A Placebo-controlled Comparative Study of Topical Flocinolone Acetonide Ointment versus Topical 0.1% Tacrolimus Ointment in the Treatment of vitiligo Lesions of Upper Extremities

Document Type : Original Article(s)

Authors

1 Associate Professor, Skin and Stem Cell Research Center And Department of Dermatology, Hazrat Rasoul Akram Hospital, Tehran University of Medical Sciences, Tehran, Iran

2 Resident, Skin Disease and Leishmaniasis Research Center And Student Research committee, Isfahan University of Medical Sciences, Isfahan And Department of Dermatology, Hazrat Rasoul Akram Hospital, Tehran University of Medical Sciences, Tehran ,Iran

3 Resident Department of Dermatology, Hazrat Rasoul Akram Hospital, Tehran University of Medical Sciences, Tehran ,Iran

Abstract

Background: Topical flocinolone acetonide and tacrolimus have been used to treat vitiligo for a long time, but there is not enough data available to conduct management decision for these patients. Tacrolimus and corticosteroid have been used for head and neck lesions successfully, and have been accepted as standard treatment. The present study is designed to compare the therapeutic effects of flocinolone acetonide and tacrolimus with each other and with the placebo in the treatment of vitiligo lesions of upper extremities.Methods: The current study was carried out on 28 patients of 16-53 years of age with 150 depigmented lesions of upper extremities. The lesions ranged from 3 to 6 cm. 50 lesions were treated with flocinolone acetonide in isopropyl alcohol (50 grams in 50 cc), 50 lesions with tacrolimus, and 50 control lesions with placebo. Patients were followed for 6 months and visited at 2, 4 and 6 months. Disease response was evaluated by approach of clinical criteria. We considered complete or partial repigmentation as the most important clinical criteria. No systemic treatment or phototherapy was used in this study. Moreover, patients were assessed for any possible drug side- effects. Standard photography was applied in order to follow any changes in lesions. The repigmentation achieved for each group and at each follow-up visit were analyzed and compared to the other groups.Findings: The response rate for the tacrolimus group was: 5 lesions showed complete response, 10 lesions showed partial repigmentation, 3 patches worsened, and 32 showed no alteration. In the flocinolone group 8 lesions had complete response, 24 lesions showed repigmentation, 3 lesions showed partial repigmentation, 3 lesions worsened, and 40 lesions showed no alteration. In the placebo group 1 lesion showed complete response, 3 showed partial response, 6 lesions worsened, and 40 showed no alteration. In our study the response rate of both flocinolone acetonide and tacrolimus groups showed a significant difference to the placebo group (P = 0.049 and P = 0.034, respectively), but no significant difference was observed between the two groups (P = 0.67).Conclusion: Topical flocinolone acetonide and tacrolimus showed no significant differences in the treatment of vitiligo Lesions; therefore, further studies are needed for treatment guidelines.

Keywords

References

  1. Braun-Falco O. Dermatology. 2nd ed. Berlin, Germany: Springer; 2000.
  2. Ortonne JP. Vitiligo and other disorders of hypopigmentation. In: Bolognia J, Rapini RP, Jorizzo JL, editors. Dermatology. New York, NY: Mosby; 2003. p. 947-54.
  3. Mosher DB, Fitzpatrick TB, Ortonne JP. Hypomelanoses and hypermelanoses. In: Freedberg IM, Eisen AZ, Wolff K, Austen KF, Goldsmith LA, Katz SI, et al, editors. Fitzpatrick's dermatology in general medicine. 5th ed. New York, NY,: Mcgraw-Hill; 1999. p. 954-60.
  4. Grimes PE, Morris R, Avaniss-Aghajani E, Soriano T, Meraz M, Metzger A. Topical tacrolimus therapy for vitiligo: therapeutic responses and skin messenger RNA expression of proinflammatory cytokines. J Am Acad Dermatol 2004; 51(1): 52-61.
  5. Al Abadie MS, Senior HJ, Bleehen SS, Gawkrodger DJ. Neuropeptide and neuronal marker studies in vitiligo. Br J Dermatol 1994; 131(2): 160-5.
  6. Bystryn JC. Immune mechanisms in vitiligo. Clin Dermatol 1997; 15(6): 853-61.
  7. Lerner AB. On the etiology of vitiligo and gray hair. Am J Med 1971; 51(2): 141-7.
  8. Silverberg NB, Lin P, Travis L, Farley-Li J, Mancini AJ, Wagner AM, et al. Tacrolimus ointment promotes repigmentation of vitiligo in children: a review of 57 cases. J Am Acad Dermatol 2004; 51(5): 760-6.
  9. Halder RM, Grimes PE, Cowan CA, Enterline JA, Chakrabarti SG, Kenney JA, Jr. Childhood vitiligo. J Am Acad Dermatol 1987; 16(5 Pt 1): 948-54.
  10. Sehgal VN, Srivastava G, Dogra S. Tacrolimus: approved and unapproved dermatologic indications/uses-physician's sequential literature survey: part II. Skinmed 2008; 7(2): 73-7.
  11. Nogueira LS, Zancanaro PC, Azambuja RD. Vitiligo and emotions. An Bras Dermatol 2009; 84(1): 41-5.
  12. Satish DA, Walia A. Epidemiology and etiopathogenesis. In: Saraf V, Fernandez R, Sarangi K, editors. Vitiligo, a monograph and color atlas. 1st ed. Mumbai, India: Fulford (India) Limited; 2000. p. 18-22.
  13. Song MS, Hann SK, Ahn PS, Im S, Park YK. Clinical study of vitiligo: Comparative study of type A and type B vitiligo. Ann Dermatol 1994; 6: 22-30.
  14. Passeron T, Ortonne JP. Physiopathology and genetics of vitiligo. J Autoimmun 2005; 25(Suppl): 63-8.
  15. Lepe V, Moncada B, Castanedo-Cazares JP, Torres-Alvarez MB, Ortiz CA, Torres-Rubalcava AB. A double-blind randomized trial of 0.1% tacrolimus vs 0.05% clobetasol for the treatment of childhood vitiligo. Arch Dermatol 2003; 139(5): 581-5.
  16. Kose O, Arca E, Kurumlu Z. Mometasone cream versus pimecrolimus cream for the treatment of childhood localized vitiligo. J Dermatolog Treat 2010; 21(3): 133-9.
  17. Coskun B, Saral Y, Turgut D. Topical 0.05% clobetasol propionate versus 1% pimecrolimus ointment in vitiligo. Eur J Dermatol 2005; 15(2): 88-91.
Journal of Isfahan Medical School
Volume 29, Issue 173 - Serial Number 173
November and December 2012
Pages 2990-2995

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History

  • Receive Date: 12 March 2012
  • Revise Date: 29 April 2024
  • Accept Date: 06 April 2022

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