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BOTOX PARTY

Dr. Pravin Shaw
Non-Invasive Facial Rejuvenation:

      Injectables : BOTOX
The Aging Process on the Skin
• Collagen turnover is
  decreased
• Facial fat pads fall
• Facial volume is
  reduced
• Skin loses elasticity
The Aging Face




    Matarasso et al. Plast Reconstr Surg 2006;117(3 Suppl):3S-34S
Facial Rejuvenation Treatments

    •   Botulinum toxin
    •   Fillers
    •   Lasers
    •   Peels
    •   Topical products
Botulinum Toxin Type A
Botulinum Toxin Structure
 Clostridium botulinum is a gram positive, anaerobic, rod-shaped bacterium that
            produces seven serologically distinct neurotoxins (A-G)1.




    Non-toxic,
non-hemagglutinin
     (NTNH)




Hemagglutinin (HA)             150 kD Neurotoxin


                                    1Hathaway.   In: Hauschild AHW, ed. Clostridium Botulinum: Ecology and
                                      Control in Foods New York, NY: Marcel Dekker, Inc.;1993;54:pp 3-20.
                                                              2Inoue et al. Infect Immun 1996;64:1589-1594.
                                               3Lacy et al. Nat Struct Biol 1998;5:898-902 (with permission).
Normal Neuromuscular Function




Arnon et al. JAMA 2001;285(8):1059-1070 (with permission).
Botulinum Toxin Mechanism of Action




Arnon et al. JAMA 2001;285(8):1059-1070 (with permission).
Manufacturing and Formulation Comparison
                                       1BOTOX®                        2DYSPORT®                           3MYOBLOC®

         FIRST APPROVAL              • 1989                            • 1991                              • 2000
                 SEROTYPE            •A                                •A                                  •B
                    STRAIN           • Hall                            • NCTC 2916                         • Bean
      RECEPTOR/TARGET                • SV2/SNAP-25                     • SV2/SNAP-25                       • Syt II/VAMP
                  PROCESS            • Crystallization                 • Chromatography                    • Chromatography
            COMPLEX SIZE             • 900 kD*                         • > 500 kD^                         • 700 kD†
             UNIFORMITY              • Homogeneous                     • Heterogenous                      • Homogeneous
                                     • HSA                             • HSA                               • HSA
               EXCIPIENTS            • Sodium chloride                 • Lactose                           • Sodium Succinate
                                                                                                           • Sodium Chloride
          STABILIZATION              • Vacuum drying                   • Lyophilization                    • Solution
         SOLUBILIZATION              • Normal saline                   • Normal saline                     • N/A
                     pH              • ~7                              • ~7                                • 5.6
       UNITAGE (U/VIAL)              • 100                             • 500                               • 2500, 5000, 10000
      PROTEIN (ng/VIAL)              • <5                              • ≤12.5‡                            • ~25, 50, 100
1BOTOX   PI, Allergan, Inc., 2004; 2DYSPORT SPC, Ipsen, 2004; 3MYOBLOC PI, Solstice Neurosciences, 2004; *Schantz and Johnson.
Microbial Rev 1992;56:80-99; Allergan Inc., data on file, 2005; ^Hambleton. J Neurol 1992;239:16-20; †Setler. Neurology 2000:55(Suppl
5):S22-S28; ‡Pickett et al. Eur J Neurol 2007;14:e11.
Botulinum toxin
• Botulinum toxin type A (BoNT-A) works by blocking
  the release of a neurotransmitter necessary for
  muscles to contract

• The effects of BoNT-A last approximately 3-4 months,
  with complete re-activation of the nerves and
  muscles

• BoNT-A has been available and used for therapeutic
  uses since 1980
Botulinum toxin
• Botulinum toxin treatment has consistently been the
  top cosmetic procedure, with >2.7M procedures in
  2007

• Botulinum toxin type A for cosmetic use was
  approved in the U.S. in 2002 under the name “Botox
  Cosmetic”

• Botox Cosmetic is indicated for the temporary
  improvement of moderate to severe frown lines
Adverse events
• Adverse events to botulinum toxin treatment
  are usually mild and resolve on their own
  within a few days

• AEs include: headache, swelling, pain at the
  injection site, and bruising



                                      1Botox   Cosmetic PI
1. Frontalis
2. Procerus
3. Corrugator supercilli
4. Depressor supercilli
                                                       1
5. Temporalis
                               5
6. Obicularis oculi                               3

7. Nasalis                                                  2

8. Levator labaii superioris                                    4
   alaeque nasi
9. Levator labaii                  6

10. Zygomaticus minor                                 8    7
11. Zygomaticus major                   10        9
12. Obicularis oris                11
13. Modeolus                                               12
                                   13
14. Masseter
                                   14
15. Depressor anguli oris
16. Depressor labii                          15
                                                      16   17
17. Mentalis
Facial Areas Commonly Treated with BoNT-
                    A
     Forehead
                                   Glabellar lines
     Brow lift

                                    Bunny lines
  Crow’s feet

                                   Perioral lines
Gummy smile                       Oral
                                  commissures

                                   Peau d’orange
 Platsymal
     bands
BoNT-A treatment: Forehead lines

       Before                          After - Day 30




After - Day 120




                  Carruthers & Carruthers. Dermatol Surg 2007;33:S10-S17
BoNT-A treatment: Forehead lines


   Before                       After - Day 30




               Carruthers & Carruthers. Dermatol Surg 2003;29:461-67
X       X           X       X
Forehead
                X       X   X       X
Units
  Female:
  Male:
BoNT-A treatment: Glabellar lines

   Before              After - Day 30




                                        www.Botox.com
BoNT-A treatment: Glabellar lines



            After - Day 30




Before                       After - Day 120




                                     www.Botox.com
Glabella
Units
            X               X
  Female:       X       X
  Male:             X
BoNT-A treatment: Brow lift
   Before                           After




            Coleman & Carruthers. Dermatol Therap 2006;19:177-88
Brow lift
Units
  Female:       X               X
                    X       X
            X                       X
  Male:                 X
BoNT-A treatment: Perioral lines
   Before                        After




                Kane. Oral Maxillofacial Surg Clin N Am 2005;17:41-49
Perioral lines
Units
  Female:
  Male:




                 X X   X
                           X
BoNT-A treatment: Gummy smile
  Before                          After




              Kane. Oral Maxillofacial Surg Clin N Am 2005;17:41-49
Gummy smile
Units
  Female:
  Male:




              X   X
BoNT-A treatment: Oral commissures
    Before                           After




                Carruthers & Carruthers. Dermatol Surg 2003;29:468-76
Oral commisures
Units
  Female:
  Male:




                  X   X
BoNT-A treatment: Peau d’orange

  Before                          After




               Kane. Oral Maxillofacial Surg Clin N Am 2005;17:41-49
Peau d’orange
Units
  Female:
  Male:




                X X
BoNT-A treatment: Platsymal bands
      Before                         After




                Carruthers & Carruthers. Dermatol Surg 2003;29:468-76

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Botox Party

  • 2. Non-Invasive Facial Rejuvenation: Injectables : BOTOX
  • 3. The Aging Process on the Skin • Collagen turnover is decreased • Facial fat pads fall • Facial volume is reduced • Skin loses elasticity
  • 4. The Aging Face Matarasso et al. Plast Reconstr Surg 2006;117(3 Suppl):3S-34S
  • 5. Facial Rejuvenation Treatments • Botulinum toxin • Fillers • Lasers • Peels • Topical products
  • 7. Botulinum Toxin Structure Clostridium botulinum is a gram positive, anaerobic, rod-shaped bacterium that produces seven serologically distinct neurotoxins (A-G)1. Non-toxic, non-hemagglutinin (NTNH) Hemagglutinin (HA) 150 kD Neurotoxin 1Hathaway. In: Hauschild AHW, ed. Clostridium Botulinum: Ecology and Control in Foods New York, NY: Marcel Dekker, Inc.;1993;54:pp 3-20. 2Inoue et al. Infect Immun 1996;64:1589-1594. 3Lacy et al. Nat Struct Biol 1998;5:898-902 (with permission).
  • 8. Normal Neuromuscular Function Arnon et al. JAMA 2001;285(8):1059-1070 (with permission).
  • 9. Botulinum Toxin Mechanism of Action Arnon et al. JAMA 2001;285(8):1059-1070 (with permission).
  • 10. Manufacturing and Formulation Comparison 1BOTOX® 2DYSPORT® 3MYOBLOC® FIRST APPROVAL • 1989 • 1991 • 2000 SEROTYPE •A •A •B STRAIN • Hall • NCTC 2916 • Bean RECEPTOR/TARGET • SV2/SNAP-25 • SV2/SNAP-25 • Syt II/VAMP PROCESS • Crystallization • Chromatography • Chromatography COMPLEX SIZE • 900 kD* • > 500 kD^ • 700 kD† UNIFORMITY • Homogeneous • Heterogenous • Homogeneous • HSA • HSA • HSA EXCIPIENTS • Sodium chloride • Lactose • Sodium Succinate • Sodium Chloride STABILIZATION • Vacuum drying • Lyophilization • Solution SOLUBILIZATION • Normal saline • Normal saline • N/A pH • ~7 • ~7 • 5.6 UNITAGE (U/VIAL) • 100 • 500 • 2500, 5000, 10000 PROTEIN (ng/VIAL) • <5 • ≤12.5‡ • ~25, 50, 100 1BOTOX PI, Allergan, Inc., 2004; 2DYSPORT SPC, Ipsen, 2004; 3MYOBLOC PI, Solstice Neurosciences, 2004; *Schantz and Johnson. Microbial Rev 1992;56:80-99; Allergan Inc., data on file, 2005; ^Hambleton. J Neurol 1992;239:16-20; †Setler. Neurology 2000:55(Suppl 5):S22-S28; ‡Pickett et al. Eur J Neurol 2007;14:e11.
  • 11. Botulinum toxin • Botulinum toxin type A (BoNT-A) works by blocking the release of a neurotransmitter necessary for muscles to contract • The effects of BoNT-A last approximately 3-4 months, with complete re-activation of the nerves and muscles • BoNT-A has been available and used for therapeutic uses since 1980
  • 12. Botulinum toxin • Botulinum toxin treatment has consistently been the top cosmetic procedure, with >2.7M procedures in 2007 • Botulinum toxin type A for cosmetic use was approved in the U.S. in 2002 under the name “Botox Cosmetic” • Botox Cosmetic is indicated for the temporary improvement of moderate to severe frown lines
  • 13. Adverse events • Adverse events to botulinum toxin treatment are usually mild and resolve on their own within a few days • AEs include: headache, swelling, pain at the injection site, and bruising 1Botox Cosmetic PI
  • 14. 1. Frontalis 2. Procerus 3. Corrugator supercilli 4. Depressor supercilli 1 5. Temporalis 5 6. Obicularis oculi 3 7. Nasalis 2 8. Levator labaii superioris 4 alaeque nasi 9. Levator labaii 6 10. Zygomaticus minor 8 7 11. Zygomaticus major 10 9 12. Obicularis oris 11 13. Modeolus 12 13 14. Masseter 14 15. Depressor anguli oris 16. Depressor labii 15 16 17 17. Mentalis
  • 15. Facial Areas Commonly Treated with BoNT- A Forehead Glabellar lines Brow lift Bunny lines Crow’s feet Perioral lines Gummy smile Oral commissures Peau d’orange Platsymal bands
  • 16. BoNT-A treatment: Forehead lines Before After - Day 30 After - Day 120 Carruthers & Carruthers. Dermatol Surg 2007;33:S10-S17
  • 17. BoNT-A treatment: Forehead lines Before After - Day 30 Carruthers & Carruthers. Dermatol Surg 2003;29:461-67
  • 18. X X X X Forehead X X X X Units Female: Male:
  • 19. BoNT-A treatment: Glabellar lines Before After - Day 30 www.Botox.com
  • 20. BoNT-A treatment: Glabellar lines After - Day 30 Before After - Day 120 www.Botox.com
  • 21. Glabella Units X X Female: X X Male: X
  • 22. BoNT-A treatment: Brow lift Before After Coleman & Carruthers. Dermatol Therap 2006;19:177-88
  • 23. Brow lift Units Female: X X X X X X Male: X
  • 24. BoNT-A treatment: Perioral lines Before After Kane. Oral Maxillofacial Surg Clin N Am 2005;17:41-49
  • 25. Perioral lines Units Female: Male: X X X X
  • 26. BoNT-A treatment: Gummy smile Before After Kane. Oral Maxillofacial Surg Clin N Am 2005;17:41-49
  • 27. Gummy smile Units Female: Male: X X
  • 28. BoNT-A treatment: Oral commissures Before After Carruthers & Carruthers. Dermatol Surg 2003;29:468-76
  • 29. Oral commisures Units Female: Male: X X
  • 30. BoNT-A treatment: Peau d’orange Before After Kane. Oral Maxillofacial Surg Clin N Am 2005;17:41-49
  • 31. Peau d’orange Units Female: Male: X X
  • 32. BoNT-A treatment: Platsymal bands Before After Carruthers & Carruthers. Dermatol Surg 2003;29:468-76