Comparing the efficacy of topical clobetasol 0.05% plus 5-fluorouracil 5% cream vs. topical clobetasol 0.05% alone in treatment of vitiligo

Vitiligo is an acquired, autoimmune melanocytic disorder characterized by circumscribed depigmented macules and patches. It affects approximately 0.5-2% of the general population worldwide. Many medical treatments have been attempted with partial success, but there has been no previous trial on the combination of topical 5-fluorouracil (5FU) 5% and clobetasol. METHODS: The aim of this study was to evaluate and compare the therapeutic efficacy of topical clobetasol (as a standard method for treatment of vitiligo) versus a combination of topical clobetasol plus 5FU. In this double-blind clinical trial study, 45 patients who had at least two vitiligo patches were treated with topical clobetasol on one side of the body, and with a combination of clobetasol and 5FU on the other side. Treatment was repeated every other day, once a day, for three months. At the end of the treatment, patients were visited again to be evaluated for the therapeutic efficacy of the drugs. RESULTS: Paired t-test revealed a significant improvement in both sides (the right side which was treated with 5-FU+clobetasol and the left side which was treated with clobetasol alone). Therefore, both drugs seem to have been effective in the improvement of vitiligo (p < 0.0001). Comparing the percentage of improvement in the lesion size, there was a statistical difference between the two groups (right side = 38.1 ± 4.3%, left side =24.2 ± 3.3%; p < 0.0001). CONCLUSIONS: Adding topical 5FU to clobetasol increases its efficacy in treatment of vitiligo without significant side effects.