Mehdi Amirnia1, Effat Khodaeiani1, Daniel F Fouladi2, Sima Masoudnia3. 1. b Department of Dermatology , Sina Teaching Hospital, Tabriz University of Medical Sciences , Tabriz , Iran and. 2. c Neurosciences Research Center, Tabriz University of Medical Sciences , Tabriz , Iran. 3. a Drug Applied Research Center, Tabriz University of Medical Sciences , Tabriz , Iran.
Abstract
BACKGROUND: Due to paucity of randomized clinical trials, intralesional immunotherapy has not been yet accepted as a standard therapeutic method. OBJECTIVE: To examine the efficacy 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 eitherintralesional PPD antigen (n = 35) or intralesional saline (n = 34) for six times at 2-week intervals. A third group of candidates for cryotherapy (n = 33) was also included. The decrease in lesion size (good: complete response, intermediate: 50-99% improvement, poor: <50% improvement), adverse effects 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 PPD patients; 0%, 14.7% and 85.3% of the placebo patients and 18.2%, 33.3% and 48.5% of the cryotherapy patients, respectively (PPD versus placebo: p < 0.001; PPD versus cryotherapy: p < 0.001). No significant complication was seen in the PPD group. The recurrence rate was 8.6%, 5.9% and 24.2% in the PPD, placebo and cryotherapy groups, respectively (p > 0.05). CONCLUSION:Intralesional immunotherapy with PPD antigen is highly effective and safe for treating recalcitrant warts. CLINICAL TRIAL REGISTRATION: IRCT201407089844N3 in the Iranian Registry of Clinical Trials (IRCT).
RCT Entities:
BACKGROUND: Due to paucity of randomized clinical trials, intralesional immunotherapy has not been yet accepted as a standard therapeutic method. OBJECTIVE: To examine the efficacy 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 PPD antigen (n = 35) or intralesional saline (n = 34) for six times at 2-week intervals. A third group of candidates for cryotherapy (n = 33) was also included. The decrease in lesion size (good: complete response, intermediate: 50-99% improvement, poor: <50% improvement), adverse effects 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 the cryotherapy patients, respectively (PPD versus placebo: p < 0.001; PPD versus cryotherapy: p < 0.001). No significant complication was seen in the PPD group. The recurrence rate was 8.6%, 5.9% and 24.2% in the PPD, placebo and cryotherapy groups, respectively (p > 0.05). CONCLUSION: Intralesional immunotherapy with PPD antigen is highly effective and safe for treating recalcitrant warts. CLINICAL TRIAL REGISTRATION: IRCT201407089844N3 in the Iranian Registry of Clinical Trials (IRCT).
Entities:
Keywords:
Cryotherapy; recalcitrant; tuberculin purified protein derivative; wart