title: Intralesional antimony for single lesions of bolivian cutaneous leishmaniasis.
abstract: BACKGROUND
  Cutaneous leishmaniasis is an ultimately self-curing disease for which systemic therapy with pentavalent antimony (Sb) is effective but with side effects. We evaluated 2 local treatments, intralesional (IL) Sb and cryotherapy, for single lesions due to Bolivian Leishmania (v.) braziliensis in a placebo-controlled study.
  
  
  METHODS
  Patients were randomized between IL Sb (650 µg/mm(2) of lesion area on days 1, 3, and 5), cryotherapy (days 1 and 14), and placebo cream (daily for 20 days) in a 3:2:3 allocation. Lesion area was measured prior to therapy, and at 1, 3, and 6 months after therapy. The criteria for lesion cure were as follows: not doubling in size at 1 month, at least 50% diminution in size at 3 months, and complete reepithelialization at 6 months. Local adverse effects were recorded.
  
  
  RESULTS
  Cure rates were 21 of 30 (70%; 95% confidence interval [CI], 52%-83%) for IL Sb, 4 of 20 (20%; 95% CI, 8%-42%) for cryotherapy, and 5 of 30 (17%; 95% CI, 7%-34%) for placebo cream (P < .001 for IL Sb vs each other group). IL Sb adverse events were limited to injection site pain, with a mean value of 1.0 (mild).
  
  
  CONCLUSIONS
  The comparative cure rate, small amount of drug administered, and tolerance data for IL Sb suggest that if local therapy for single L. braziliensis lesions is chosen, this treatment is attractive. Given the difficulties of performing placebo-controlled trials in the New World, the combined placebo and cryotherapy cure rate (18%; 95% CI, 10%-31%) is likely to become the standard against which future interventions for L. braziliensis are compared.
  
  
  BACKGROUND
  NCT01300975.
authors: FUNDERMA (Fundación Nacional de Dermatología), Santa Cruz, Bolivia. jaime.soto@infoleis.com
authors: Jaime
authors: J
authors: Soto
authors: Ernesto
authors: E
authors: Rojas
authors: Miguel
authors: M
authors: Guzman
authors: Aleida
authors: A
authors: Verduguez
authors: Winne
authors: W
authors: Nena
authors: Maria
authors: M
authors: Maldonado
authors: Mary
authors: M
authors: Cruz
authors: Lineth
authors: L
authors: Gracia
authors: Darsi
authors: D
authors: Villarroel
authors: Isidoro
authors: I
authors: Alavi
authors: Julia
authors: J
authors: Toledo
authors: Jonathan
authors: J
authors: Berman
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000965:Antimony / Q000008:administration & dosage* / Q000009:adverse effects; D000981:Antiprotozoal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001838:Bolivia; D002648:Child; D017679:Cryotherapy; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007892:Leishmania braziliensis / Q000187:drug effects / Q000302:isolation & purification; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy* / Q000469:parasitology / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000981:Antiprotozoal Agents; D010919:Placebos; D000965:Antimony