BACKGROUND: Narrow-band UVB and topical corticosteroids are treatments for vitiligo. The possible synergistic effect of these modalities has not yet been investigated.
OBJECTIVE: This study aims to compare the efficacy of combining narrow-band UVB (NB-UVB) and 0.05% clobetasol propionate ointment (CP) with that of NB-UVB and placebo in inducing initial and overall repigmentation and control of disease activity after 6 months of therapy. Moreover, it aims to assess the safety and determine the permanence ofrepigmentation within I year post-treatment in both regimens.
METHODS: Randomized, placebo-controlled, double-blind, left-right comparison was conducted on generalized vitiligo patients with 5-50% body surface area involvement, having at least 2 bilateral, comparative lesions. CP or placebo was applied once daily on either side of the body, each combined with NB-UVB thrice weekly for 6 months.
OUTCOME MEASURES: (1) number of exposures and cumulative dose (CD) of NB-UVB that induced initial repigmentation; (2) quantity of repigmentation after 6 months estimated by comparing pre- and post-treatment photographs; (3) effect on disease activity by comparing pre- and post-treatment VIDA (vitiligo disease activity) scores; and (4) permanence of repigmentation and development of new lesions within 1 year post-treatment documented by photographs.
ANALYSIS: Sample size was calculated using formula for testing two proportions at 0.05 level of significance and a power of 0.80. Data was analyzed with Student t test (paired), Exact test for symmetry and Wilcoxon signed rank test, depending on the data set involved.
RESULTS: Twenty-five patients were recruited, but only 20 were evaluable at the end of the study. Initial repigmentation was noted after a mean of 9.30 +/- 3.54 exposures (mean CD 1,887.8 +/- 1195.81 mJ/cm2) of NB-UVB on the CP-treated side, and after a mean of 15.85 +/- 5.61 exposures (mean CD 4,152.2 +/- 2231.9 mJ/cm2) on the placebo side. After 6 months, 55% (11/20) and 40%(8/20) of patients exhibited marked (>75 %) repigmentation in the NB-UVB with CP side, and NB-UVB with placebo side, respectively. Adverse events were minimal and transient. VIDA scores improved and repigmentation induced by both treatment regimens remained stable in majority within one year post-treatment.
CONCLUSIONS: Combination NB-UVB and CP induced repigmentation earlier, requiring significantly lower cumulative dose of NB-UVB than NB-UVB plus placebo. Over all quantity and permanence of repigmentation, as well as control of disease activity and safety, were comparable in the two regimens.