Introductory Botulinum Presentation

s i m p l e

younger

rejuvenated

refreshed

New Technologies for Facial Enhancement

Introductory course to Vistabel

Course Agenda

• Starting off with Botox • Neurotoxin Pharmacology • Contraindications and Cautions • Patient selection and treatment options • Dilution and storage

Cont’ • Technique tips • Cosmetic indications 6. Glabellar frown lines 7. Forehead lines 8. Crows feet

Cont’ • • • •

Live demonstration Hands-on workshop Advanced techniques Strategies for success

UK APPROVAL 2006 For Glabellar frown lines BOTOX (100 Units) Now launched as VISTABEL (50 Units) Single patient use

Developing A Botulinum Toxin Practice Why develop an injection practice? - Cosmetic surgery trends favour minimally invasive techniques - No down time considered lunchtime procedure - Nonsurgical procedures growing at a faster pace than surgical - Want as opposed to need!!!!!!!

Personal Communication © Tim Flynn

Surgical & Non-surgical Cosmetic Procedures 9 Year - Comparison 1997-2005 Liposuction (lipoplasty) Breast Augmentation Eyelid Surgery BOTOX®

455,489

176,863

2005

364,610

101,176

231,467

159,232

65,157

3,294,782

Chemical Peel Laser Skin Resurfacing

1997

556,172

481,227

485,690

154,153

Top 5 nonsurgical cosmetic procedures in 2005 Chemical Peels

Microdermabrasion

Injectable Fillers

Laser Hair Removal

BOTOX®

556,172

1,023,931

1,194,222

1,566,909

3,294,782 American Society for Aesthetic Plastic Surgery

What Has Made Botulinum Toxin Type A a Popular Treatment? Patient satisfaction - Happy patients return more regularly for treatment

Physician satisfaction - VISTABEL® provides the cornerstone of rejuvenation treatments of the ageing face

Personal Communication © Ph LEVY

Patients perceive a “hierarchy” in cosmetic maintenance

Alteration

Visible Changes

Renovation

Subtle, natural changes

Prophylaxis

Containment

Altering appearance ; major interventions, eg. Face-Lift Improving appearance via NON-surgical treatments, eg. VISTABEL®, FILLERS Preserving appearance as a part of everyday care, eg. Anti-wrinkle creams

Cosmetic Maintenance “Context” Research 2004 Paris, France

Impact Of Wrinkles On Client’s Life Just under 50% of the clients considered that wrinkles had a considerable impact on their life

Patients’ level of agreement with the following statements

Score *

Wrinkles are a constant reminder of growing old

4.0

Having wrinkles depresses me

3.5

Having wrinkles reduces my self esteem

3.5

Having wrinkles impacts on my personal relationships

3.4

Having wrinkles impacts on my social life

3.3

Having wrinkles impacts on my career / work opportunities and success

3.0

Having wrinkles is just part of growing older and nothing to be too worried about

2.5

*Mean score on a scale from 1 (strongly disagree) to 5 (strongly agree)

“Genactis” Research 2004 France

Patients Feeling Towards Recommending Treatment To A Friend More than 90% of patients would recommend treatment to a friend concerned about wrinkles

Neither Recommend for nor against 10%

Recommend Against 0%

Strongly Recommend Against 0%

Strongly Recomment 38%

Recommend 52%

“Genactis” Research 2004 France

Age Under 18

0.05

18 - 24

0.16

25 - 34

32%

35 - 44

23%

45 - 54

17%

55 - 64

7%

65 +

1% 0%

5%

10%

15%

20%

25%

30%

35%

N=1335 Vivid Interface Ltd. Market Research Body Beautiful 2005

It is very important ® to learn that BOTOX is both an art and a science before you become a user

Art and Science combined

Starting BOTOX

®

How can you introduce it into your practice?

Starting BOTOX®

Starting BOTOX® Getting started with BOTOX can be ®

the hardest part… collecting patients, promoting it in the practice, consent forms…

Starting BOTOX®

Before offering BOTOX® to patients • Attend a training course • Review literature • Develop a consent form(provided) • Practice on partner, mother, close friend • Share data with staff. • Obtain suitable insurance cover Starting BOTOX®

Launching it in your Practice – consider the following: • Train reception staff to discuss the procedure • Do some initial free treatments on staff and best patients for word of mouth advertising • Build a before and after photo library to show prospective patients Starting BOTOX®

Launching it in your Practice – consider the following: • Schedule “BOTOX® days” • Get local media exposure • Inform patients with practice newsletter

Starting BOTOX®

Neurotoxin Pharmacology

Indicated for*; -Blepharospasm -Strabismus (USA) -Hemifacial spasm -Cervical dystonia -Cerebral Palsy -Axillary hyperhidrosis -Glabellar lines

*Approvals and product names vary from country to country – consult specific prescribing information

BOTOX® Photos © J Jankovic

Other Clinical Conditions Treated with BOTOX® (Un-licensed)

•Migraine •Tension Type Head-Ache •Back Ache •Hypersalivation •Myofacial Pain Syndrome Neurotoxin Pharmacology

Botulinum Neurotoxin Serotypes • 1982 Jean Carruthers to San Francisco to work with Alan Scott – one of early coinvestigators in FDA study • 1982 Jean Carruthers brings “Oculinum” into Canada • 1987 Jean Carruthers Blepharospasm patient comments on improvement in her wrinkles

Neurotoxin Pharmacology

Botulinum Neurotoxin Serotypes COOH

NH2

• Seven serotypes - A, B, C1, D, E, F, G - Type A has longest

S-S

Light duration Chain

Heavy Chain

of action • Intracellular target varies

NH2

- SNAP-25 • Does not penetrate the skin • No topical application

S S

COOH

Neurotoxin Pharmacology

BOTOX® - Mode of Action

1 Before BOTOX®:

2 Binding:

3 Internalization:

Endplate sits upon muscle fibre

Neurotoxin binds to nerve terminal

Neurotoxin internalized via receptor-mediated endocytosis.

Neurotoxin Pharmacology

BOTOX® - Mode of Action

4 Blocking: Light chain blocks fusion of neurotransmitter vesicle with nerve membrane by cleaving SNAP-25.

5 Sprouting and reestablishment of sprouts: Endplate expands and collateral axonal sprouts emerge. Sprouts subsequently retract and are eliminated; Neurotoxin parent terminal isPharmacology reestablished.

PRODUCT SAFETY • Botox has long clinical history • Maximum dose per treatment session for Dystonia 400U • Cosmetic doses range between 24 to 70U • LD50 estimated to be 3000U • Wide margin of safety. • No relevant systemic effects observed

How Toxic Is Botulinum Toxin? Look at the Ratio of Therapeutic dose to Life Threatening dose - Digitalis

1:2

- Insulin

1:3

- Lidocaine (s.c.) 1:5 - Botulinum toxin-A

1:50

Heckmann M Hauzart 2000

Contraindications and cautions

Contraindications •

Pregnancy and Lactation

•Neuromuscular transmission disorders.(Myasthenia Gravis) • Co-administration with aminoglycoside antibiotics • Bleeding disorders or anticoagulant therapy •Patients with known hypersensitivity to any Contraindications & cautions ingredient in BOTOX®

Cautions • Lack

of patient co operation

•Unrealistic expectations •Local infection at injection site (active acne) •Dysmorphophobia •Unrealistic fear of systemic botulism

Contraindications & cautions

Patient Selection and treatment options

Glogau wrinkle scale

Patient Selection and Treatment Options

Glogau wrinkle scale Type I (No Wrinkles) Topical therapy However, check dynamic movement May treat as preventive therapy

Patient Selection and Treatment Options

Glogau wrinkle scale Type II (Wrinkles in Motion) BOTOX® plus topicals

Patient Selection and Treatment Options

Glogau wrinkle scale

Type III (Wrinkles at Rest) BOTOX® plus fillers •Treat with Botox first •Botox and filler have synergistic action

Patient Selection and Treatment Options

Glogau wrinkle scale

Type IV (Nothing but Wrinkles) Consider surgery

Patient Selection and Treatment Options

KEY ELEMENTS • Assess patient’s desires. Are they realistic? • Assess facial expression at rest and during animation • Evaluate tonicity of muscles 5. Kinetic 6. Hyperkinetic 7. Hypertonic

KEY ELEMENTS • Palpate muscles to assess mass • Assess brow position • Evaluate any asymmetries • Begin with recommended starting dosages add more units in 2 week intervals

Dilution & Storage

Dilution of Vial • Wipe bung of Botox and saline with alcohol and allow to evaporate • Vacuum should draw down saline • Volumes of 1ml to 2.5mls recommended • Use only Bacteriostatic saline

Dilution & Storage

Dilution of Vial • Volumes of 1ml to 2.5mls recommended • US FDA trial protocol uses 2.5cc • 1ml dilution allows greater control by reducing diffusion however more difficult to handle leading to increased wastage of expensive product. • Also minor injection errors with 1ml dilution may lead to unpleasant consequences for patient

Dilution & Storage

Storage • Unreconstituted can store in fridge or freezer • DO NOT FREEZE BOTOX® ONCE RECONSTITUTED - Ice crystals may form which damage the toxin and reduce potency • Store in the refrigerator at 2 – 4 °C • As a general rule store in fridge at all times

Dilution & Storage

DILUTION 100 units botox in 2.5mls 20 units of botox in 0.5mls 2 units of botox in 0.05 mls 4 units of botox in 0.1mls Each major gradation is 2 units

DILUTION 50 units Vistabel in 1.25mls 20 units of Vistabel in 0.5mls 2 units of Vistabel in 0.05 mls 4 units of Vistabel in 0.1mls Each major gradation is 2 units

Some general technique tips for: • optimal treatment success • satisfied, repeat patients

General Injection Technique Tips • Patient should be seated or slightly reclining to best observe facial expressions • The treatment should be pleasant or, at least, comfortable to encourage repeat visits. Relax the patient & talk soothingly to lessen perceived pain • Thoroughly cleanse areas prior to injection, avoid alcohol as drying to skin and may interfere with Botox.

Technique Tips

General Injection Technique Tips • Try to change 30 gauge needle after every 4 - 5 injections. A sharp needle is less painful! • Gloves should be worn at all times, check for latex allergy • Mark injection sites prior to injection – remember to use a non tattooing pen • Record technique thoroughly on a patient worksheet so you can duplicate successful treatment and modify over- or under treatment.

Technique Tips

General Injection Technique Tips • Have patients discontinue aspirin,Vit E and NSAIDS, 7 days prior to treatment, to decrease bruising • Or at least warn patients of increased risk of bruising • Hold a gauze pad in the non-injecting hand so you can apply gentle pressure to any site that bleeds to minimise chances of bruising

Technique Tips

Preparing to Inject • Have the patient contract the muscles • Mark (when learning) the injection sites • Inject selected dose with 30 gauge needle • Inject with patient’s muscle relaxed for comfort

Technique Tips

CHECK LIST • Med history • Assess expectations • Explain 2 to 3 days before visible signs, 14 days for maximum effect • History,Skin status

Cont’ • Explain likely results discuss alternatives • Peels,microdermabrasion,Laser resurfacing • Sign consent form • Photograph, Inject, Record • Follow up instructions recall

Cosmetic Indications • Glabellar Frown Lines • Forehead Lines • Crow’s Feet • Eyebrow lift

Glabellar Frown Lines

• Convey negative emotions such as anger, depression,fatigue,biterness,disappointment and envy • Consider utilising in younger individuals as habit breaker.Muscle group may atrophy in time allowing longer duration of action • Women require 20 to 30U, Men 30 to 40U assess individually

Target Muscles for Frown Lines Procerus

Corrugators

Cosmetic Indications

Muscles of the Glabellar Complex Muscles Corrugator

Function Brow adductor (depressor) •

Procerus

Brow depressor •

Orbicularis oculi (medial); also known as depressor supercilii

Moves eyebrow downward and medially

Depresses medial head of eyebrow; can produce transverse lines on nasal dorsum

Brow depressor

Carruthers J Fagien S et al Plast Reconstr Surg 2004

Treating Glabellar Lines: Consensus Recommendations Higher starting doses may be used depending on individual patient variables

Target Muscles

Corrugator, procerus, depressor supercilii, orbicularis oculi, frontalis

Usual Number of Injection Points (Range)

Total Starting Dose* (Usual Range)

5 to 7; men may require more sites

Women: 20 to 30 U Men: 30 to 40 U

Carruthers J Fagien S et al Plast Reconstr Surg 2004

Frown lines – Injection sites

Cosmetic Indications - Glabellar Frown Lines

Glabellar Frown Lines Post-injection: Advise patient to frown as much as possible for 1 hour

Cosmetic Indications - Glabellar Frown Lines

Injection Technique (2) Pinching stabilizes the patient Pinching the facial skin with the non-dominant hand is helpful to control injection Allows subtle feeling of needle entering muscle Helps identify an intramuscular injection

Photo © Tim Flynn

Glabellar Frown Lines – How not to inject! Injecting down toward the globe Patient supine No gloves!

Cosmetic Indications - Glabellar Frown Lines

Results (1)

Photos © Hervé Raspaldo

Clinical Examples Female in her Thirties Before

30 Days

120 Days

Glabellar Frown Lines - Follow Up • Patients to return in 2 weeks to: - assess results/technique - photograph patient - touch up (if necessary) • Re-injection schedule - Patient dependent - 3 - 4 month intervals for first year - Less frequent after repeated treatments

Cosmetic Indications - Glabellar Frown Lines

Horizontal Forehead Lines

Anatomy - Frontalis Muscle Action: elevate brows, draw scalp posteriorly

Frontalis muscle

Cosmetic Indications - Horizontal Forehead Lines

Horizontal Forehead Lines: Anatomy and Physiology Muscle Frontalis

Function Brow elevation

(interacts with procerus, corrugators, and orbicularis oris)

Carruthers J Fagien S et al Plast Reconstr Surg 2004

Horizontal Forehead Lines •

Leave some facial expression do not paralyze

• Use minimal dose to produce desired effect • Males have more muscle mass • Assess pre-existing brow position prior to deciding on frontalis doseage and injection sites • Look for any brow asymmetry

Cosmetic Indications - Horizontal Forehead Lines

Horizontal Forehead Lines • Approach should be conservative - 10-20 Units BOTOX® in several divided doses • In the lateral to mid-pupillary line, stay at least 1 finger width above the supra-orbital rim Avoid ptosis by not injecting shaded area

Cosmetic Indications - Horizontal Forehead Lines

Clinical Examples Female in her Thirties Before

30 Days

120 Days

Horizontal Forehead Lines

Standard technique: 2-4 units in 5 injection sites

Cosmetic Indications - Horizontal Forehead Lines

Horizontal Forehead Lines

Additional sites to consider for males

Cosmetic Indications - Horizontal Forehead Lines

Horizontal Forehead Lines

Before

After

Cosmetic Indications - Horizontal Forehead Lines

Horizontal Forehead Lines

Before

After Note enhancement of brow shape to soft flare

Cosmetic Indications - Horizontal Forehead Lines

Crow’s Feet

Target Muscles for Crow’s Feet Orbicularis oculi

Cosmetic Indications - Crow’s Feet

Crow’s Feet • Caution in patients with eyebags may make worse • Assess skin laxity and dlfferentiate between dynamic movement and skin ageing • Be guarded with prognosis in individuals with laxity and aged skin • Look closely for blood vessels and avoid • The orbicularis oculi is a superficial muscle – there is no need to inject deeply

Cosmetic Indications - Crow’s Feet

Crow’s Feet • Patient at full smile • Note upper and lower borders of the crow’s feet

Cosmetic Indications - Crow’s Feet

Crow’s Feet • Inject 1cm outside the orbital rim • At least 3 injection sites 1cm apart suffice due to diffusion effect • Inject 3 - 4 units of BOTOX® per injection site

x x

REQUIRED

x OPTIONAL- IF PATIENT HAS LINES

Cosmetic Indications - Crow’s Feet

Clinical Examples Female in her Thirties Before

30 Days

120 Days

Crow’s Feet

Before

After

Cosmetic Indications - Crow’s Feet

Managing complications of BOTOX® treatment

Potential Side Effects • Bruising is the most common side effect • Avoid obvious blood vessels • Apply gentle pressure to bleeding area • Drooping of eyebrow • Transient headache • Nausea • Diplopia

Managing complications

Potential complications Bruising Headache Eyelid ptosis Brow ptosis Brow repositioning Diplopia

Managing complications

Treating ptosis Alpha-2 agent with weak alpha-1 activity [eg, apraclonidine 0.5% (Iopidine®] Alpha-1 adrenergic stimulation of Müller’s muscle

Managing complications

Treating ptosis Usually resolves in 1-6 weeks Iopidine (Alcon) eyedrops 1 drop q.i.d. will temporarily resolve

Ptosis left lid

20 minutes after Iopidine®

Managing complications

Brow ptosis Wait for natural resolution Consider infrabrow injection at arch and laterally to raise brow

After BOTOX® to glabellar and brow

Managing complications

Brow repositioning Excessive brow elevation • “Quizzical” or “Mr Spock” brows • Correct with 1 to ® 2units of BOTOX injected into the frontalis above the lateral brow

Managing complications

If after glabella treatment “cruella” / mephisto inject 0.5-1.5U only

‘Mephisto’ Photo © Ph LEVY

Advanced techniques require a degree of judgement gained from approximately 3-6 months BOTOX® cosmetic experience

Advanced Cosmetic Techniques • Suborbital region • Upper lip wrinkles • Nasal scrunch (“bunny lines”) • Nasolabial folds & marionette lines • Platysmal bands

Advanced techniques and combination treatment

Before

After

Infra Orbital Crinkle Lines Photos© Ph LEVY

Before

After

Bunny Lines Results Photos © K De Boulle

Before

After

Perioral Rhytides Photos © K De Boulle

Chin: Peau D’orange, Mental Crease

Before

After

Photos © NJ Lowe

Marionnette Lines Or Sad Corners Of The Mouth Uplifts corners of the mouth Technique: 1.5–3U into each depressor anguli oris muscle Injection site -7mm lateral , 8mm caudal OR mandib. border

© Ph LEVY

Before

35-55 y.o.

After

Neck - Anterior bands Photos © Ph LEVY

Strategies for success

Choice of Language Medical Phrases

Patient Positive Phrases

Frozen

Smooth

Toxin

Purified or natural protein

Paralyse

Relax or soften muscle activity

Pain

Minimal discomfort

Weaken

Relax

Customer service • Prompt service availability is essential

•Offer free consultation • The wait time for BOTOX® is best kept short • Try and arrange BOTOX® days for efficient use of material • Always have material available!!!!!!!!

Strategies for success

Pricing Policy • In the UK pricing tends to be by facial areas • Be consistent in your pricing policy with single versus 3 areas • Provide top up treatment free of charge

Strategies for success

Marketing

Don’t advertise BOTOX® or “Botulinum toxin”it contravenes Advertising Standard Authority guidelines regarding the promotion of Prescription Only Medicines.

Strategies for success

Tips to avoid Disappointment • Offer free consultation prior to treatment for first time treatment • Make sure that you and the patient have realistic outcome objectives • When treatment results are not up to expectations, assess situation and top up if appropriate • Consider non responder(rare)

Strategies for success

Cont’ • If results are minimised because of additional muscle recruitment, explain with a mirror • Some movement may return after only 28 days • Refer patients back to initial photographs • Make no guarantees concerning duration. Ranges are from 2 – 6 months

Strategies for success

Optimizing Success BOTOX /VISTABEL considered by ®

many cosmetic practitioners to be the most successful cosmetic procedure available due to patient demand, level of satisfaction and relative ease of placement.

Strategies for sucess

Conclusion Long-term treatment with boNTA can prevent the development of imprinted facial lines that are visible at rest Such treatment is well tolerated, with no adverse events reported during 13 years of regular treatment in this study

Binder WJ AAD 2006

What Makes A Clinician Confident Using VISTABEL®? Reproducible efficacy and safety with his/her patients Satisfied patients Increasing demand for treatment Demonstrated long term safety profile Number and quality of supporting publications Ongoing basic and clinical research Active support and training

Reconstitution BOTOX 100 units per vial Reconstitute 2.5 mls Bacteriostatic saline 100 units in 2.5mls 20units in 0.5 mls 2 units in 0.05 mls (marked 5) 4 units in 0.1 mls (marked 10) VISTABEL 50 units per vial(half of Botox vial) dilute with1.25mls Bacteriostatic saline and use unit measurements as above.

CONSENT FORM Contraindications:You cannot receive Botox/Dysport if you are in the following categories : Pregnant or Breast Feeding Neuromuscular disorders/Myasthenia Gravis/Eaton Lambert Syndrome Blood Coagulation Disorders or taking anticoagulants. Currently taking Aminoglycoside antibiotics,Spectinomycin or Muscle relaxants. Potential Side Effects(temporary) Bruising /Swelling/Redness at injection site Nausea/Headache Occasional numbness Drooping of the Eyebrow or upper Eyelid Allergic reactions Brief visual disturbances Consent for Botox/Dysport Treatment All foreseeable risks of Botulinum toxin therapy listed above have been thoroughly explained to me.My questions regarding the treatment procedure,its potential side effects and contraindications were answered to my full satisfaction. I also had adequate time to consider my decision. I understand that I am free to revoke my consent at any time. I consent to the administration of Botox/Dysport and have been given after care instructions.This consent form is also signed for future administration of Botox/Dysport. Patient’s Name…………………………… Date……………….. Signature of Patient……………………… Witnessed by (Signature of Physician)………………………………..

POST TREATMENT INSTRUCTIONS 1) Exercise muscles treated for 1 hour 2) Remain Upright for 3-4 hours 3) No chemical peels, sun beds or laser treatment for 7 days 4) Muscle weakening may not be evident for 3 days and may take as long as 10 days.

Useful Numbers Wigmore Pharmacy 23 Wigmore Street London W1U 1PL Tel: 0207 4910111 Botox,0.5ml diabetic syringes 30ml 0.9% Bacteriostatic saline Iopidine 5mg/ml eye drops Hamilton Fraser Insurance Solutions(HFIS) Tel: 0845 3106319(Jeanette Turner) Steven Kaldor [email protected] 07801428702 Allergan Ltd(Vistabel) 08003767965 Richard Crawford 0773358145(Rep)

Thank you