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

Antonio Salafia

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.

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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).

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First experiments with my protocol and my lotions.

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

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Lotion 5-F

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Dapsone+B6 and Locoid

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Locoid… Lotion A

Protocol C + Lotion 5-F.

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Face: Locoid. Neck: Lotion A

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Lotion B

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Lotion 5-F. Stopped oral

medications and relapsed.

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Chemical Vitiligo: Lotion A

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Lt. Lotion B. Rt.Lotion 5-F

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Lotion 5-F

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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.

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• 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.

How to read the charts.

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Protocol A: Vitamins…

0

100

200

300

400

500

600

700

CURE AC E G F P N W

Protocol A – 1673 pts.

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Protocol B: Vitamins+DDS

0

100

200

300

400

500

C AC EX G F P N W

Protocol B - 1587 pts.

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Protocol C: DDS+Vitam+My Lotions

0

200

400

600

800

1000

1200

C AC EX G F P N W

Protocol C - 4661 pts.

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Protocol D: Steroids + Vitamins + Lotions

0

50

100

150

200

C AC EX G F P N W

Results with Protocol D – 809 pts.

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0

50

100

150

200

C AC EX G F P N W

Protocol D – 809

pts.

0

200

400

600

800

1000

1200

C AC EX G F P N W

Protocol C –

4661

0

100

200

300

400

500

C AC EX G F P N W

Protocol B - 1587

0

100

200

300

400

500

600

700

CURE AC E G F P N W

Protocol A – 1673

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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”.

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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.

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Private Patients: Results.

0

100

200

300

400

500

600

Cure A-cure Exc Good Fair Nil Worse

1 – 19

20 - >

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Cure Acure Excellent Good Fair Nil Worse Total

_________________________________________________________

• Face 427 301 375 175 56 37 0 1371

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• Limbs 523 319 362 187 110 94 17 1822

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• Hand/

Feet 71 52 95 104 159 287 31 819

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• Body 467 262 326 24 43 37 16 1175

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• Vagina 58 21 33 17 14 21 0 164

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• Penis 15 11 16 30 42 31 5 150

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Results, as per area of the body.

0

100

200

300

400

500

600

700

800

Cure Excellent Fair Worse

Face

Limbs

(each)

Hands/ Feet

(each)

Body

Vagina

(mucosa)

Penis

(glans)

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Results as per body area: Face: 1371 Body: 1175 Limbs: 1822 0

100

200

300

400

500

Cure Good Worse

Face

0

100

200

300

400

500

600

Limbs

0

100

200

300

400

500

Body

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Results: Hands/ Feet: 819 Vagina: 164 Glans Penis: 150

0

50

100

150

200

250

300

Hand/

Feet

0

10

20

30

40

50

60

Vagi

na

0

10

20

30

40

50

Penis

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Applied Aloe Vera, got Vitiligo.

Protocol C + Tacrolimus 0.1%.

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Difficult cases Lotion A x 1 year.

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First Locoid, then Lotion A.

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Segmental: lotion A; 6 mth- 1year.

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

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Good response in majority of patients:

Face: lotion A. Legs: lotion 5-F.

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

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Lotion A: 6 months.

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Neck: Lotion A. Arms: Lotion B.

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Father & Mother affected too.

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Protocol C + Tacroz 0.1%: 20.08.2009 11.12.2009

4.04.2011

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

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Lotion 5-F: 4 months.

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

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

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

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

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Locoid: 6 months.

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Lotion A.

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

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Locoid: 5-6 months. 17 years later.

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

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Tacroz 0.1. Arms: lotion 5-F.

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Lotion A, Lotion 5-F.

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

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

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

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

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Face Lotion A, Abdomen Lotion B

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Patient lives in England: 4 months.

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Lotion B: 2 months. 5 months.

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Face:Locoid Arms: Lotio 5-F:

6 months. Disease Ext. Duration 8 yrs

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

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

Latest photos: 18 June of 2011.

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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.

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Surgery. Good and bad surgery.

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Surgery done elsewhere by a well-known dermatosurgeon.

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Punch graft by same dermato(surgeon).

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Operated twice with punch graft.

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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..

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Thanks to you all and

a big thanks to the organizers.

Antonio Salafia