introductory botulinum presentation

New Technologies for Facial Enhancement

s i m p l e

y o u n g e r

r e j u v e n a t e d

r e f r e s h e d

Introductory course to Vistabel

• Starting off with Botox• Neurotoxin Pharmacology

• Contraindications and Cautions• Patient selection and treatment options

• Dilution and storage

Course AgendaCourse Agenda

• Technique tips• Cosmetic indications1. Glabellar frown lines

2. Forehead lines3. Crows feet

Cont’Cont’

• Live demonstration• Hands-on workshop

• Advanced techniques• Strategies for success

Cont’Cont’

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

Top 5 nonsurgical cosmetic procedures in 2005 Top 5 nonsurgical cosmetic procedures in 2005

American Society for Aesthetic Plastic Surgery

Surgical & Non-surgical Cosmetic Procedures 9 Year - Comparison

1997-2005 1997

154,153

481,227

65,157

159,232

101,176

176,863

485,690

556,172

3,294,782

231,467

364,610

455,489

Laser Skin Resurfacing

Chemical Peel

BOTOX®

Eyelid Surgery

Breast Augmentation

Liposuction (lipoplasty)

556,172

1,023,931

1,194,222

1,566,909

BOTOX®

Laser Hair Removal

Injectable Fillers

Microdermabrasion

Chemical Peels

3,294,782

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

Cosmetic Maintenance

Patients perceive a “hierarchy” in cosmetic maintenance

Alteration Visible Changes Altering appearance ; major interventions, eg.

Face-Lift

Renovation Subtle, natural changes

Improving appearance viaNON-surgical treatments, eg. VISTABEL®, FILLERS

Prophylaxis Containment Preserving appearance as a part of everyday care,

eg. Anti-wrinkle creams

“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 against10%

Recommend52%

Strongly Recomment

Strongly Recommend

Against0%

Recommend Against

“Genactis” Research 2004 France

0% 5% 10% 15% 20% 25% 30% 35%

55 - 64

45 - 54

35 - 44

25 - 34

18 - 24

Under 18

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

Art and Science combined

It is very importantIt is very important

to learn that BOTOXto learn that BOTOX®® is both an is both an

artart and a and a science science before you become a userbefore you become a user

Starting BOTOXStarting BOTOX®®

How can you introduce it into

your practice?

Starting BOTOX®

Starting BOTOXStarting BOTOX®®

Getting started with BOTOX® can be the

hardest part…

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

Before offering BOTOXBefore offering BOTOX®® to patients 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 Launching it in your Practice – consider the following:– 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 – Launching it in your Practice – consider the following:consider the following:

• Schedule “BOTOX® days”

• Get local media exposure

• Inform patients with practice newsletter

Starting BOTOX®

NeurotoxinNeurotoxin

PharmacologyPharmacology

BOTOX®

Indicated for*;

-Blepharospasm

-Strabismus (USA)

-Hemifacial spasm

-Cervical dystonia

-Cerebral Palsy

-Axillary hyperhidrosis

-Glabellar lines

Photos © J Jankovic

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

Other Clinical Conditions Treated with Other Clinical Conditions Treated with

BOTOXBOTOX® (Un-licensed)® (Un-licensed)

Neurotoxin Pharmacology

•Migraine

•Tension Type Head-Ache

•Back Ache

•Hypersalivation

•Myofacial Pain Syndrome

Botulinum Neurotoxin SerotypesBotulinum Neurotoxin Serotypes

• 1982 Jean Carruthers to San Francisco to work with Alan Scott – one of early co- investigators in FDA study

• 1982 Jean Carruthers brings “Oculinum” into Canada

• 1987 Jean Carruthers Blepharospasm patient comments on improvement in her wrinkles

• Seven serotypes

- A, B, C1, D, E, F, G

- Type A has longest duration

of action

• Intracellular target varies

- SNAP-25

• Does not penetrate the skin

• No topical application COOH

HeavyChain

LightChain

Botulinum Neurotoxin SerotypesBotulinum Neurotoxin Serotypes

BOTOXBOTOX® - Mode of Action® - Mode of Action

1 Before BOTOX®:

Endplate sits upon muscle fibre

2 Binding:

Neurotoxin binds to nerve terminal

3 Internalization:

Neurotoxin internalized via receptor-mediated endocytosis.

BOTOXBOTOX® - Mode of Action® - Mode of Action

4 Blocking:

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

5 Sprouting and re-establishment of sprouts:

Endplate expands and collateral axonal sprouts emerge. Sprouts subsequently retract and are eliminated; parent terminal is re-established.

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

- Digitalis 1:2

- Insulin 1:3

- Lidocaine (s.c.) 1:5

- Botulinum toxin-A 1:50

Heckmann M Hauzart 2000

Contraindications and Contraindications and cautionscautions

ContraindicationsContraindications

Contraindications & cautions

• Pregnancy and Lactation •Neuromuscular transmission disorders.(Myasthenia Gravis)

• Co-administration with aminoglycoside antibiotics

• Bleeding disorders or anticoagulant therapy

•Patients with known hypersensitivity to any ingredient in BOTOX®

CautionsCautions

Contraindications & cautions

• Lack of patient co operation

•Unrealistic expectations

•Local infection at injection site (active acne)

•Dysmorphophobia

•Unrealistic fear of systemic botulism

Patient Selection and Patient Selection and treatment options treatment options

Patient Selection and Treatment Options

Glogau wrinkle scaleGlogau wrinkle scale

Type I (No Wrinkles) Topical therapyHowever, check

dynamic movementMay treat as

preventive therapy

Type II (Wrinkles in Motion)

BOTOX® plus topicals

Type III (Wrinkles at Rest) BOTOX® plus fillers

•Treat with Botox first•Botox and filler have

synergistic action

Type IV (Nothing but Wrinkles)

Consider surgery

KEY ELEMENTS• Assess patient’s desires. Are they realistic?

• Assess facial expression at rest and during animation

• Evaluate tonicity of muscles

1. Kinetic

2. Hyperkinetic

3. 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 &Dilution &

StorageStorage

Dilution & Storage

Dilution of VialDilution 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 VialDilution 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

StorageStorage• 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 Some general technique tips for:technique tips for:

• optimal treatment success

• satisfied, repeat patients

General Injection Technique TipsGeneral 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

• 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

• 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

• 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

Preparing to InjectPreparing to Inject

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

• Glabellar Frown Lines• Forehead Lines

• Crow’s Feet

• Eyebrow lift

Cosmetic IndicationsCosmetic Indications

GlabellarGlabellar

Frown LinesFrown 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

Procerus

Corrugators

Target Muscles for Frown LinesTarget Muscles for Frown Lines

Cosmetic Indications

Muscles of the Glabellar Complex

Muscles Function

Corrugator Brow adductor (depressor)

• Moves eyebrow downward and medially

Procerus Brow depressor

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

Orbicularis oculi (medial); also known as depressor supercilii

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

Usual Number ofInjection Points

(Range)

Total Starting Dose*

(Usual Range)

Corrugator, procerus, depressor supercilii, orbicularis oculi, frontalis

5 to 7; men may require more sites

Women: 20 to 30 UMen: 30 to 40 U

Frown lines – Injection sitesFrown lines – Injection sites

Cosmetic Indications - Glabellar Frown Lines

Post-injection: Advise patient to frown

as much as possible for 1 hour

Glabellar Frown LinesGlabellar 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 Glabellar Frown Lines – How not to inject!not to inject!

Injecting down toward the globe

Patient supine

No gloves!

Results (1)

Photos © Hervé Raspaldo

Clinical ExamplesFemale in her Thirties

Before

30 Days

120 Days

• 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

Glabellar Frown Lines - Follow UpGlabellar Frown Lines - Follow Up

HorizontalHorizontal

Forehead LinesForehead Lines

Anatomy - Frontalis MuscleAnatomy - Frontalis Muscle

Action: elevate brows, draw scalp posteriorly

Frontalis muscle

Cosmetic Indications - Horizontal Forehead Lines

Horizontal Forehead Lines:Anatomy and Physiology

Muscle Function

Frontalis

(interacts with procerus, corrugators, and orbicularis oris)

Brow elevation

Horizontal Forehead LinesHorizontal 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

• 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 bynot injecting shaded area

Before

30 Days

120 Days

Standard technique: 2-4 units in 5 injection sites

Additional sites to consider for males

Before After

Note enhancement of brow shape to soft flare

Before After

Crow’s FeetCrow’s Feet

Orbicularis oculi

Target Muscles for Crow’s FeetTarget Muscles for Crow’s Feet

Cosmetic Indications - 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

• Patient at full smile

• Note upper and lower borders of the 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

OPTIONAL- IF PATIENT HAS LINES

REQUIRED

Before

30 Days

120 Days

Before After

Managing complications Managing complications

of BOTOXof BOTOX® treatment® treatment

• Bruising is the most common side effect

• Avoid obvious blood vessels

• Apply gentle pressure to bleeding area

• Drooping of eyebrow

• Transient headache

• Nausea

• Diplopia

Potential Side EffectsPotential Side Effects

Managing complications

Potential complicationsPotential complications

BruisingHeadacheEyelid ptosisBrow ptosisBrow repositioningDiplopia

Treating ptosisTreating ptosis

Alpha-2 agent with weak alpha-1 activity [eg, apraclonidine 0.5% (Iopidine®]

Alpha-1 adrenergic stimulation of Müller’s muscle

Treating ptosisTreating ptosis

Managing complicationsPtosis left lid 20 minutes after Iopidine®

Usually resolves in 1-6 weeksIopidine (Alcon) eyedrops 1 drop q.i.d. will temporarily resolve

Brow ptosisBrow ptosis

Wait for natural resolution

Consider infrabrow injection at arch and laterally to raise brow

After BOTOX® to glabellar and brow

Excessive brow elevation

• “Quizzical” or “Mr Spock” brows

• Correct with 1 to 2units of BOTOX® injected into the frontalis above the lateral brow

Brow repositioningBrow repositioning

‘Mephisto’

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

Advanced techniques require a degree Advanced techniques require a degree

of judgement gained from of judgement gained from

approximately 3-6 months BOTOXapproximately 3-6 months BOTOX®®

cosmetic experiencecosmetic experience

• Suborbital region

• Upper lip wrinkles

• Nasal scrunch (“bunny lines”)

• Nasolabial folds & marionette lines

• Platysmal bands

Advanced techniques and combination treatment

Advanced Cosmetic TechniquesAdvanced Cosmetic Techniques

Before After

Perioral Rhytides

Before After

Chin: Peau D’orange, Mental Crease

Before After

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

Neck - Anterior bands 35-55 y.o.

Maximum dose per session: 60U

Rather tight skin

Before After

Strategies for Strategies for successsuccess

Choice of LanguageMedical Phrases Patient Positive Phrases

Frozen Smooth

Toxin Purified or natural protein

Paralyse Relax or soften muscle activity

Pain Minimal discomfort

Weaken Relax

Strategies for success

Customer serviceCustomer 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!!!!!!!!

Pricing PolicyPricing 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 chargeProvide top up treatment free of charge

MarketingMarketing

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

Tips to avoid DisappointmentTips 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)

Cont’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

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.

Optimizing SuccessOptimizing Success

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

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

stevenkaldor@hotmail.com

07801428702

Allergan Ltd(Vistabel)

08003767965

Richard Crawford 0773358145(Rep)

Thank youThank you

introductory botulinum presentation

wrinkles impacts

france impact of wrinkles

following statements

france patients

cosmetic surgery trends

popular treatment

genactis research

glabellar frown lines

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