| AbstractBackground: Due to paucity of randomized clinical trials, intralesional immunotherapyhas not been yet accepted as a standard therapeutic method.Objective: To examine theefficacy and safety of intralesional immunotherapy with tuberculin purified protein derivative(PPD) for treating recalcitrant wart.Methods: In this randomized, placebo-controlled, double-blind clinical trial, a total of 69 patients with recalcitrant warts received either intralesional PPDantigen (n¼35) or intralesional saline (n¼34) for six times at 2-week intervals. A third group ofcandidates for cryotherapy (n¼33) was also included. The decrease in lesion size (good:complete response, intermediate: 50–99% improvement, poor:550% improvement), adverseeffects and recurrence within 6-month follow-up were documented.Results:At the final session,good, intermediate and poor responses were observed in 77.1%, 22.9% and 0% of the PPDpatients; 0%, 14.7% and 85.3% of the placebo patients and 18.2%, 33.3% and 48.5% of thecryotherapy patients, respectively (PPD versus placebo:p50.001; PPD versus cryotherapy:p50.001). No significant complication was seen in the PPD group. The recurrence rate was8.6%, 5.9% and 24.2% in the PPD, placebo and cryotherapy groups, respectively (p40.05).Conclusion: Intralesional immunotherapy with PPD antigen is highly effective and safe fortreating recalcitrant warts.Clinical trial registration: IRCT201407089844N3 in the Iranian Registryof Clinical Trials (IRCT). |