Tuberculin as Intralesional Therapy for Viral Warts—Single-Blind, Split, Placebo, Controlled Study

Abstract

Background: BCG vaccine as an antigen has proved its effectiveness as an immunotherapy for viral warts. Tuberculin is an antigenic extract of M. tuberculosis capable of eliciting an immunological skin reaction. Objective: To assess the efficacy of tuberculin intralesional injection in the treatment of viral warts. Patients and Methods: This single ,blind, placebo controlled study was conducted at the Department of Dermatology, Baghdad Teaching Hospital, Baghdad, Iraq from March 2010 to July 2011.Forty-one patients with different types of viral warts were enrolled in this study; tuberculin test was done to patients prior to instillation of intralesional treatment. Then the patients treated by intralesional tuberculin in each lesion located on the right side of the body, and intralesional distilled water in each lesion located on the left side of to a maximum of 3 injections, at 2 weeks interval or until full resolution of these lesions. Patients were evaluated every 2 weeks to assess the regression of their lesions and to record any local and systemic adverse effects. The response to treatment was evaluated by decrease in size and reduction in number of warts. Scoring of response to treatment was as follow: 1) Responders: including patients who showed complete cure or those with good response (>50% reduction). 2) Non responders: including patients who showed minimal response (<50% reduction), or those with no improvement (stable disease and disease progression). The follow up period lasted up to 2 months after the last dose. Results: Thirty out of 41 patients had completed the study, of them 14 (46.66%) patients showed response of their lesions on the right side of the body that were treated with tuberculin; 15 patients showed no response, 1 patient showed minimal response, 7 patients showed good response and 7 patients showed complete cure (23.33%). Regarding the lesions treated with intralesional distilled water, 25 patients showed no response, 3 patients showed minimal response, 2(6.66) patients showed good response and no patient showed complete cure of their warts. Of the 14 responder patients to intralesional tuberculin, 10 patients were tuberculin tested positive, and 4 patients were tested negative, and of the 16 non responder patients to intralesional tuberculin, 3 patients were tuberculin tested positive, and 13 patients were tuberculin tested negative which was statistically significant difference. No side effects reported from tuberculin therapy apart from mild pain at site of injection. Conclusion: Intralesional injection of tuberculin is an effective therapy for viral warts when compared with control, possibly through its local immunological action and had no systemic immunological response. Patients with previous BCG vaccine showed better response to tuberculin injection.