title: Randomized, double-blinded, phase 2 trial of WR 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis in Panama.
abstract: In this randomized, double-blinded Phase 2 trial, 30 patients with Leishmania panamensis cutaneous leishmaniasis were randomly allocated (1:1) to receive once daily topical treatment with WR 279,396 (15% paromomycin + 0.5% gentamicin) or Paromomycin Alone (15% paromomycin) for 20 days. The index lesion cure rate after 6 months follow-up was 13 of 15 (87%) for WR 279,396 and 9 of 15 (60%) for Paromomycin Alone (P = 0.099). When all treated lesions were included, the final cure rate for WR 279,398-treated patients was again 87%, but the final cure rate for Paromomycin Alone-treated patients was 8 of 15 (53.3%; P = 0.046). Both creams were well tolerated with mild application site reactions being the most frequent adverse event. The increased final cure rate in the WR 279,396 group in this small Phase 2 study suggests that the combination product may provide greater clinical benefit than paromomycin monotherapy against L. panamensis cutaneous leishmaniasis.
authors.forename: Néstor
authors.initials: N
authors.lastname: Sosa
authors.forename: Zeuz
authors.initials: Z
authors.lastname: Capitán
authors.forename: Javier
authors.initials: J
authors.lastname: Nieto
authors.forename: Melissa
authors.initials: M
authors.lastname: Nieto
authors.forename: José
authors.initials: J
authors.lastname: Calzada
authors.forename: Hector
authors.initials: H
authors.lastname: Paz
authors.forename: Carmenza
authors.initials: C
authors.lastname: Spadafora
authors.forename: Mara
authors.initials: M
authors.lastname: Kreishman-Deitrick
authors.forename: Karen
authors.initials: K
authors.lastname: Kopydlowski
authors.forename: Diane
authors.initials: D
authors.lastname: Ullman
authors.forename: William F
authors.initials: WF
authors.lastname: McCarthy
authors.forename: Janet
authors.initials: J
authors.lastname: Ransom
authors.forename: Jonathan
authors.initials: J
authors.lastname: Berman
authors.forename: Charles
authors.initials: C
authors.lastname: Scott
authors.forename: Max
authors.initials: M
authors.lastname: Grogl
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage*; D006801:Humans; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D008297:Male; D010176:Panama; D010303:Paromomycin / Q000008:administration & dosage*
chemical_list: D005839:Gentamicins; D010303:Paromomycin