title: Intralesional immunotherapy with tuberculin purified protein derivative (PPD) in recalcitrant wart: A randomized, placebo-controlled, double-blind clinical trial including an extra group of candidates for cryotherapy.
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 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 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).
  
  
  CONCLUSIONS
  Intralesional immunotherapy with PPD antigen is highly effective and safe for treating recalcitrant warts.
  
  
  BACKGROUND
  IRCT201407089844N3 in the Iranian Registry of Clinical Trials (IRCT).
authors: b Department of Dermatology , Sina Teaching Hospital, Tabriz University of Medical Sciences , Tabriz , Iran and.
authors: Mehdi
authors: M
authors: Amirnia
authors: b Department of Dermatology , Sina Teaching Hospital, Tabriz University of Medical Sciences , Tabriz , Iran and.
authors: Effat
authors: E
authors: Khodaeiani
authors: c Neurosciences Research Center, Tabriz University of Medical Sciences , Tabriz , Iran.
authors: Daniel F
authors: DF
authors: Fouladi
authors: a Drug Applied Research Center, Tabriz University of Medical Sciences , Tabriz , Iran.
authors: Sima
authors: S
authors: Masoudnia
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D017679:Cryotherapy / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D014373:Tuberculin / Q000008:administration & dosage*; D014860:Warts / Q000628:therapy*; D055815:Young Adult
chemical_list: D014373:Tuberculin
keywords: Cryotherapy; recalcitrant; tuberculin purified protein derivative; wart