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



Jalali MHA¹ ; Faghihi A^{2, 3} ; Eshaghi H³ Show Affiliations
Source: Journal of Isfahan Medical School Published:2012

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. © 2012, Isfahan University of Medical Sciences(IUMS). All rights reserved.