The document summarizes key information about Juvederm XC, a hyaluronic acid dermal filler. It has three main points:
1) Juvederm XC contains lidocaine, which clinical studies show provides a more comfortable patient experience compared to Juvederm without lidocaine. Over 90% of patients reported less pain with Juvederm XC.
2) The addition of lidocaine does not impact the chemical or physical properties of Juvederm. Clinical trials found Juvederm XC to be as effective and safe as Juvederm without lidocaine, with the exception of less pain and tenderness.
3
Dermal fillers are an excellent choice for minimizing wrinkles and restoring youthful fullness to the face. However, with all the different options available, choosing the right dermal filler can be overwhelming. To help you find the right dermal filler for you Images Med Spa has created a guide to help you through your decision.
Cheek Fillers|Facial Aesthetic| Facial Aesthetic by Dr Rajat Sachdeva| Facial...Dr. Rajat Sachdeva
Cheek Fillers rejuvenate the cheeks and to regain last volume.
Autologous Fat Injection, where your own fat harvested from some other area can be used to restore volume of cheeks.
Some other fillers like Hyaluronic acid, Ca Hydroxide and Polymethyl Metacrylate are injected with fine needles in the target area eliminate wrinkles and enhances cheeks volume.
Micro Needling is a minimally invasive procedure that has little downtime, is safe on all skin types and will leave skin looking smoother and younger.
Micro Needling stimulates the bodies natural healing and will rejuvenate the skin and can reduce:
Lines & Wrinkles
Sun Damage
Skin Laxity
Acne Scars
Stretch Marks
Hair Loss and more
www.MDNeedlePen.com
Dermal fillers are an excellent choice for minimizing wrinkles and restoring youthful fullness to the face. However, with all the different options available, choosing the right dermal filler can be overwhelming. To help you find the right dermal filler for you Images Med Spa has created a guide to help you through your decision.
Cheek Fillers|Facial Aesthetic| Facial Aesthetic by Dr Rajat Sachdeva| Facial...Dr. Rajat Sachdeva
Cheek Fillers rejuvenate the cheeks and to regain last volume.
Autologous Fat Injection, where your own fat harvested from some other area can be used to restore volume of cheeks.
Some other fillers like Hyaluronic acid, Ca Hydroxide and Polymethyl Metacrylate are injected with fine needles in the target area eliminate wrinkles and enhances cheeks volume.
Micro Needling is a minimally invasive procedure that has little downtime, is safe on all skin types and will leave skin looking smoother and younger.
Micro Needling stimulates the bodies natural healing and will rejuvenate the skin and can reduce:
Lines & Wrinkles
Sun Damage
Skin Laxity
Acne Scars
Stretch Marks
Hair Loss and more
www.MDNeedlePen.com
The Art of Liquid Face Lift (Dermal Fillers)Osama Moawad
Soft tissue fillers are flexible substances that can be injected into the skin to improve the appearance of fine lines and wrinkles, plump lips, fill hollow cheeks, repair various facial imperfections, improve scars, and elevate deep folds. Perhaps nothing is more gratifying for cosmetic patients than having an immediate correction of rhytides or scars as a result of the injection of a dermal filler The result is a smoother, more youthful appearance with minimal "downtime" and maximum safety. Prof. Moawad uses a variety of soft tissue fillers, including, hyaluronic acid, and autologous fat (one's own fat) among others. Since filler substances do not involve major surgery and are generally cost-effective, men and women are using these youth-enhancing techniques more than ever. With the increasing desire for people to achieve a more youthful appearance, the aging baby boomer population, and the increased demand for "lunch-time procedures," the pharmaceutical market has responded by providing the cosmetic surgeon with an increasing number of options to meet the demands of the cosmetic patient.
If you want plumper and fuller lip,lip fillers are for you.They are bio compatible injectable collagen which are injected in your lips to give it a more fuller and enhanced look.They are basically hyaluronic acid which has volumizing effect.Your lips might look swollen for a week after the treatment but these symptoms subside eventually.Juvederm and Restylane are the commonly used lip fillers that are approved by FDA.You will likely need some follow up sessions after 6 months or even a year.The whole treatment takes upto an hour and effect usually shows after 15 days.
Dr Sachdeva's Dental clinic and Facial aesthetic centre is one of the leading clinics performing lip fillers and lip augmentation procedures in Delhi. So hurry up and come book an appointment with us at Dr.Sachdeva’s Dental Institute, Ashok Vihar, Delhi which has state of the art clinic and all the latest and advanced equipments.
To book an appointment contact:
Dr. Rajat Sachdeva
Director & Mentor
Dr Sachdeva’s Dental Aesthetic And Implant Institute
I 101, Ashok Vihar Phase 1, Delhi- 110052
Contact us at
Phone : +919818894041,01142464041
Our Websites:
www.sachdevadentalcare.com
www.dentalimplantindia.co.in
www.dentalclinicindelhi.com
www.dentalcoursesdelhi.com
Facebook- dentalcoursesdelhi
Youtube- drrajatsachdeva
Linkedin- drrajatsachdeva
Slideshare- Dr Rajat Sachdeva
Twitter Page- drrajatsachdeva
Instagram page- surgicalmasterrajat
THE ART OF NON SURGICAL SKIN REJUVENATION. MULTIPLE APPROACHESOsama Moawad
The sudden explosion in recent years of nonsurgical
rejuvenative techniques is patient-driven. The modern
patient, man or woman, desires quick, safe and pre-
dictable nonsurgical techniques that will confer some
form of facial rejuvenation and at the same time allow
them to get back to work or their social lives with a
minimum of downtime. By that is meant a modicum
of bruising and swelling for 2–3 days (i.e., over a week-
end) and not the 2–4 weeks of downtime and scars
that often accompany open surgical techniques.
Whilst nonsurgical techniques are not a substitute
for traditional rejuvenative surgery, the combination
of several nonsurgical tools and procedures has be-
come a powerful adjunct to or a temporizing substi-
tute for open surgery.
Face Design with Aesthefill(Poly Lactic Acid)Yong Hyun KWON
Aesthefill is made of PLA which stimulates collagen synthesis.
This presentation is about characteristics of Aesthefill and how to use it for Aesthetic Medicine.
You can watch procedure video on YouTube
(https://youtu.be/4MT5a6BWhxE)
Mesotherapy treatment is frequently used to solve many problems regarding health issues. In this treatment injections are adminstrated into the supposed part of the body.
http://www.informationonmesotherapy.com
MIcro Lift Threads : Latest Revelation in Face and Body Lift http://spectroni...Spectronix Group
Micro Thread Lift (Reandne) is the most Novel Thread Procedure having lots of advantages over Previous Threads based Procedure.
The procedure is performed under Local Anesthetic Cream and has the following advantages for Face Contouring, Neck Lift, Wrinkle Treatment, Breast firming and lifting, Hip up, Saddle Bags and abdomen lift.
The procedure is SAFE, Non Surgical, Shorter Procedure Time, Use of only topical Anesthesia, No downtime, Immediate Effect (3-4 days after procedure). http://spectronixglobal.com/
Mesotherapy is the procedure to injection of plant, extracts, vitamins, enzymes, hormones, and rejuvenate the skin.
Series of injection allegedly target fat cell to induce lypolysis..
This rejuvenate and nourish skin, stimulates production of collagen and elastin.
Call us regarding Facial aesthetic Treatment:-
Dr. Rajat Sachdeva
+919818894041,01142464041
drrajatsachdeva@gmail.com
Follow us here:-
• Google+ link: https://goo.gl/vqAmvr
• Facebook link: https://goo.gl/tui98A
• Youtube link: https://goo.gl/mk7jfm
• Linkedin link: https://goo.gl/PrPgpB
• Slideshare link : http://goo.gl/0HY6ep
• Twitter Page : https://goo.gl/tohkcI
• Instagram page : https://goo.gl/OOGVig
Learn more:-
• www.sachdevadentalcare.com
• www.dentalclinicindelhi.com
• www.dentalimplantindia.co.in
• www.dentalcoursesdelhi.com
• www.facialaestheticsdelhi.com
This presentation explains the various correction and caveats related to using dermal fillers. The intended audience is medical professionals. Dr. Scheiner is a Plastic Surgeon and the President of ASAMP (The American Society of Aesthetic Medical Professionals). ASAMP certifies medical professionals for cosmetic injection procedures (Botox; Dermal Fillers) and is accredited through the American Academy of Family Physicians (up to 14 CME credits).
Training for periorbital and upper face treatment with botox and JuvedermDokter Frodo Gaymans
Training for periorbital and upper face treatment with botox and Juvederm
Training for experienced injectors.
no rights may be derived from this training
The Art of Liquid Face Lift (Dermal Fillers)Osama Moawad
Soft tissue fillers are flexible substances that can be injected into the skin to improve the appearance of fine lines and wrinkles, plump lips, fill hollow cheeks, repair various facial imperfections, improve scars, and elevate deep folds. Perhaps nothing is more gratifying for cosmetic patients than having an immediate correction of rhytides or scars as a result of the injection of a dermal filler The result is a smoother, more youthful appearance with minimal "downtime" and maximum safety. Prof. Moawad uses a variety of soft tissue fillers, including, hyaluronic acid, and autologous fat (one's own fat) among others. Since filler substances do not involve major surgery and are generally cost-effective, men and women are using these youth-enhancing techniques more than ever. With the increasing desire for people to achieve a more youthful appearance, the aging baby boomer population, and the increased demand for "lunch-time procedures," the pharmaceutical market has responded by providing the cosmetic surgeon with an increasing number of options to meet the demands of the cosmetic patient.
If you want plumper and fuller lip,lip fillers are for you.They are bio compatible injectable collagen which are injected in your lips to give it a more fuller and enhanced look.They are basically hyaluronic acid which has volumizing effect.Your lips might look swollen for a week after the treatment but these symptoms subside eventually.Juvederm and Restylane are the commonly used lip fillers that are approved by FDA.You will likely need some follow up sessions after 6 months or even a year.The whole treatment takes upto an hour and effect usually shows after 15 days.
Dr Sachdeva's Dental clinic and Facial aesthetic centre is one of the leading clinics performing lip fillers and lip augmentation procedures in Delhi. So hurry up and come book an appointment with us at Dr.Sachdeva’s Dental Institute, Ashok Vihar, Delhi which has state of the art clinic and all the latest and advanced equipments.
To book an appointment contact:
Dr. Rajat Sachdeva
Director & Mentor
Dr Sachdeva’s Dental Aesthetic And Implant Institute
I 101, Ashok Vihar Phase 1, Delhi- 110052
Contact us at
Phone : +919818894041,01142464041
Our Websites:
www.sachdevadentalcare.com
www.dentalimplantindia.co.in
www.dentalclinicindelhi.com
www.dentalcoursesdelhi.com
Facebook- dentalcoursesdelhi
Youtube- drrajatsachdeva
Linkedin- drrajatsachdeva
Slideshare- Dr Rajat Sachdeva
Twitter Page- drrajatsachdeva
Instagram page- surgicalmasterrajat
THE ART OF NON SURGICAL SKIN REJUVENATION. MULTIPLE APPROACHESOsama Moawad
The sudden explosion in recent years of nonsurgical
rejuvenative techniques is patient-driven. The modern
patient, man or woman, desires quick, safe and pre-
dictable nonsurgical techniques that will confer some
form of facial rejuvenation and at the same time allow
them to get back to work or their social lives with a
minimum of downtime. By that is meant a modicum
of bruising and swelling for 2–3 days (i.e., over a week-
end) and not the 2–4 weeks of downtime and scars
that often accompany open surgical techniques.
Whilst nonsurgical techniques are not a substitute
for traditional rejuvenative surgery, the combination
of several nonsurgical tools and procedures has be-
come a powerful adjunct to or a temporizing substi-
tute for open surgery.
Face Design with Aesthefill(Poly Lactic Acid)Yong Hyun KWON
Aesthefill is made of PLA which stimulates collagen synthesis.
This presentation is about characteristics of Aesthefill and how to use it for Aesthetic Medicine.
You can watch procedure video on YouTube
(https://youtu.be/4MT5a6BWhxE)
Mesotherapy treatment is frequently used to solve many problems regarding health issues. In this treatment injections are adminstrated into the supposed part of the body.
http://www.informationonmesotherapy.com
MIcro Lift Threads : Latest Revelation in Face and Body Lift http://spectroni...Spectronix Group
Micro Thread Lift (Reandne) is the most Novel Thread Procedure having lots of advantages over Previous Threads based Procedure.
The procedure is performed under Local Anesthetic Cream and has the following advantages for Face Contouring, Neck Lift, Wrinkle Treatment, Breast firming and lifting, Hip up, Saddle Bags and abdomen lift.
The procedure is SAFE, Non Surgical, Shorter Procedure Time, Use of only topical Anesthesia, No downtime, Immediate Effect (3-4 days after procedure). http://spectronixglobal.com/
Mesotherapy is the procedure to injection of plant, extracts, vitamins, enzymes, hormones, and rejuvenate the skin.
Series of injection allegedly target fat cell to induce lypolysis..
This rejuvenate and nourish skin, stimulates production of collagen and elastin.
Call us regarding Facial aesthetic Treatment:-
Dr. Rajat Sachdeva
+919818894041,01142464041
drrajatsachdeva@gmail.com
Follow us here:-
• Google+ link: https://goo.gl/vqAmvr
• Facebook link: https://goo.gl/tui98A
• Youtube link: https://goo.gl/mk7jfm
• Linkedin link: https://goo.gl/PrPgpB
• Slideshare link : http://goo.gl/0HY6ep
• Twitter Page : https://goo.gl/tohkcI
• Instagram page : https://goo.gl/OOGVig
Learn more:-
• www.sachdevadentalcare.com
• www.dentalclinicindelhi.com
• www.dentalimplantindia.co.in
• www.dentalcoursesdelhi.com
• www.facialaestheticsdelhi.com
This presentation explains the various correction and caveats related to using dermal fillers. The intended audience is medical professionals. Dr. Scheiner is a Plastic Surgeon and the President of ASAMP (The American Society of Aesthetic Medical Professionals). ASAMP certifies medical professionals for cosmetic injection procedures (Botox; Dermal Fillers) and is accredited through the American Academy of Family Physicians (up to 14 CME credits).
Training for periorbital and upper face treatment with botox and JuvedermDokter Frodo Gaymans
Training for periorbital and upper face treatment with botox and Juvederm
Training for experienced injectors.
no rights may be derived from this training
Whether you are a doctor or a medical researcher, details regarding the face anatomy can help you explain your patients about the latest surgeries and medical actions that are taking place. Further, using excellent Face anatomy PowerPoint Templates can instantly easy your effort and make the overall explanation process instant. More information: http://www.medicalppttemplates.com/medical-ppt-templates.aspx/Face-Anatomy-173
Herstel schoonheid in het gezicht dmv injectables en optische illusieDokter Frodo Gaymans
Optische illusie is een belangrijk onderdeel van het balanseren van schoonheid in een gezicht.
Een mooi voorbeeld hiervan is de filler behandeling: liquid facelift of de V-lift.
In deze presentatie ga ik dieper in op het balanseren van het onderste gedeelte van het gezicht dmv een kinvergroting of de masseter reductie.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
2. 2
JUVÉDERM® XC Sets the Standard
The first and only smooth-consistency gel
formulated with lidocaine
Provides a more comfortable
patient experience1-3,*
The only HA filler FDA approved† to last up to
1 year with initial treatment1,2,‡
FDA = US Food and Drug Administration; HA = hyaluronic acid.
*When compared to the nonlidocaine JUVÉDERM® formulations.
†
In the United States, JUVÉDERM® injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial
wrinkles and folds (such as nasolabial folds).
‡
This includes all JUVÉDERM® injectable gel formulations.
1. JUVÉDERM® Ultra XC Directions for Use; 2. JUVÉDERM® Ultra Plus Directions for Use; 3. Weinkle et al. J Cosmet Dermatol. 2009.
3. 3
JUVÉDERM XC Possesses Unique Physical
®
and Chemical Properties¹
• HYLACROSS™ technology: robust and smooth consistency1
– Proprietary cross-linking and homogenization
– Uniform extrusion force and smooth flow
– Random sizes and shapes that result in a smooth-consistency gel
– Results in a unique 3D matrix that is strong and robust, yet
still soft and smooth
JUVÉDERM® Competitive HA fillers
More cross-linked Smooth consistency Less cross-linked Granular consistency
The significance of the difference has not been established in controlled clinical studies.
1. Data on file, Allergan, Inc.; JUVÉDERM® Technical File.
4. 4
Adding Lidocaine as a Dry Substance Ensures the Same
Chemical and Physical Characteristics as
JUVÉDERM® Injectable Gel Without Lidocaine
• Addition of lidocaine has no effect on1,2:
– HA concentration or volume – Product viscosity or extrusion force
– HA degradation – pH level
1. Weinkle et al. J Cosmet Dermatol. 2009; 2. Data on file, Allergan, Inc.
5. 5
Functional Equivalence Between JUVÉDERM ®
and JUVÉDERM® XC
• Lidocaine, when added as dry substance, does not increase the
volume of the gel, dilute the HA content, or interfere with HA
cross-linking1,2
• Lidocaine is rapidly released from the gel and metabolized after the
dermal filler is injected1,2
JUVÉDERM® Injectable Gel
Chemical/Physical Test
With and Without Lidocaine
Susceptibility to degradation
• Enzymatic Equivalent
• Free radical
Rheologic properties Equivalent
pH Equivalent
Extrusion force Equivalent
1. Weinkle et al. J Cosmet Dermatol. 2009; 2. Data on file, Allergan, Inc.
6. 6
Summary of JUVÉDERM Physical ®
and Chemical Properties¹
JUVÉDERM ®
JUVÉDERM ® JUVÉDERM ® JUVÉDERM ®
Ultra
Ultra Ultra XC Ultra Plus
Plus XC
Lidocaine concentration NA 0.3% NA 0.3%
Total HA concentration 24 mg/mL 24 mg/mL 24 mg/mL 24 mg/mL
Percentage
~10% ~10% ~10% ~10%
uncross-linked HAa
Degree of cross-linking ~6% ~6% ~8% ~8%
Smooth Smooth Smooth Smooth
Formulation
cohesive gel cohesive gel cohesive gel cohesive gel
Needle 30 G 30 G 27 G 27 G
a
Uncrosslinked HA is defined as the portion of the product including lightly cross-linked chains and fragments that will aid extrusion/flow.
1. Data on file. Allergan, Inc; JUVÉDERM® Technical File.
7. 7
JUVÉDERM XC Pivotal Study: ®
Comparison of Effectiveness and Safety
With JUVÉDERM®¹
Multicenter, double-blind, randomized, within subject comparison
• 72 subjects total (18 subjects at each center)
• 4 study centers
Randomization
• JUVÉDERM® XC in 1 NLF
• JUVÉDERM® (without lidocaine) in the opposite NLF
Protocol
• Use of dental block was not permitted in the study
• Investigators determined appropriate formulation (JUVÉDERM® Ultra or
JUVÉDERM® Ultra Plus) and filler volume up to a maximum total volume
of 2 syringes (1.6 mL) per NLF
NLF = nasolabial fold.
1. Weinkle et al. J Cosmet Dermatol. 2009.
8. 8
JUVÉDERM XC Study Flow ®
and Assessments¹
Day 2 Day 14
Day 0 (Phone/e-mail) (Office visit)
JUVÉDERM®
treatment
Investigator Baseline Investigator Assessment: Investigator Day 14
Assessment: Common treatment-site Assessment:
NLF Severity Scale (NLFSS) responses (CTRs) NLF Severity Scale (NLFSS)
Treatment:
Investigator Assessment:
Randomization,
CTRs
injection volume, technique
Subject Assessment: Subject Assessment:
Procedural pain score NLF Severity Scale (NLFSS)
Comparative procedural pain score
NLF Severity Scale (NLFSS)
Subject Diary for CTRs
1. Weinkle et al. J Cosmet Dermatol. 2009.
9. 9
JUVÉDERM XC Subject and Investigator
®
Effectiveness Assessments¹
Primary: Procedural Pain
Subjects rated pain during injection;
0–10 scale within 30 minutes after both sides were treated
0 10
1 2 3 4 5 6 7 8 9 Worst
No pain pain imaginable
Secondary: Comparative Procedural Pain Scale (CPPS)
Subjects compared procedural pain between the right and left NLF;
5-point scale immediately and within 30 minutes after both sides were treated
-2 -1 0 1 2
Right slightly more Left slightly more
Right more painful painful No difference painful Left more painful
Secondary: NLF Severity Scale (NLFSS)
Investigators and subjects rated NLF severity;
5-point scale at pretreatment and day 14
0 1 2 3 4
None Mild Moderate Severe Extreme
1.Weinkle et al. J Cosmet Dermatol. 2009.
10. 10
JUVÉDERM XC Subject and Investigator
®
Safety Assessments¹
• Subjects maintained diary records using a validated
interactive voice response system (IVRS) for 2 weeks to
track CTRs
• Subjects reported absence or presence, severity, and
location (right or left NLF) of the most common CTRs
• Subjects also reported and investigators solicited
additional CTRs
CTR = common treatment-site response
1.Weinkle et al. J Cosmet Dermatol. 2009; 2. Data on file, Allergan, Inc.
11. 11
JUVÉDERM XC Provides a More ®
Comfortable Patient Experience 1-3
More Than 90% of the Subjects JUVÉDERM® XC Provides Significant
Reported Less Treatment Pain Reduction in Pain Compared With
With JUVÉDERM® XC1-3,* JUVÉDERM® Without Lidocaine1-3,*
(N = 72)
Less painful
63%
64% reduction
29%
Slightly
less painful
4%
With Lidocaine Without Lidocaine
More painful 3%
Slightly more painful P < .001 (N=72)
*When compared to the nonlidocaine JUVÉDERM® formulations.
†
For the primary measure, the absolute mean difference in pain score (3.4) exceeds the minimum clinically significant difference of 1.4 established a priori,
which demonstrates a clinically meaningful difference in pain for JUVÉDERM® with lidocaine
1. JUVÉDERM® Ultra XC Directions for Use; 2. JUVÉDERM® Ultra Plus Directions for Use; 3. Weinkle et al. J Cosmet Dermatol. 2009.
12. 12
With the Exception of Pain and Tenderness,
CTRs Were Similar for All JUVÉDERM®
Formulations 1-3
• Most CTRs were mild to moderate in severity and were
consistent with those typical of HA fillers
– Pain and tenderness were significantly reduced for
JUVÉDERM® XC
– No subject reported severe pain for JUVÉDERM® XC
• There were no adverse events other than CTRs related to
treatment
• The potential for allergic reactions to lidocaine is reduced
due to the use of preservative-free powder4
1.JUVÉDERM® Ultra XC Directions for Use; 2. JUVÉDERM® Ultra Plus Directions for Use; 3. Weinkle et al. J Cosmet Dermatol. 2009;
4. Jackson et al. J Am Dent Assoc. 1994 .
13. 13
Summary of JUVÉDERM XC ®
Registration Trial
Effectiveness
• 9 out of 10 patients reported less pain with JUVÉDERM® XC1,*
• Patient assessment of procedural pain with JUVÉDERM® XC averaged 2.0
(compared with an average of 5.4 without lidocaine) on an 11-point scale (0 = no pain
and 10 = worst pain imaginable)1
• NLF severity was significantly improved with both JUVÉDERM® XC and nonlidocaine
JUVÉDERM®
Safety
• With the exception of less pain and tenderness with JUVÉDERM® XC, CTRs were
similar for all JUVÉDERM® formulations1
• There were no adverse events other than CTRs related to treatment1
*When compared to the nonlidocaine formulations.
1. Weinkle SM et al. J Cosmet Dermatol. 2009.
14. 14
Pivotal Study: Design 1,2
• Multicenter, double-blind, randomized,
within-subject study
• Assess the effectiveness and safety of JUVÉDERM®*
compared with ZYPLAST® in the correction of moderate
to severe NLFs
– JUVÉDERM® Ultra (24 HV), n = 146
– JUVÉDERM® Ultra Plus (30 HV), n = 146
• Each site had
– Treating investigator (not masked)
– Independent expert reviewer (IER) (masked)
• All subjects masked
*Although 3 formulations of JUVÉDERM® were evaluated in the pivotal study, only 2 are currently available in the United States.
1. Pinksy et al. Aesthetic Surg J. 2008; 2. Data on file, Allergan, Inc.
15. 15
Pivotal Study: Treatment
and Assessment 1,2
• Treatment
– Subjects randomly assigned to receive either JUVÉDERM® Ultra or
JUVÉDERM® Ultra Plus in 1 NLF
– All subjects received ZYPLAST® in opposite NLF
– Injections were provided to achieve optimal correction
(1 or 2 touch-ups allowed within the first 4 weeks if necessary)
– Subjects followed for up to 24 weeks after last treatment
– At the conclusion of the randomized trial, an open-label, extended
follow-up study included observations out to ~ 1.5 years after last treatment
• Assessment
– Effectiveness: NLF severity rated by IER and subject on the
5-point NLF Severity Scale (NLFSS) (ie, none, mild, moderate, severe,
or extreme)
– Safety/tolerability: Subjects recorded treatment-site reactions daily for
14 days after initial treatment and each touch-up
IER = Independent expert reviewer
1. Pinksy et al. Aesthetic Surg J. 2008; 2. Data on file, Allergan, Inc.
16. 16
JUVÉDERM Open-Label Extended ®
Follow-up Study: Methods
• After completing 24 weeks of follow-up during the pivotal trial, subjects could
return at their convenience for a complimentary repeat treatment with their
preferred product1
• Subjects were assessed by the treating investigator when they returned for
re-treatment (up to approximately 1.5 years after last treatment)2
• The number of subjects evaluated during the extended trial were1:
– 116 of the 146 (79%) subjects in the JUVÉDERM® Ultra
injectable gel cohort
– 111 of the 146 (76%) subjects in the JUVÉDERM® Ultra Plus
injectable gel cohort
• Subjects returning for the follow-up study were representative of the pivotal
trial subjects in terms of1:
– Baseline nasolabial fold (NLF) severity
– NLF severity at week 24
– Initial injection volume
1. Pinksy et al. Aesthetic Surg J. 2008; 2. Data on file, Allergan, Inc., Pinsky Final Report.
17. 17
Majority of JUVÉDERM Subjects Maintained a ®
Clinically Significant* Improvement
Longer Than 9 Months¹
JUVÉDERM® Ultra JUVÉDERM® Ultra Plus
Improvement in WAS, %
Subjects With ≥ 1-Point
*Improvement of ≥ 1 in wrinkle assessment score (WAS) as assessed by treating investigator is defined as clinically significant.
1. Pinksy et al. Aesthetic Surg J. 2008.
18. 18
JUVÉDERM Ultra Plus in Severe NLFs: ®
Physician Assessment¹
• Improvement of ≥ 1 point
achieved by
Subjects With Clinically Significant
– 96% of subjects at 24 weeks
– 81% of subjects at
Improvement, %
12 months or beyond
• Improvement of ≥ 2 points
achieved by
– 67% of subjects at 24 weeks
– 38% of subjects at
12 months or beyond
1. Adapted from Lupo et al. Plast Reconstr Surg. 2008.
20. 20
JUVÉDERM Is the Only HA Filler FDA ®
Approved to Last up to 1 Year*
With Initial Treatment¹ ,2,†
• JUVÉDERM® Ultra and JUVÉDERM® Ultra Plus offer long-lasting clinical
improvement for up to 1 year in NLFs
– Majority of subjects maintained a clinically significant improvement
(≥ 1 point) over an extended period of time1,2
• JUVÉDERM® Ultra: 75% (> 9 months)
• JUVÉDERM® Ultra Plus: 78% (> 12 months)
• JUVÉDERM® Ultra Plus for severe NLFs: 81% (≥ 12 months)
• Repeat treatment required less than half of the original injection volume
• No treatment-related adverse events other than at the injection site
*In the United States, JUVÉDERM® injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles
and folds (such as nasolabial folds).
†
This includes all JUVEDERM injectable gel formulations.
1. Pinksy et al. Aesthetic Surg J. 2008; 2. Lupo et al. Plast Reconstr Surg. 2008.
21. 21
HA Resistance to Ovine Testicular
Hyaluronidase (OTH) Methods¹
• Study purpose
– To determine a dose-response relationship between
commercially available OTH and degradation of various
HA-based dermal filler products
• Dose response
– Test products incubated for 30 minutes with OTH concentrations
of 0, 5, 10, 20, and 40 U
• Time response (fixed 20-U enzyme concentration)
– JUVÉDERM®: 30, 60, 120 minutes; 24 hours
• Outcome measure
– Amount of soluble HA and molecular weight as determined by
SEC-MALS detector
– An increase in total soluble HA indicates degradation of the
HA network
SEC-MALS = size-exclusion chromatography coupled with a multiangle light scattering; soluble HA = uncross-linked HA or lightly cross-linked
HA chains or fragments that are in soluble form.
1. Jones et al. Dermatol Surg. In press.
22. 22
JUVÉDERM® Has Greater Resistance to Degradation Than
Restylane®, Yet Is Still Mostly
,*,†
Dissolved by OTH Within 24 Hours¹
Units of Ovine Testicular Hyaluronidase (OTH)
After 30-Minute Incubation
% Free HA
JUVÉDERM® Restylane®
Free HA = uncross-linked HA and lightly cross-linked chains or fragments that are in soluble form.
*In vitro.
†
Based on JUVÉDERM® Ultra Plus.
1. Jones et al. Dermatol Surg. In press.
23. 23
Practical Uses for JUVÉDERM® XC
JUVÉDERM® JUVÉDERM®
Ultra XC Ultra Plus XC
*In the United States, JUVÉDERM® injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to
n
severe facial wrinkles and folds (such as nasolabial folds).
24. 24
JUVÉDERM® Product Availability
Product description Syringe size
JUVÉDERM® Ultra XC 0.8 cc
JUVÉDERM® Ultra Plus XC 0.8 cc
JUVÉDERM® Ultra 0.8 cc
JUVÉDERM® Ultra Plus 0.8 cc
JUVÉDERM® Ultra Plus 0.4 cc
JUVÉDERM® Ultra 0.4 cc
25. 25
JUVÉDERM® XC Sets the Standard
The first and only smooth-consistency gel
formulated with lidocaine
Provides a more comfortable
patient experience1-3,*
The only HA filler FDA approved† to last up to
1 year with initial treatment1,2,‡
FDA = US Food and Drug Administration; HA = hyaluronic acid.
*When compared to the nonlidocaine JUVÉDERM® formulations.
†
In the United States, JUVÉDERM® injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial
wrinkles and folds (such as nasolabial folds).
‡
This includes all JUVÉDERM® injectable gel formulations.
1. JUVÉDERM® Ultra XC Directions for Use; 2. JUVÉDERM® Ultra Plus Directions for Use; 3. Weinkle et al. J Cosmet Dermatol. 2009.
26. 26
A Brief Description of Indications for Use,
Contraindications, Warnings, Precautions, and Adverse
Events for JUVÉDERM® Injectable Gel
Indication: In the United States, JUVÉDERM® injectable gel (including
JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and
JUVÉDERM® Ultra Plus XC) is indicated for injection into the mid-to-deep
dermis for correction of moderate to severe facial wrinkles and folds (such as
nasolabial folds).
Contraindications: JUVÉDERM® injectable gel should not be used in patients
who have severe allergies marked by a history of anaphylaxis or history or
presence of multiple severe allergies. JUVÉDERM® should not be used in
patients with a history of allergies to Gram-positive bacterial proteins.
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra XC should not be used in
patients with a history of allergies to lidocaine.
Warnings: JUVÉDERM® injectable gel should not be injected into blood
vessels. If there is an active inflammatory process or infection at specific
injection sites, treatment should be deferred until the underlying process
is controlled.
27. 27
A Brief Description of Indications for Use,
Contraindications, Warnings, Precautions, and Adverse Events
for JUVÉDERM® Injectable Gel (continued)
Precautions: The safety of JUVÉDERM® for use during pregnancy, in
breastfeeding females, or in patients under 18 years has not been established.
The safety and effectiveness of JUVÉDERM® injectable gel for the treatment of
areas other than facial wrinkles and folds (such as lips) have not been
established in controlled clinical studies. Patients who are using substances that
can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may
experience increased bruising or bleeding at injection site. Patients should inform
their physician before treatment if they are using these types of substances. As
with all skin-injection procedures, there is a risk of infection. JUVÉDERM® should
be used with caution in patients on immunosuppressive therapy, or therapy used
to decrease the body’s immune response, as there may be an increased risk of
infection. The safety of JUVÉDERM® in patients with a history of excessive
scarring (eg, hypertrophic scarring and keloid formations) and pigmentation
disorders has not been studied. If laser treatment, chemical peel, or any other
procedure based on active dermal response is considered after treatment with
JUVÉDERM® injectable gel, or if JUVÉDERM® is administered before the skin has
healed completely after such a procedure, there is a possible risk of an
inflammatory reaction at the treatment site.
28. 28
A Brief Description of Indications for Use,
Contraindications, Warnings, Precautions, and Adverse
Events for JUVÉDERM® Injectable Gel (continued)
Adverse events: The most commonly reported side effects are temporary
injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, and
bruising. Most side effects are mild or moderate in nature, and their duration is
short lasting (7 days).
Important: For full safety information, please visit www.juvederm.com or call
Allergan Product Support at 1-877-345-5372.
CAUTION: Rx only.
For directions for use (DFU), please visit www.juvederm.com/dfu.
This presentation will cover an overview of the JUVÉDERM ® Family of Hyaluronic Acid Fillers We’ll review the unique manufacturing process including the impact of the new lidocaine formulation Then we’ll review the registration trial for the lidocaine product, JUVÉDERM ® XC, and briefly cover the pivotal extension trial that earned JUVÉDERM ® injectable gel the US Food and Drug Administration (FDA) approval for 1-year duration on the approved labeling, and following that we’ll review the severe folds study Finally, we’ll discuss which formulation is best to use in which areas of the face
JUVÉDERM ® XC sets the standard for hyaluronic acid (HA) fillers. Product characteristics include: Smooth flow—smooth-consistency gel with even and consistent extrusion force formulated with lidocaine Smooth comfort—provides a more comfortable patient experience vs the nonlidocaine JUVÉDERM ® formulation 1-3* Smooth outcomes—the only HA filler FDA approved † to last up to 1 year with initial treatment 1,2, ‡
This section of the presentation will highlight the physical and chemical properties of JUVÉDERM ® that contribute to its performance when used as a dermal filler Allergan’s proprietary HYLACROSS ™ technology differs from other techniques for the preparation of HA gels, by using a high degree of cross-linking and homogenization to achieve a robust yet smooth-consistency gel with even flow characteristics This combination of characteristics alleviates the need to include large amounts of free HA in the formulation, and delivers a smooth-consistency gel that allows the application of uniform extrusion force throughout the procedure to achieve smooth outcomes Homogenization creates random HA sizes and shapes that permit more effective filling of voids when the gel is blended resulting in a smoother consistency. Homogenization also helps maintain the gel’s cross-linking during the formulation process, preserving its cohesive qualities Ultimately, a unique 3D matrix is created that is strong and robust, yet still soft and smooth This slide has representations of the cross-linking for JUVÉDERM ® and a competitor. JUVÉDERM ® is cross-linked to a greater extent, thereby decreasing the likelihood of degradation
The slide is a conceptual illustration for explanation purposes only on how lidocaine is added as a dry substance to JUVÉDERM ® Compared with the formulation of JUVÉDERM ® , the formulation of JUVÉDERM ® XC injectable gel differs only in the addition of dry lidocaine The product incorporates the same HA, cross-linker, and HYLACROSS™ technology as JUVÉDERM ® There is no dilution of the final product or additional volume due to the addition of lidocaine Since lidocaine does not interfere with the cross-linking process, the final product has the same degree of cross-linking and retains all the favorable characteristics of JUVÉDERM ® And, because the lidocaine is preservative-free, the likelihood of an allergic reaction is low
Comparisons of JUVÉDERM ® XC formulations to their nonlidocaine-containing counterparts reveal no changes in pH, rheologic properties, or extrusion force, thus establishing their functional equivalence
This slide summarizes the key properties of the JUVÉDERM ® Family of Hyaluronic Acid Fillers JUVÉDERM ® Ultra and JUVÉDERM ® Ultra Plus differ from each other in their chemical and physical properties for versatility in clinical use You can see that the lidocaine formulation of each product is identical to its counterpart except for the presence of lidocaine
We will now discuss the JUVÉDERM ® Family of Hyaluronic Acid Fillers and its clinical evidence. Its value in clinical practice will also be discussed The purpose of this pivotal trial was to demonstrate the reduction in procedural pain and evaluate the safety of JUVÉDERM ® XC compared with JUVÉDERM ® formulations that do not contain lidocaine In this split-face study, 72 subjects at 4 study centers received JUVÉDERM ® Ultra XC (n = 36) or JUVÉDERM ® Ultra Plus XC (n = 36) in 1 NLF, and JUVÉDERM ® Ultra or JUVÉDERM ® Ultra Plus without lidocaine in the opposite NLF No dental block was used; ice and/or EMLA ® were permitted The investigator selected the filler and volume that were appropriate for each subject Subjects were treated with up to 1.6 mL (or 2 syringes) per NLF
After informed consent, baseline NLF severity was assessed using the 5-point NLF Severity Scale (NLFSS) After both sides were treated, subjects reported their pain level, comparative procedural pain between the right and left NLF, and assessed NFL severity A telephone or e-mail follow-up visit was conducted by the investigator on the second day following treatment to assess common treatment-site responses (CTRs) Subjects entered CTRs through an interactive voice response system (IVRS). If there was no corresponding selection in the IVRS for a given treatment response, the subjects reported those occurrences directly to the investigator At the final study visit, the investigators assessed NLF severity
The primary measure was procedural pain that was graded on a 10-point categorical scale Secondary measures included a comparison of the right and left side treatment-related pain obtained immediately after both sides were treated NLF severity was measured prior to treatment using a 5-point scale (NLF Severity Scale [NLFSS]) and again at the final study visit. The improvement in NLF severity was calculated from these measures
Subjects accessed an IVRS system to record the absence, presence, severity, and location of treatment-site responses If a specific CTR was not available as a selection on the IVRS, subjects were instructed to report those occurrences directly to the investigator
For both formulations of JUVÉDERM ® XC, more than 90% of subjects reported less pain than on the side treated with JUVÉDERM ® without lidocaine For the primary measure, the absolute mean difference in pain score (3.4) exceeds the minimum clinically significant difference of 1.4 established a priori , which demonstrates a clinically meaningful difference in pain for JUVÉDERM ® with lidocaine Procedural pain scores were significantly lower for both JUVÉDERM ® Ultra XC and JUVÉDERM ® Ultra Plus XC Reduction in procedural pain scores between JUVEDERM ® with and without lidocaine was significant regardless of needle type, injection volume, use of topical anesthesia, and across investigators.
The treatment responses for all JUVÉDERM ® formulations were mild to moderate in severity, were typical of those observed with the use of HA fillers, and were mostly procedure-related Pain and tenderness were significantly reduced for JUVÉDERM ® XC formulations; no subject reported severe pain for JUVÉDERM ® XC Common treatment-site responses that extended beyond 14 days were classified as adverse events (AEs). There were few responses classified as AEs and there were no significant differences in AEs between formulations The incidence of AEs for JUVÉDERM ® XC and JUVÉDERM ® formulations were similar Most patients who have allergic reactions to lidocaine are sensitive to the preservatives rather than the lidocaine itself
The key top-line results to take from this trial are that: Treatment with JUVÉDERM ® XC formulations elicited fewer reports of pain than the corresponding nonlidocaine formulations in more than 90% of subjects Regardless of the treatment-related factors, physician- and subject-reported pain and tenderness were significantly lower for the lidocaine-based formulations of JUVÉDERM ® NLF severity was significantly improved with all JUVÉDERM ® injectable gel formulations There were few CTRs for any JUVÉDERM ® formulation Those that did occur were mild to moderate in severity and mostly procedure-related There were no significant differences in CTRs among the JUVÉDERM ® formulations other than pain
A large multicenter, double-blind, randomized pivotal trial included 3 formulations of JUVÉDERM ® ; only 2 are currently available in the United States. This study formed the basis for the June 2006 FDA approval of the JUVÉDERM ® Family of Hyaluronic Acid Fillers In the pivotal trial, JUVÉDERM ® dermal filler was compared with ZYPLAST ® bovine collagen in the treatment of NLFs. Collagens have been the standard comparators Each study site had 2 investigators who were considered experienced physician specialists in cosmetic dermatology or plastic surgery—one served as the treating investigator and performed the injections. The other, an independent expert reviewer (IER), served as a masked investigator and evaluated the effects of treatment. The subjects also were masked
All patients were randomized to receive JUVÉDERM ® Ultra or JUVÉDERM ® Ultra Plus formulations in 1 NLF. They received ZYPLAST ® in the other NLF Each NLF was treated to achieve full (100%) correction, without overcorrection. To make sure all treated subjects reached optimal correction, up to 2 touch-ups were allowed within 4 weeks after the initial treatment. The patients were then followed for 24 weeks after the last treatment, including any touch-ups At the conclusion of the randomized trial, an open-label, extended follow-up study included observations out to approximately 1.5 years after the last treatment to determine long-term safety and effectiveness Effectiveness of treatment was assessed at least once per month for the 6-month period of the randomized trial by the blinded evaluating investigator as well as by patients, using the 5-point NFL Severity Scale (NLFSS) with ratings ranging from 0 for none to 4 for extreme To evaluate safety and tolerability, subjects were instructed to keep a diary and record any treatment-site reactions for 2 weeks after each treatment
We will now discuss the JUVÉDERM ® open-label extended follow-up study After completing 24 weeks of the pivotal trial, subjects were offered a complimentary treatment with their preferred product at their convenience 1 Upon their return, they were first assessed by the treating investigator. They were then re-treated, up to approximately 1.5 years after their last treatment 2 More than three-quarters of JUVÉDERM ® subjects were evaluated during the extended trial 1 These subjects were representative of the pivotal trial subjects in terms of baseline NLF severity, NLF severity at week 24, and initial injection volume 1
The 2 graphs on this slide show the percentage of subjects with clinically significant improvement following optimal correction with JUVÉDERM ® Ultra and JUVÉDERM ® Ultra Plus 1 Note that those beyond 12 months are a subset of the beyond-9-month group 1 A total of 75% of the subjects treated with JUVÉDERM ® Ultra maintained improvement beyond 9 months; 68% still had clinically significant improvement beyond 1 year 1 Beyond 12 months, 78% of JUVÉDERM ® Ultra Plus injectable gel subjects still demonstrated at least a 1-point improvement in NLF severity 1 Through the extended study, both JUVÉDERM ® formulations have proven to be highly effective, with visible improvement over an extended period of time (more than 9 months) 1
This analysis evaluated the performance of JUVÉDERM ® Ultra Plus in sustaining correction in the subset of 87 pivotal trial subjects with severe NLFs. (This corresponds with a grade 3 on the NLFSS) 1 This graph compares the proportion of subjects with clinically significant improvement in NLF severity at 6 months and 1 year or more 1 Clinical significance was previously defined as a 1-point or greater reduction in NLF severity. The first 2 bars indicate that a substantial proportion of subjects, more than 80%, still experienced clinical benefit even after 1 year. These values were observed before the subjects had any repeat treatments 1 Let’s take a look at the second set of bars. Although it was not required by the study, we calculated the proportion of subjects exhibiting a 2-point or greater improvement in NLF severity. The proportion still experiencing improvement beyond 12 months was a little over one-third 1
This JUVÉDERM ® Ultra Plus subject presented approximately 17 months after last treatment¹ The duration of JUVÉDERM ® results, 17 months after initial treatment, speaks for itself¹ The results may not be typical
In summary, the JUVÉDERM ® Family of Hyaluronic Acid Fillers offers long-lasting clinical improvement of 1 point or more for up to 1 year 1 The majority of subjects in both arms maintained a clinically significant improvement JUVÉDERM ® Ultra for > 9 months, 75%¹ JUVÉDERM ® Ultra Plus for > 12 months, 78%¹ JUVÉDERM ® Ultra Plus for severe NLFs, (> 12 months) 81% 2 Repeat treatment required only about half the volume used for the initial treatment¹ There were no treatment-related adverse events other than injection-site reactions¹ All these findings confirm that the scientists at Allergan, Inc., achieved the clinical profile they targeted when designing these new-generation HA fillers
The purpose of this study was to assess the dose response of various HA fillers to commercially available ovine testicular hyaluronidase (OTH) Based on the varied degree of enzymatic degradation of commercially available fillers to hyaluronidase that has been reported in the literature, and due to the different HA concentration of the fillers studied in this series of tests, it was anticipated that the degradation patterns of the fillers would differ. Therefore, variable methods were used 1 : Variable doses of OTH (0 U to 40 U) for a fixed period of time (30 minutes) Incubation of JUVÉDERM ® with 20 U OTH for 30, 60, and 120 minutes; and 24 hours The amount of soluble HA and molecular weight of the test products was determined by size-exclusion chromatography coupled with a multiangle light scattering detector. In this study, the definition of soluble HA includes the uncross-linked HA added during its manufacturing process, as well as lightly cross-linked chains and gel fragments generated as degradation products of the gel network. An increase in total soluble HA will therefore indicate degradation of the HA network
JUVÉDERM ® showed greater resistance against in vitro enzymatic degradation by OTH compared with Restylane ®1 After incubation with 20 U of OTH for 30 minutes, percentage soluble “free” HA was 18.5% and 87.9% for JUVÉDERM ® and Restylane ® , respectively The percent soluble HA after incubating with 40 U of OTH for 30 minutes was 27.6% and 90.4% for JUVÉDERM ® injectable gel and Restylane ® , respectively After 24 hours of incubation with 40 U of OTH, the percent soluble HA of JUVÉDERM ® was 88.4%
Next, let’s discuss the utility and versatility of the JUVÉDERM ® Family of Hyaluronic Acid Fillers in clinical practice The JUVÉDERM ® Ultra Plus XC side of the model’s face depicts wrinkles and folds typically injected with this formulation These include NLFs, oral commissures, and marionette lines Now let’s take a look at the JUVÉDERM ® Ultra XC side of the model’s face The typical areas for JUVÉDERM ® Ultra and JUVÉDERM ® Ultra XC use include vertical lip lines, oral commissures, NLFs, marionette lines, and chin wrinkles (Physicians, please add your own experience for optimal on-label uses) We have seen that it is a combination of chemical and physical attributes that allows for JUVÉDERM ® and JUVÉDERM ® XC to each play an important role in facial aesthetics. The choice of which filler to use should be decided based on subject desire and need as well as injector’s experience and ease of use. However, together, both products provide the versatility injectors require in their filler armamentarium
JUVÉDERM ® is now available in both lidocaine and nonlidocaine formulations for your convenience This table highlights all of the JUVÉDERM ® products and the syringe sizes available for each product
JUVÉDERM ® XC sets the standard for hyaluronic acid (HA) fillers. Product characteristics include: Smooth flow—smooth-consistency gel with even and consistent extrusion force formulated with lidocaine Smooth comfort—provides a more comfortable patient experience vs the nonlidocaine JUVÉDERM ® formulation 1-3* Smooth outcomes—the only HA filler FDA approved † to last up to 1 year with initial treatment 1,2, ‡