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Left-Right Comparison Study of the Combination of Fluticasone Propionate and UV-A vs Either Fluticasone Propionate or UV-A Alone for the Long-term Treatment of Vitiligo
Wiete Westerhof, MD, PhD;
Ludmila Nieuweboer-Krobotova, MD;
Paul G. H. Mulder, PhD;
Eltjo J. Glazenburg, MSc
Arch Dermatol. 1999;135:1061-1066.
Objective To compare the efficacy and safety of using a combination of fluticasone propionate (FP) and UV-A with that of either drug used alone in the long-term treatment of vitiligo.
Design Prospective, randomized, controlled, left-right comparison study. Repigmentation was judged by a single dermatologist (L.N.-K.) and skin thickness was scored by a pathologist (using biopsy samples), a dermatologist (L.N.-K.) (visually), and patients (using a standard questionnaire).
Setting Netherlands Institute for Pigmentary Disorders, Amsterdam.
Patients Patients with lesions on arms, legs, and trunk were treated on 2 symmetrical lesions for 9 months with FP alone and a combination of FP and UV-A (FP group) or with UV-A alone and a combination of FP and UV-A (UV-A group). Fluticasone propionate cream was applied once daily at about bedtime, and UV-A (10 J/cm2) exposure was twice a week. Patients attended the clinic at 3-month intervals.
Results One hundred thirty-five patients were included, 96 of whom were evaluable after 9 months. Patients not reaching the end point withdrew because of insufficient repigmentation (n=23), decreased motivation (n=11), or protocol violations (n=5). No patient (irrespective of whether they withdrew) experienced any adverse effects. The FP and UV-A groups were comparable with respect to sex, age, and location of lesions. On average, combination treatment was 3 times more effective than either UV-A or FP treatment alone. In the FP group, no atrophy was seen after 9 months with either treatment. In the UV-A group, a little atrophy was detected twice: as well during UV-A treatment alone as during combination treatment.
Conclusions Combination treatment with FP and UV-A is much more effective in reaching complete repigmentation than are FP and UV-A used alone, but large interindividual differences occur. Fluticasone propionate, UV-A, and a combination of FP and UV-A seem to be safe for long-term treatment of vitiligo.
From the Netherlands Institute for Pigmentary Disorders (Drs Westerhof and Nieuweboer-Krobotova), and Department of Dermatology, Academic Medical Centre (Dr Westerhof), Amsterdam; Department of Epidemiology and Biostatistics, Erasmus University, Rotterdam (Dr Mulder); and Medical Department, Glaxo Wellcome BV, Zeist (Mr Glazenburg), the Netherlands.
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