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Comparison of the topical FK506 and clobetasol propionate as first‐line therapy in the treatment of early alopecia areata

propionate as first-line therapy in the treatment of early alopecia areata Recently, several clinical trials have been performed to assess the efficacy of topical FK506 in treating alopecia areata (AA) on the basis of two successful animal studies which showed that topical FK506 reduced the number of inflammatory cells and induced hair regrowth. Unfortunately, neither of these studies showed any significant effect. However, these disappointing results might be because of unfavorable patient selection such as patients with longstanding AA or the group in which the previous therapy was ineffective. Therefore, we investigated the effect of topical FK506 application as first-line therapy in patients with a previously untreated early mild AA lesion by performing a split trial with topical FK506 (tacrolimus 0.1% ointment, Astrazeneca, London, UK) and clobetasol propionate 0.05% lotion (Galderma, Lausanne, Switzerland). Twelve patients were enrolled in this study. The average size of the alopecic patch was 7.0 9 6.3 cm, and the mean duration of alopecia was 3.5 months. Patients were instructed to apply the two topical agents twice daily for 16 weeks; FK506 on one side of the scalp and clobetasol propionate on the other side of the scalp, after dividing the alopecic patch by two with a 0.5 cm wide free zone between the two areas. They were not allowed to take any other medicines or vitamins during the treatment. After 16 weeks, the more effective agent was applied on the other side of the scalp for an additional 8 weeks to evaluate the effect of the two topical agents once again. The improvement in AA was recorded in five grades when the decreased alopecic area compared to the baseline was calculated. Topical clobetasol propionate induced excellent improvement in four patients (33.3%), good improvement in one patient (8.3%), and moderate improvement in two patients (16.7%) after 16 weeks. On the other hand, topical FK506 induced moderate improvement in only 2 of the 12 patients (16.7%) after 16 weeks (Table 1). On comparing the effect of both topical treatments, clobetasol propionate treatment yielded a better outcome than topical FK506 in 8 of the 12 patients (Fig. 1, Table 1). Four patients, who experienced excellent improvement with clobetasol propionate in the initial part of the trial, applied clobetasol propionate on the other side of the scalp instead of FK506 for an additional 8 weeks. All four patients reported that there was regrowth of hair on the area where topical FK506 was slightly effective (Table 1). AA is a tissue-specific autoimmune disease, and immunosuppressive agents, such as corticosteroids, calcineurin inhibitors, and biologics, are expected to be effective. Although FK506 had an immune-modulating effect, it did not satisfactorily treat AA refractory to steroids or moderate to severe alopecia areata. Price et al. stated that the failure of topical FK506 to stimulate hair growth in AA patients might be because of insufficient penetration of the current ointment formulation and unfavorable patient selection such as patients with longstanding AA or alopecia universalis because the extent and duration of the disease was closely related to the outcome of treatment. Therefore, in the present study, we selected AA patients with less than 6 months of duration who did not