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Vitiligo: my experience of 25 years and
            19.156 patients




                 Dr. Antonio Salafia
    Dermatologist & Head Dept. Reconstructive Surgery.
          Vimala Dermatological Centre, Mumbai

            St.Petersburg, Russia.
                 July 7th 2011
The experience of a clinician.
• In the early 1980’s I was disappointed with
    PUVA, so I explored other avenues:
 a) From the year 1980 Dapsone was used at Vimala
    Dermatological Centre, with some success.
 b) In 1983 I set a protocol:Dapsone, Vitamin
    B6 -suggested by C. Frati from IDI,Rome.
• In 1985 I began experimenting with new lotions,
    inspired by the work of Prota. (Protocol C).

                      Antonio Salafia
Protocol ‘C’
ORAL THERAPY:
• Dapsone: 0.5 mgs K/wt.
• Vitamin B6 100-300 mg. a day, Iron, Folic Acid.

LOCAL APPLICATION:
• Face: Locoid (Hydrocortisone Butyrate) Tacrolimus.
• Neck: Lotion A (the mildest).
• Body / Arms and Legs: Lotion B (strong).
• Arms, Legs, Hands, Feet : Lotion 5 –F (strongest).


                        Antonio Salafia
Dapsone: possible mode of action.
a) Antioxidant: a. Potent scavenger of free radicals (T. Ryan)
                b. Decreases H2O2 - as good as Catalase (Wozel).
                c. Weak inhibitor of prostaglandin synthesis.
                d. Scavenger of oxidative intermediates, and
                      suppressor of PMN (which produce ROS).

B) Decreases the level of Glutathione: skin of vitiligo patients has a
    higher content of Glutathione. By suppressing Glutathione we
    favor the formation of Eumelanins instead of Pheomelanins (Ito).

C) Possible beneficial effects.
     DDS is an immunomodulator + suppressor of PMN cells, hence
     effective in diseases wherein there is dense infiltrate of PMN:
     Dermatitis Herpetiformis, Subcorneal Pustular Dematosis, Scarring/
     Bullous Pemphigoid and more than 20 other diseases.


                              Antonio Salafia
Vitamin B6: importance.
• Vitamin B6 is a potent antioxidant.
• Involved in the homeostasis of Glutathione and
    Cysteine (switching mechanism of Ito).
•   In high doses, is capable of transforming
    Glutammic acid into Pyrrolecarboxylic acid and
    prevents the formation of Glutathione (Frati).
•   In my experience, it helps to prevent new
    patches, so I advise my pts. to keep on taking
    for years.
•   (It prevents homocysteine-induced atherosceloris in rats).

                             Antonio Salafia
First experiments with my protocol
          and my lotions.




               Antonio Salafia
Face: Locoid
                  Arms: Lotion B
                  Cure in 6 months.




Antonio Salafia
Lotion 5-F




Antonio Salafia
Dapsone+B6
and Locoid




             Antonio Salafia
Locoid… Lotion A




                   Antonio Salafia
Protocol C + Lotion 5-F.




            Antonio Salafia
Face: Locoid. Neck: Lotion A




             Antonio Salafia
Lotion B




Antonio Salafia
Lotion 5-F. Stopped oral
            medications and relapsed.




Antonio Salafia
Chemical Vitiligo: Lotion A




                 Antonio Salafia
Lt. Lotion B. Rt.Lotion 5-F




              Antonio Salafia
Lotion 5-F




             Antonio Salafia
Results in 8730 (out of 13.119)
• Protocol ‘A’: Vitamins, Iron, Copper; creams: Betnovate/Placenta extract.

• Protocol ‘B’ : Orally as above + Dapsone+ locally Locoid/ Betnovate.

• Protocol ‘C’: Dapsone 0.5 -1.0 mg/k/w + all the Vitamins,
                         Local application
       Children : Locoid for face, Lotion A for body.
       Adults: Face & Neck: Locoid / Lotion A /Tacrolimus.
                  Body:           Lotion B.
                  Limbs:          Lotion 5-F.
•   Protocol ‘D’ : all of these except Dapsone; in its place, oral steroids.
• Given the large number of patients treated, protocol A can be considered as
    ‘control group’ vs. protocol ‘B’ and ‘C’’.
• I cannot due ‘double-blind trials’ in patients who are
    desperate for a cure.
                                      Antonio Salafia
How to read the charts.
•   Worse/Nil = are self-explanatory.
•   Poor      = improvement less than 25%.
•   Fair      = improvement 25% to 50%.
•   Good      = > 50% but < 75%.
•   Excellent = more than 75%.
•   Almost cure = extensive lesions, ‘cured’ except
              for one or two stubborn patches.
•   Cure = total and permanent cure.

                       Antonio Salafia
Protocol A: Vitamins…
               Protocol A – 1673 pts.


700


600


500


400


300


200


100


      0

 CURE     AC    E        G            F   P   N   W



                        Antonio Salafia
Protocol B: Vitamins+DDS
                    Protocol B - 1587 pts.


500


400



300



200


100



  0
      C   AC   EX        G            F      P   N   W

                         Antonio Salafia
Protocol C: DDS+Vitam+My Lotions
                    Protocol C - 4661 pts.

1200


1000


 800


 600


 400


 200


       0
           C   AC   EX      G           F    P   N   W




                           Antonio Salafia
Protocol D:
      Steroids + Vitamins + Lotions
                   Results with Protocol D – 809 pts.


200



150




100



 50



      0
          C   AC        EX      G          F     P      N   W


                               Antonio Salafia
Protocol A – 1673
700
                                                             Protocol C –
600                                         1200             4661
500                                         1000

400                                         800

300                                         600
200                                         400
100                                         200
 0
CURE   AC   E    G   F   P   N    W           0
                                               C        AC     EX    G   F   P   N   W




        Protocol B - 1587
                                                             Protocol D – 809
500
                                               200           pts.
400
                                               150
300

200                                            100

100                                               50

 0                                                 0
  C    AC   EX   G   F   P   N   W                  C    AC     EX   G   F   P   N   W


                                 Antonio Salafia
Results could be better, and lately they are.
Some patients could not follow the therapy because:
- Sunlight not possible: working hours, ladies with lesions
    on chest, thighs; artificial lamps are costly.
- Some patients live far away, even outside India…
- Others changed residence, job, got married…
- Some poor patients could not afford the treatment.
- Others expected miracles.
- Certain areas of the body are ‘difficult’ : fingers, toes,
    bony prominences…..
- Few of them came to rule out ‘Leprosy”.



                           Antonio Salafia
Private Patients from Jan. 2005 to
        Dec. 2008. 2940 pts.
• Protocol C + Inj. Triamcinolone 40 or 20
          mgs. I.M. once a month x 3 - 5.
• Fast results (due to Kenacort) and
• Consistent results (due to Dapsone and B6).
• Patients treated 2940: report on
       ‘regulars’ only: i.e. 2012 cases.


                   Antonio Salafia
Private Patients: Results.

600
500
400
300                                                       1 – 19
200                                                       20 - >

100
 0
      Cure A-cure   Exc   Good     Fair     Nil   Worse


                          Antonio Salafia
Cure Acure Excellent Good Fair               Nil Worse        Total
_________________________________________________________
• Face        427 301           375        175      56      37       0      1371
-----------------------------------------------------------------------------------
• Limbs 523 319                 362        187 110          94      17      1822
-----------------------------------------------------------------------------------
• Hand/
   Feet        71      52        95         104 159 287             31       819
------------------------------------------------------------------------------------
• Body 467 262                   326         24      43     37      16      1175
-----------------------------------------------------------------------------------
• Vagina 58             21        33          17      14     21       0      164
------------------------------------------------------------------------------------
• Penis        15      11         16          30      42     31       5      150


                                    Antonio Salafia
Results, as per area of the body.

800
                                                   Face
700
600                                                Limbs
                                                   (each)
500
                                                   Hands/ Feet
400                                                (each)
300                                                Body

200                                                Vagina
100                                                (mucosa)
                                                   Penis
  0
                                                   (glans)
      Cure   Excellent           Fair      Worse

                         Antonio Salafia
500

 400
                                                      Results as per
 300                                                  body area:
 200                               Face               Face:       1371
 100                                                  Body:       1175
      0
          Cure   Good   Worse
                                                      Limbs:      1822

                                              500
600

500                                           400

400                                           300
300                             Limbs                               Body
                                              200
200
                                              100
100

 0                                                0


                                Antonio Salafia
Results:
300
250
200
             Hand/
             Feet
                           Hands/ Feet: 819
150
                           Vagina:      164
                           Glans Penis: 150
100
 50
     0




60                    50

50                    40

40         Vagi       30
           na
30                                      Penis
                      20
20
                      10
10

0                      0



         Antonio Salafia
Applied Aloe Vera, got Vitiligo.
Protocol C + Tacrolimus 0.1%.




                            Antonio Salafia
Difficult cases
 Lotion A x 1 year.




                  Antonio Salafia
First Locoid, then Lotion A.




              Antonio Salafia
Segmental: lotion A; 6 mth- 1year.




              Antonio Salafia
Arms: lotion 5-F. Face not responding to anything.




                      Antonio Salafia
Good response in majority of patients:
Face: lotion A. Legs: lotion 5-F.




                Antonio Salafia
Protocol C + Lotion A.: 3 months.
 (very irregular patients) 19 months.




                Antonio Salafia
Lotion A: 6 months.




Antonio Salafia
Neck: Lotion A. Arms: Lotion B.




             Antonio Salafia
Father & Mother affected too.




            Antonio Salafia
Protocol C +
                  Tacroz 0.1%:
                   20.08.2009
                   11.12.2009
                   4.04.2011




Antonio Salafia
Lotion A:
- 22.08.2008 -
  19.09.2008
- 5 months.
Duration of Disease
     8 years.




     Antonio Salafia
Lotion 5-F: 4 months.




         Antonio Salafia
Lotion 5-F: 4 months.(very irregular).




                Antonio Salafia
Face: Tacroz … Lotion A
Hands: Lotion 5-F.




              Antonio Salafia
Neck: A. Arms: 5-F, 4-6 months.




             Antonio Salafia
Face:Tacroz.
Arms and Legs:
   Lotio 5-F.




                 Antonio Salafia
Locoid: 6 months.




             Antonio Salafia
Lotion A.




            Antonio Salafia
Neck: Lotion A. Arms: Lotion 5-F.




               Antonio Salafia
Locoid: 5-6 months.
  17 years later.




              Antonio Salafia
Neck: Lotion A.
Legs: Lotion 5-F.




                Antonio Salafia
Tacroz 0.1. Arms: lotion 5-F.




                      Antonio Salafia
Lotion A,
Lotion 5-F.




              Antonio Salafia
Girl: Tacrolimus. CHILD: Vitix: worse, 9.8.2008.
                  Locoid: 27.9.208 cure in 2 months.




                      Antonio Salafia
Lotion A : 2 months.(treatment is going on)




                   Antonio Salafia
Face: Locoid. Neck: Lotion A. After 2 months.
       (Photoes: 20.9.08   18.10.08          15.11.08)




                           Antonio Salafia
Treated elsewhere with only locoid. My
protocol + Locoid for face. Legs: A




                              Antonio Salafia
Face Lotion A, Abdomen Lotion B




              Antonio Salafia
Patient lives in England: 4 months.




               Antonio Salafia
Lotion B:
                       2 months.
                       5 months.




Antonio Salafia
Face:Locoid
Arms: Lotio
      5-F:
6 months.
Disease Ext.
Duration 8 yrs




  Antonio Salafia
Face:Locoid,
Neck:Lotion A
Arms:Lot. B:
     6 months




    Antonio Salafia
Tacroz 0.03%, later on Homeopathy x 2 years…Worse.
Protocol C + Tacroz 0.1%. Photo 12.3.11 16.4.11




                     Antonio Salafia
Latest photos: 18 June of 2011.




              Antonio Salafia
ANA and anti-DNA –ve. Anti-Thyroglobulin +ve.
Photos: 10.9.2010, 13.12.2010, 2.7.2011.
  Dapsone, Tacroz 0.1%, latest: Lotion A.




                   Antonio Salafia
Surgery. Good and bad surgery.




            Antonio Salafia
Surgery done elsewhere by a well-known
           dermatosurgeon.




                 Antonio Salafia
Punch graft by same dermato(surgeon).




               Antonio Salafia
Operated twice with
punch graft.




                      Antonio Salafia
Conclusion:
    Most patients can be cured; but, there are
          difficult cases and difficult areas.
We are still working on it, because our aim is set high..




                        Antonio Salafia
Antonio Salafia
Thanks to you all
            and
a big thanks to the organizers.




            Antonio Salafia

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Vitiligo - my experience of 25 years and 19156 patients by Dr. A.Salafia

  • 1. Vitiligo: my experience of 25 years and 19.156 patients Dr. Antonio Salafia Dermatologist & Head Dept. Reconstructive Surgery. Vimala Dermatological Centre, Mumbai St.Petersburg, Russia. July 7th 2011
  • 2. The experience of a clinician. • In the early 1980’s I was disappointed with PUVA, so I explored other avenues: a) From the year 1980 Dapsone was used at Vimala Dermatological Centre, with some success. b) In 1983 I set a protocol:Dapsone, Vitamin B6 -suggested by C. Frati from IDI,Rome. • In 1985 I began experimenting with new lotions, inspired by the work of Prota. (Protocol C). Antonio Salafia
  • 3. Protocol ‘C’ ORAL THERAPY: • Dapsone: 0.5 mgs K/wt. • Vitamin B6 100-300 mg. a day, Iron, Folic Acid. LOCAL APPLICATION: • Face: Locoid (Hydrocortisone Butyrate) Tacrolimus. • Neck: Lotion A (the mildest). • Body / Arms and Legs: Lotion B (strong). • Arms, Legs, Hands, Feet : Lotion 5 –F (strongest). Antonio Salafia
  • 4. Dapsone: possible mode of action. a) Antioxidant: a. Potent scavenger of free radicals (T. Ryan) b. Decreases H2O2 - as good as Catalase (Wozel). c. Weak inhibitor of prostaglandin synthesis. d. Scavenger of oxidative intermediates, and suppressor of PMN (which produce ROS). B) Decreases the level of Glutathione: skin of vitiligo patients has a higher content of Glutathione. By suppressing Glutathione we favor the formation of Eumelanins instead of Pheomelanins (Ito). C) Possible beneficial effects. DDS is an immunomodulator + suppressor of PMN cells, hence effective in diseases wherein there is dense infiltrate of PMN: Dermatitis Herpetiformis, Subcorneal Pustular Dematosis, Scarring/ Bullous Pemphigoid and more than 20 other diseases. Antonio Salafia
  • 5. Vitamin B6: importance. • Vitamin B6 is a potent antioxidant. • Involved in the homeostasis of Glutathione and Cysteine (switching mechanism of Ito). • In high doses, is capable of transforming Glutammic acid into Pyrrolecarboxylic acid and prevents the formation of Glutathione (Frati). • In my experience, it helps to prevent new patches, so I advise my pts. to keep on taking for years. • (It prevents homocysteine-induced atherosceloris in rats). Antonio Salafia
  • 6. First experiments with my protocol and my lotions. Antonio Salafia
  • 7. Face: Locoid Arms: Lotion B Cure in 6 months. Antonio Salafia
  • 9. Dapsone+B6 and Locoid Antonio Salafia
  • 10. Locoid… Lotion A Antonio Salafia
  • 11. Protocol C + Lotion 5-F. Antonio Salafia
  • 12. Face: Locoid. Neck: Lotion A Antonio Salafia
  • 14. Lotion 5-F. Stopped oral medications and relapsed. Antonio Salafia
  • 15. Chemical Vitiligo: Lotion A Antonio Salafia
  • 16. Lt. Lotion B. Rt.Lotion 5-F Antonio Salafia
  • 17. Lotion 5-F Antonio Salafia
  • 18. Results in 8730 (out of 13.119) • Protocol ‘A’: Vitamins, Iron, Copper; creams: Betnovate/Placenta extract. • Protocol ‘B’ : Orally as above + Dapsone+ locally Locoid/ Betnovate. • Protocol ‘C’: Dapsone 0.5 -1.0 mg/k/w + all the Vitamins, Local application Children : Locoid for face, Lotion A for body. Adults: Face & Neck: Locoid / Lotion A /Tacrolimus. Body: Lotion B. Limbs: Lotion 5-F. • Protocol ‘D’ : all of these except Dapsone; in its place, oral steroids. • Given the large number of patients treated, protocol A can be considered as ‘control group’ vs. protocol ‘B’ and ‘C’’. • I cannot due ‘double-blind trials’ in patients who are desperate for a cure. Antonio Salafia
  • 19. How to read the charts. • Worse/Nil = are self-explanatory. • Poor = improvement less than 25%. • Fair = improvement 25% to 50%. • Good = > 50% but < 75%. • Excellent = more than 75%. • Almost cure = extensive lesions, ‘cured’ except for one or two stubborn patches. • Cure = total and permanent cure. Antonio Salafia
  • 20. Protocol A: Vitamins… Protocol A – 1673 pts. 700 600 500 400 300 200 100 0 CURE AC E G F P N W Antonio Salafia
  • 21. Protocol B: Vitamins+DDS Protocol B - 1587 pts. 500 400 300 200 100 0 C AC EX G F P N W Antonio Salafia
  • 22. Protocol C: DDS+Vitam+My Lotions Protocol C - 4661 pts. 1200 1000 800 600 400 200 0 C AC EX G F P N W Antonio Salafia
  • 23. Protocol D: Steroids + Vitamins + Lotions Results with Protocol D – 809 pts. 200 150 100 50 0 C AC EX G F P N W Antonio Salafia
  • 24. Protocol A – 1673 700 Protocol C – 600 1200 4661 500 1000 400 800 300 600 200 400 100 200 0 CURE AC E G F P N W 0 C AC EX G F P N W Protocol B - 1587 Protocol D – 809 500 200 pts. 400 150 300 200 100 100 50 0 0 C AC EX G F P N W C AC EX G F P N W Antonio Salafia
  • 25. Results could be better, and lately they are. Some patients could not follow the therapy because: - Sunlight not possible: working hours, ladies with lesions on chest, thighs; artificial lamps are costly. - Some patients live far away, even outside India… - Others changed residence, job, got married… - Some poor patients could not afford the treatment. - Others expected miracles. - Certain areas of the body are ‘difficult’ : fingers, toes, bony prominences….. - Few of them came to rule out ‘Leprosy”. Antonio Salafia
  • 26. Private Patients from Jan. 2005 to Dec. 2008. 2940 pts. • Protocol C + Inj. Triamcinolone 40 or 20 mgs. I.M. once a month x 3 - 5. • Fast results (due to Kenacort) and • Consistent results (due to Dapsone and B6). • Patients treated 2940: report on ‘regulars’ only: i.e. 2012 cases. Antonio Salafia
  • 27. Private Patients: Results. 600 500 400 300 1 – 19 200 20 - > 100 0 Cure A-cure Exc Good Fair Nil Worse Antonio Salafia
  • 28. Cure Acure Excellent Good Fair Nil Worse Total _________________________________________________________ • Face 427 301 375 175 56 37 0 1371 ----------------------------------------------------------------------------------- • Limbs 523 319 362 187 110 94 17 1822 ----------------------------------------------------------------------------------- • Hand/ Feet 71 52 95 104 159 287 31 819 ------------------------------------------------------------------------------------ • Body 467 262 326 24 43 37 16 1175 ----------------------------------------------------------------------------------- • Vagina 58 21 33 17 14 21 0 164 ------------------------------------------------------------------------------------ • Penis 15 11 16 30 42 31 5 150 Antonio Salafia
  • 29. Results, as per area of the body. 800 Face 700 600 Limbs (each) 500 Hands/ Feet 400 (each) 300 Body 200 Vagina 100 (mucosa) Penis 0 (glans) Cure Excellent Fair Worse Antonio Salafia
  • 30. 500 400 Results as per 300 body area: 200 Face Face: 1371 100 Body: 1175 0 Cure Good Worse Limbs: 1822 500 600 500 400 400 300 300 Limbs Body 200 200 100 100 0 0 Antonio Salafia
  • 31. Results: 300 250 200 Hand/ Feet Hands/ Feet: 819 150 Vagina: 164 Glans Penis: 150 100 50 0 60 50 50 40 40 Vagi 30 na 30 Penis 20 20 10 10 0 0 Antonio Salafia
  • 32. Applied Aloe Vera, got Vitiligo. Protocol C + Tacrolimus 0.1%. Antonio Salafia
  • 33. Difficult cases Lotion A x 1 year. Antonio Salafia
  • 34. First Locoid, then Lotion A. Antonio Salafia
  • 35. Segmental: lotion A; 6 mth- 1year. Antonio Salafia
  • 36. Arms: lotion 5-F. Face not responding to anything. Antonio Salafia
  • 37. Good response in majority of patients: Face: lotion A. Legs: lotion 5-F. Antonio Salafia
  • 38. Protocol C + Lotion A.: 3 months. (very irregular patients) 19 months. Antonio Salafia
  • 39. Lotion A: 6 months. Antonio Salafia
  • 40. Neck: Lotion A. Arms: Lotion B. Antonio Salafia
  • 41. Father & Mother affected too. Antonio Salafia
  • 42. Protocol C + Tacroz 0.1%: 20.08.2009 11.12.2009 4.04.2011 Antonio Salafia
  • 43. Lotion A: - 22.08.2008 - 19.09.2008 - 5 months. Duration of Disease 8 years. Antonio Salafia
  • 44. Lotion 5-F: 4 months. Antonio Salafia
  • 45. Lotion 5-F: 4 months.(very irregular). Antonio Salafia
  • 46. Face: Tacroz … Lotion A Hands: Lotion 5-F. Antonio Salafia
  • 47. Neck: A. Arms: 5-F, 4-6 months. Antonio Salafia
  • 48. Face:Tacroz. Arms and Legs: Lotio 5-F. Antonio Salafia
  • 49. Locoid: 6 months. Antonio Salafia
  • 50. Lotion A. Antonio Salafia
  • 51. Neck: Lotion A. Arms: Lotion 5-F. Antonio Salafia
  • 52. Locoid: 5-6 months. 17 years later. Antonio Salafia
  • 53. Neck: Lotion A. Legs: Lotion 5-F. Antonio Salafia
  • 54. Tacroz 0.1. Arms: lotion 5-F. Antonio Salafia
  • 55. Lotion A, Lotion 5-F. Antonio Salafia
  • 56. Girl: Tacrolimus. CHILD: Vitix: worse, 9.8.2008. Locoid: 27.9.208 cure in 2 months. Antonio Salafia
  • 57. Lotion A : 2 months.(treatment is going on) Antonio Salafia
  • 58. Face: Locoid. Neck: Lotion A. After 2 months. (Photoes: 20.9.08 18.10.08 15.11.08) Antonio Salafia
  • 59. Treated elsewhere with only locoid. My protocol + Locoid for face. Legs: A Antonio Salafia
  • 60. Face Lotion A, Abdomen Lotion B Antonio Salafia
  • 61. Patient lives in England: 4 months. Antonio Salafia
  • 62. Lotion B: 2 months. 5 months. Antonio Salafia
  • 63. Face:Locoid Arms: Lotio 5-F: 6 months. Disease Ext. Duration 8 yrs Antonio Salafia
  • 64. Face:Locoid, Neck:Lotion A Arms:Lot. B: 6 months Antonio Salafia
  • 65. Tacroz 0.03%, later on Homeopathy x 2 years…Worse. Protocol C + Tacroz 0.1%. Photo 12.3.11 16.4.11 Antonio Salafia
  • 66. Latest photos: 18 June of 2011. Antonio Salafia
  • 67. ANA and anti-DNA –ve. Anti-Thyroglobulin +ve. Photos: 10.9.2010, 13.12.2010, 2.7.2011. Dapsone, Tacroz 0.1%, latest: Lotion A. Antonio Salafia
  • 68. Surgery. Good and bad surgery. Antonio Salafia
  • 69. Surgery done elsewhere by a well-known dermatosurgeon. Antonio Salafia
  • 70. Punch graft by same dermato(surgeon). Antonio Salafia
  • 71. Operated twice with punch graft. Antonio Salafia
  • 72. Conclusion: Most patients can be cured; but, there are difficult cases and difficult areas. We are still working on it, because our aim is set high.. Antonio Salafia
  • 74. Thanks to you all and a big thanks to the organizers. Antonio Salafia