title: Topical paromomycin with or without gentamicin for cutaneous leishmaniasis.
abstract: BACKGROUND
  There is a need for a simple and efficacious treatment for cutaneous leishmaniasis with an acceptable side-effect profile.
  
  
  METHODS
  We conducted a randomized, vehicle-controlled phase 3 trial of topical treatments containing 15% paromomycin, with and without 0.5% gentamicin, for cutaneous leishmaniasis caused by Leishmania major in Tunisia. We randomly assigned 375 patients with one to five ulcerative lesions from cutaneous leishmaniasis to receive a cream containing 15% paromomycin-0.5% gentamicin (called WR 279,396), 15% paromomycin alone, or vehicle control (with the same base as the other two creams but containing neither paromomycin nor gentamicin). Each lesion was treated once daily for 20 days. The primary end point was the cure of the index lesion. Cure was defined as at least 50% reduction in the size of the index lesion by 42 days, complete reepithelialization by 98 days, and absence of relapse by the end of the trial (168 days). Any withdrawal from the trial was considered a treatment failure.
  
  
  RESULTS
  The rate of cure of the index lesion was 81% (95% confidence interval [CI], 73 to 87) for paromomycin-gentamicin, 82% (95% CI, 74 to 87) for paromomycin alone, and 58% (95% CI, 50 to 67) for vehicle control (P<0.001 for each treatment group vs. the vehicle-control group). Cure of the index lesion was accompanied by cure of all other lesions except in five patients, one in each of the paromomycin groups and three in the vehicle-control group. Mild-to-moderate application-site reactions were more frequent in the paromomycin groups than in the vehicle-control group.
  
  
  CONCLUSIONS
  This trial provides evidence of the efficacy of paromomycin-gentamicin and paromomycin alone for ulcerative L. major disease. (Funded by the Department of the Army; ClinicalTrials.gov number, NCT00606580.).
authors: Institut Pasteur de Tunis, Tunis, Tunisia.
authors: Afif
authors: A
authors: Ben Salah
authors: Nathalie
authors: N
authors: Ben Messaoud
authors: Evelyn
authors: E
authors: Guedri
authors: Amor
authors: A
authors: Zaatour
authors: Nissaf
authors: N
authors: Ben Alaya
authors: Jihene
authors: J
authors: Bettaieb
authors: Adel
authors: A
authors: Gharbi
authors: Nabil
authors: N
authors: Belhadj Hamida
authors: Aicha
authors: A
authors: Boukthir
authors: Sadok
authors: S
authors: Chlif
authors: Kidar
authors: K
authors: Abdelhamid
authors: Zaher
authors: Z
authors: El Ahmadi
authors: Hechmi
authors: H
authors: Louzir
authors: Mourad
authors: M
authors: Mokni
authors: Gloria
authors: G
authors: Morizot
authors: Pierre
authors: P
authors: Buffet
authors: Philip L
authors: PL
authors: Smith
authors: Karen M
authors: KM
authors: Kopydlowski
authors: Mara
authors: M
authors: Kreishman-Deitrick
authors: Kirsten S
authors: KS
authors: Smith
authors: Carl J
authors: CJ
authors: Nielsen
authors: Diane R
authors: DR
authors: Ullman
authors: Jeanne A
authors: JA
authors: Norwood
authors: George D
authors: GD
authors: Thorne
authors: William F
authors: WF
authors: McCarthy
authors: Ryan C
authors: RC
authors: Adams
authors: Robert M
authors: RM
authors: Rice
authors: Douglas
authors: D
authors: Tang
authors: Jonathan
authors: J
authors: Berman
authors: Janet
authors: J
authors: Ransom
authors: Alan J
authors: AJ
authors: Magill
authors: Max
authors: M
authors: Grogl
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D057194:Intention to Treat Analysis; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010303:Paromomycin / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D005839:Gentamicins; D009824:Ointments; D010303:Paromomycin