and folds, such as smile lines (Restylane® L, Restylane® Refyne, Restylane® Defyne and Restylane® Lyft with Lidocaine), augment and correct mild to moderate chin retrusion (Restylane® Defyne), create fuller and more accentuated lips (Restylane® Silk, Restylane®-L and Restylane® Kysse), add lift and volume to the cheeks and back of the hands (Restylane® Lyft with Lidocaine), and augment cheeks and correct midface contour deficiencies (Restylane® Contour). To learn more about the Restylane® family of HA dermal fillers, visit .
About Galderma's collaboration with Ipsen
Dysport® (abobotulinumtoxinA) is a prescription injection for temporary improvement in the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Dysport is also marketed as Azzalure in the EU for the treatment of glabellar lines and lateral canthal lines. Dysport has more than 30 years of clinical experience globally for therapeutic indications and 13 years for aesthetics indications, with extensive clinical evidence of safety and efficacy. It is li-censed for aesthetic indications in 85 markets5 worldwide, Dysport is one of the world's leading brands of aesthetic neuromodulators with over 100 million treatments delivered in the aesthetics indications to date. To learn more about Dysport products, visit .
Dysport is manufactured by Ipsen, a global specialty-driven pharmaceutical company. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen's botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, the European Union, Australia, South Korea, Canada, Brazil, Argentina and certain other countries. Ipsen continues to promote Dysport within certain therapeutic indications in countries around the world. For more information on Ipsen, visit .
About SCULPTRA®
Sculptra® works to help stimulate the skin's own collagen production and is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.6,7 Sculptra is an injectable biostimulator containing microparticles of poly-l-lactic acid (PLLA) which helps gradually revitalize the skin's structural foundation, providing natural-looking, long-term results for up to 2 years.6† Sculptra was first approved for aesthetic use in 2009 in the United States and is currently available in more than 40 countries globally. To learn more about Sculptra products, visit .
† Clinical study ended at 96 weeks (2 years)
To earn exclusive rewards, bonuses and discounts on Galderma's aesthetic treatments, join the ASPIRE Galderma Rewards program. To learn more, visit .
Media
Zach Randles-Friedman
Head of U.S. Communications
[email protected]
+1 (305) 299-5700
DYSPORT IMPORTANT SAFETY INFORMATION
Dysport® (abobotulinumtoxinA) 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.
Important Safety Information
What is the most important information you should know about Dysport? Spread of Toxin Effects: In some cases, the effects of Dysport and all botulinum toxin products may affect areas of the body away from the injection site. Symptoms can happen hours to weeks after injection and may include swallowing and breathing problems, loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, or loss of bladder control. Swallowing and breathing problems can be life threatening and there have been reports of death. You are at the highest risk if these problems are pre
‐
existing before injection.
These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.
Do not have Dysport treatment if you: are allergic to Dysport or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow's milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®, have a skin infection at the planned injection site, under 18 years of age, or are pregnant or breastfeeding.
The dose of Dysport is not the same as the dose of any other botulinum toxin product and cannot be compared to the dose of any other product you may have used.
Tell your doctor about any swallowing or breathing difficulties and all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis, or Lambert‐Eaton syndrome, which may increase the risk of serious side effects including difficulty swallowing and difficulty breathing. Serious allergic reactions have occurred with the use of Dysport. Dry eye has also been reported.
Tell your doctor about all of your medical conditions, including if you have surgical changes to your face, very weak muscles in the treatment area, any abnormal facial change, injection site inflammation, droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, wrinkles that can't be smoothed by spreading them apart, or if you are pregnant or breastfeeding or planning to become pregnant or breastfeed.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects.
Do not start any new medicines while taking Dysport without talking to your doctor first.
Especially tell your doctor if you: have received any other botulinum toxin product, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA), in the last four months or any in the past (be sure your doctor knows exactly which product you received, have recently received an antibiotic by injection, take muscle relaxants, take an allergy or cold medicine, or take a sleep medicine.
Common Side Effects
The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea.
Ask your doctor if Dysport is right for you.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
Please see Dysport Full Prescribing Information including Medication Guide at DysportUSA.com.
RESTYLANE IMPORTANT SAFETY INFORMATION
The Restylane family of products are indicated for patients over the age of 21, and includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Kysse, Restylane® Refyne, Restylane® Defyne, and Restylane® Contour.
APPROVED USES
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.
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. Restylane® Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss.
Restylane® Silk is for lip augmentation and for correction of perioral wrinkles.
Restylane® Kysse is for lip augmentation and for correction of upper perioral wrinkles.
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.
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. Restylane® Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.
Restylane® Contour is for cheek augmentation and for the correction of midface contour deficiencies.
Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), are allergic to lidocaine or gram-positive bacterial proteins used to make hyaluronic acid, prone to bleeding, or have a bleeding disorder. The safety of use while pregnant or breastfeeding has not been studied. Tell your doctor if you have a history of scarring or pigmentation disorders as these side effects can occur with hyaluronic acid fillers. Tell your doctor if you are planning other cosmetic treatments (i.e., lasers and chemical peels) as there is a possible risk of inflammation at the injection site.
Tell your doctor if you're taking medications that lower your body's immune response or affect bleeding, such as aspirin or warfarin, as these medications may increase the risk of bruising or bleeding at the gel injection site. Using these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete.
The most common side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. The risk of unintentional injection into a blood vessel is small but can occur and could result in serious complications, which may be permanent including, 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 Restylane® product, please call Galderma Laboratories, L.P. at 1-855-425-8722.
To learn more about serious but rare side effects and full Important Safety Information, visit .
SCULPTRA
IMPORTANT SAFETY INFORMATION
Indication: Sculptra® (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.
Sculptra 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 has unique injection requirements and should only be used by a trained healthcare practitioner. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.
Sculptra 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 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 is available only through a licensed practitioner. Complete Instructions for Use are available at .
References:
Philipp-Dormston WG, Schuster B, Podda M. Perceived naturalness of facial expression after hyaluronic acid filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19:1600-16064.
Öhrlund Å. Evaluation of rheometry amplitude sweep cross-over point as an index of flexibility for HA fillers. JCDSA.2018;8:47-54.
Data on file. MA-34483 Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2021.
Data on file. MA-39680. Fort Worth, TX: Galderma Laboratories, L.P., 2019.
Data on file. Ipsen World-Wide Marketing Authorisation Status. Fort Worth, TX: Galderma Laboratories, L.P., February 2017.
Sculptra. Instructions for Use. Galderma Laboratories, L.P., 2021.
Goldberg D, Guana A, Volk A, Daro-Kaftan E. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39(6):915-922.
© 2022 Galderma Laboratories, L.P. The Dysport® trademark is used under license. All trademarks are the property of their respective owners. US-DYS-2200244
SOURCE Galderma
Drug Approval
23 Jun 2022
Join Restylane®, Dysport® and Sculptra® at PrideFest 2022
FORT WORTH, Texas, June 23, 2022 /PRNewswire/ -- Galderma announced today its upcoming participation in New York City's official LGBTQIA+ Pride (NYC Pride) event. The company's aesthetics portfolio, inclusive of the award-winning brands Restylane®, Dysport® (abobotulinumtoxinA) and Sculptra®, is hosting in-person, interactive activations at PrideFest on Sunday, June 26th.
"We are honored to be a part of NYC Pride this year," said Carrie Caulkins, Vice President, U.S. Aesthetics Marketing at Galderma. "There is power in defining your appearance on your own terms. Consumers, including those in the LGBTQIA+ patient population, are turning to aesthetics now more than ever to honor their identity. The best part about the Galderma Aesthetics portfolio is that you can express yourself naturally – every smile, laugh, frown, and expression in between is authentically you."
This month marks the official launch of Restylane's "XpresYourself" communications campaign, which gives a nod to Restylane's XpresHAn Technology™, a unique manufacturing process in four Restylane products* which allows them to maintain natural movement and expressions for natural-looking results.1-3 The campaign complements the NYC Pride 2022 theme, "Unapologetically Us," which celebrates the community's resilience and determination to live out their truth with no apologies.
Galderma will be onsite providing information about Restylane, Dysport and Sculptra with special live performances throughout the day, a chance to win prizes, personalized consultations with top NYC aesthetic injectors and the opportunity to receive up to $200 off Galderma Aesthetics treatments through a special Galderma ASPIRE Rewards offer. In addition to in-person activations, Galderma will also kick off its dedicated XpresYourself influencer program with ongoing talent collaborations through the end of the year.
"Each day we strive to advance dermatology for every skin story," Caulkins said. "Galderma is excited for the opportunity to express its ongoing commitment to the LGBTQIA+ community and looks forward to celebrating Pride this month and beyond."
For those unable to join Galderma at NYC PrideFest, check out RestylaneUSA, DysportUSA and SculptraUSA on Instagram to follow all of the onsite action.
To learn more about Galderma's portfolio, visit .
*Products formulated with XpresHAn Technology™ include Restylane® Contour, Restylane® Kysse, Restylane® Defyne and Restylane® Refyne.
Indication: 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.
Please read full Important Safety Information, including Distant Spread of Toxin Effect Boxed Warning, at the bottom of the page.
About Galderma
Galderma is the world's largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we're in shapes our life stories, we are advancing dermatology for every skin story. For more information: .
About Galderma's RESTYLANE® Product Portfolio
With over 50 million treatments worldwide4 and counting, the Restylane® family of HA dermal fillers is a diverse and broad portfolio of dermal fillers in the U.S. These products help smooth facial wrinkles and folds, such as smile lines (Restylane® L, Restylane® Refyne, Restylane® Defyne and Restylane® Lyft with Lidocaine), augment and correct mild to moderate chin retrusion (Restylane® Defyne), create fuller and more accentuated lips (Restylane® Silk, Restylane®-L and Restylane® Kysse), add lift and volume to the cheeks and back of the hands (Restylane® Lyft with Lidocaine), and augment cheeks and correct midface contour deficiencies (Restylane® Contour). To learn more about the Restylane® family of HA dermal fillers, visit .
About Galderma's collaboration with Ipsen
Dysport® (abobotulinumtoxinA) 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. Dysport is also marketed as AZZALURE® in the EU for the treatment of glabellar lines with more than 40 million treatments in the EU and U.S. combined and with approvals in 74 countries. To learn more about Dysport products, visit .
Dysport is manufactured by Ipsen, a global specialty-driven pharmaceutical company. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen's botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, the European Union, Australia, South Korea, Canada, Brazil, Argentina and certain other countries. Ipsen continues to promote Dysport within certain therapeutic indications in countries around the world. For more information on Ipsen, visit .
About SCULPTRA®
Sculptra
® works to help stimulate the skin's own collagen production and is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.5,6
Sculptra is an injectable biostimulator containing microparticles of poly-l-lactic acid (PLLA) which helps gradually revitalize the skin's structural foundation, providing natural-looking, long-term results for up to 2 years†.5,7-8 Sculptra was first approved for aesthetic use in 2009 in the United States and is currently available in more than 40 countries globally. To learn more about Sculptra products, visit
† Clinical study ended at 96 weeks (2 years)
To earn exclusive rewards, bonuses and discounts on Galderma's aesthetic treatments, join the ASPIRE Galderma Rewards program. To learn more, visit .
Investor and media relations
Christian Marcoux, M.Sc.
Chief Communications Officer
[email protected]
+41 21 642 71 99
Media
Shannon Iwaniuk
Director of Communications
[email protected]
DYSPORT IMPORTANT SAFETY INFORMATION
Dysport® (abobotulinumtoxinA) 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.
Important Safety Information
What is the most important information you should know about Dysport? Spread of Toxin Effects: In some cases, the effects of Dysport and all botulinum toxin products may affect areas of the body away from the injection site. Symptoms can happen hours to weeks after injection and may include swallowing and breathing problems, loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, or loss of bladder control. Swallowing and breathing problems can be life threatening and there have been reports of death. You are at the highest risk if these problems are pre
‐
existing before injection.
These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.
Do not have Dysport treatment if you: are allergic to Dysport or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow's milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®, have a skin infection at the planned injection site, under 18 years of age, or are pregnant or breastfeeding.
The dose of Dysport is not the same as the dose of any other botulinum toxin product and cannot be compared to the dose of any other product you may have used.
Tell your doctor about any swallowing or breathing difficulties and all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis, or Lambert‐Eaton syndrome, which may increase the risk of serious side effects including difficulty swallowing and difficulty breathing. Serious allergic reactions have occurred with the use of Dysport. Dry eye has also been reported.
Tell your doctor about all of your medical conditions, including if you have surgical changes to your face, very weak muscles in the treatment area, any abnormal facial change, injection site inflammation, droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, wrinkles that can't be smoothed by spreading them apart, or if you are pregnant or breastfeeding or planning to become pregnant or breastfeed.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects.
Do not start any new medicines while taking Dysport without talking to your doctor first.
Especially tell your doctor if you: have received any other botulinum toxin product, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA), in the last four months or any in the past (be sure your doctor knows exactly which product you received, have recently received an antibiotic by injection, take muscle relaxants, take an allergy or cold medicine, or take a sleep medicine.
Common Side Effects
The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea.
Ask your doctor if Dysport is right for you.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
Please see Dysport Full Prescribing Information including Medication Guide at DysportUSA.com.
RESTYLANE IMPORTANT SAFETY INFORMATION
The Restylane family of products are indicated for patients over the age of 21, and includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Kysse, Restylane® Refyne, Restylane® Defyne, and Restylane® Contour.
APPROVED USES
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.
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. Restylane® Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss.
Restylane® Silk is for lip augmentation and for correction of perioral wrinkles.
Restylane® Kysse is for lip augmentation and for correction of upper perioral wrinkles.
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.
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. Restylane® Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.
Restylane® Contour is for cheek augmentation and for the correction of midface contour deficiencies.
Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), are allergic to lidocaine or gram-positive bacterial proteins used to make hyaluronic acid, prone to bleeding, or have a bleeding disorder. The safety of use while pregnant or breastfeeding has not been studied. Tell your doctor if you have a history of scarring or pigmentation disorders as these side effects can occur with hyaluronic acid fillers. Tell your doctor if you are planning other cosmetic treatments (i.e., lasers and chemical peels) as there is a possible risk of inflammation at the injection site.
Tell your doctor if you're taking medications that lower your body's immune response or affect bleeding, such as aspirin or warfarin, as these medications may increase the risk of bruising or bleeding at the gel injection site. Using these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete.
The most common side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. The risk of unintentional injection into a blood vessel is small but can occur and could result in serious complications, which may be permanent including, 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 Restylane® product, please call Galderma Laboratories, L.P. at 1-855-425-8722.
To learn more about serious but rare side effects and full Important Safety Information, visit .
SCULPTRA
IMPORTANT SAFETY INFORMATION
Indication: Sculptra® (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.
Sculptra 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 has unique injection requirements and should only be used by a trained healthcare practitioner. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.
Sculptra 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 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 is available only through a licensed practitioner. Complete Instructions for Use are available at .
References:
Philipp-Dormston WG, Schuster B, PoddaM. Perceived naturalness of facial expression after hyaluronic acid filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19:1600-16064.
Öhrlund Å. Evaluation of rheometry amplitude sweep cross-over point as an index of flexibility for HA fillers. JCDSA.2018;8:47-54.
Data on file. MA-34483 Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2021.
Data on file. MA-39680. Fort Worth, TX: Galderma Laboratories, L.P., 2019.
Sculptra. Instructions for Use. Galderma Laboratories, L.P., 2021.
Goldberg D, Guana A, Volk A, Daro-Kaftan E. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39(6):915-922.
Stein P, Vitavska O, Kind P, Hoppe W, Wieczorek H, Schürer NY. The biological basis for poly-L-lactic acid-induced augmentation. J Dermatol Sci. 2015;78:26-33.
Data on file. 43USSA1705ext clinical study report. Fort Worth, TX: Galderma Laboratories, L.P. 2021.
SOURCE Galderma
Collaborate
Analysis
Perform a panoramic analysis of this field.
login
or
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free