Abstract
BACKGROUND: Alopecia areata (AA) is an autoimmune disease of the hair follicles. Although some cases resolve spontaneously, many patients require some form of treatment, including corticosteroids and vitamin D analogues, among others. Cytokine signaling in autoimmune disorders and their inhibition have been the prime objective in therapeutic research over the past few years. Janus kinase inhibitors such as tofacitinib have shown efficacy in the treatment of AA. The present study aimed to evaluate the efficacy of a novel formulation of topical tofacitinib compared to vehicle in patients with AA. MATERIALS AND METHODS: A prospective, non-blinded, intrasubject vehicle-controlled study was conducted in patients with AA for a total duration of 6 months. A 2% tofacitinib citrate ointment was compounded in the pharmacy. Tofacitinib tablets (5 mg) were crushed and mixed in white soft paraffin to produce 2% ointment. A thin layer of this ointment was applied to the treatment patch, while the control patches received the application of the vehicle twice daily. Both patches in each patient were evaluated for percentage change in severity of alopecia tool [SALT] score after 24 weeks as the primary outcome. This was graded as excellent response (>50% improvement), intermediate response (25-50%), mild response (5-25%), and no response (<5% improvement). Trichoscopy and hair pull test were evaluated as secondary outcomes. RESULTS: The present study included 30 patients with AA having a median age of 27 years. Among 30 patients, 40% achieved excellent response (>50% change in the SALT score) over six months of treatment. The mean SALT score was significantly reduced from baseline to six months of treatment (mean [95% CI]: 4.3 [1.9-6.3]; P = 0.001). The control patch had substantially higher positive results in the final hair pull test, indicating disease activity (Treatment: 10% vs. Control: 86.7%, P < 0.001). Compared to the control patch, the prevalence of upright hair (10.0% vs. 80.0%) and terminal hair (3.3% vs. 70.0%) were significantly higher in the treatment patch (P < 0.001). No serious adverse effects were reported during the study duration. LIMITATIONS: Sample size was small and the followup was not long enough to study the full effects of tofacitinib, as well as maintenance of remission or relapse after discontinuation. CONCLUSION: Topical tofacitinib proved to be an efficacious and well-tolerated treatment modality for AA with no adverse effects reported during this study.