WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study.
Cutaneous leishmaniasis (cl) is a disfiguring disease that confronts clinicians with a quandary: leave patients untreated or engage in a complex or toxic treatment. Topical treatment of CL offers a practical and safe option. Accordingly, the treatment of CL with WR279,396, a formulation of paromomyc...
Published in: | PLoS Neglected Tropical Diseases |
---|---|
Main Authors: | , , , , , , , , , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
Public Library of Science (PLoS)
2009
|
Subjects: | |
Online Access: | https://doi.org/10.1371/journal.pntd.0000432 https://doaj.org/article/9a7b46e9e7c541809bcf7eb1648c5129 |
id |
ftdoajarticles:oai:doaj.org/article:9a7b46e9e7c541809bcf7eb1648c5129 |
---|---|
record_format |
openpolar |
spelling |
ftdoajarticles:oai:doaj.org/article:9a7b46e9e7c541809bcf7eb1648c5129 2023-05-15T15:13:02+02:00 WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. Afif Ben Salah Pierre A Buffet Gloria Morizot Nathalie Ben Massoud Amor Zâatour Nissaf Ben Alaya Nabil Bel Haj Hamida Zaher El Ahmadi Matthew T Downs Philip L Smith Koussay Dellagi Max Grögl 2009-01-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0000432 https://doaj.org/article/9a7b46e9e7c541809bcf7eb1648c5129 EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC2673687?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0000432 https://doaj.org/article/9a7b46e9e7c541809bcf7eb1648c5129 PLoS Neglected Tropical Diseases, Vol 3, Iss 5, p e432 (2009) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2009 ftdoajarticles https://doi.org/10.1371/journal.pntd.0000432 2022-12-31T13:43:44Z Cutaneous leishmaniasis (cl) is a disfiguring disease that confronts clinicians with a quandary: leave patients untreated or engage in a complex or toxic treatment. Topical treatment of CL offers a practical and safe option. Accordingly, the treatment of CL with WR279,396, a formulation of paromomycin and gentamicin in a hydrophilic base, was investigated in a phase 2 clinical study in Tunisia and France.A phase 2, randomized, double blind, vehicle-controlled study was conducted to assess the safety and efficacy of topical WR279,396 when applied twice a day for 20 days as treatment for parasitologically confirmed CL. The study protocol established the primary efficacy end point as complete clinical response (CCR) defined as 50% or greater reduction in the ulceration size of an index lesion by day 50 (D50) followed by complete re-epithelialization by D100, and no relapse through D180.Ninety-two subjects were randomized. Leishmania major was identified in 66 of 68 isolates typed (97%). In the intent-to-treat population, 47 of 50 WR279,396 treated participants (94%) met the definition of CCR, compared with 30 of 42 vehicle-placebo participants (71%) [p = 0.0045]. Erythema occurred in 30% and 24% of participants receiving WR279,396 and placebo, respectively [p = 0.64]. There was no clinical or laboratory evidence of systemic toxicity.Application of WR279,396 for 20 days was found to be safe and effective in treating L. major CL, and offers great potential as a new, simple, easily applicable, and inexpensive topical therapy for this neglected disease.ClinicalTrials.gov NCT00703924. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Quandary ENVELOPE(-61.580,-61.580,-64.864,-64.864) PLoS Neglected Tropical Diseases 3 5 e432 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Afif Ben Salah Pierre A Buffet Gloria Morizot Nathalie Ben Massoud Amor Zâatour Nissaf Ben Alaya Nabil Bel Haj Hamida Zaher El Ahmadi Matthew T Downs Philip L Smith Koussay Dellagi Max Grögl WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Cutaneous leishmaniasis (cl) is a disfiguring disease that confronts clinicians with a quandary: leave patients untreated or engage in a complex or toxic treatment. Topical treatment of CL offers a practical and safe option. Accordingly, the treatment of CL with WR279,396, a formulation of paromomycin and gentamicin in a hydrophilic base, was investigated in a phase 2 clinical study in Tunisia and France.A phase 2, randomized, double blind, vehicle-controlled study was conducted to assess the safety and efficacy of topical WR279,396 when applied twice a day for 20 days as treatment for parasitologically confirmed CL. The study protocol established the primary efficacy end point as complete clinical response (CCR) defined as 50% or greater reduction in the ulceration size of an index lesion by day 50 (D50) followed by complete re-epithelialization by D100, and no relapse through D180.Ninety-two subjects were randomized. Leishmania major was identified in 66 of 68 isolates typed (97%). In the intent-to-treat population, 47 of 50 WR279,396 treated participants (94%) met the definition of CCR, compared with 30 of 42 vehicle-placebo participants (71%) [p = 0.0045]. Erythema occurred in 30% and 24% of participants receiving WR279,396 and placebo, respectively [p = 0.64]. There was no clinical or laboratory evidence of systemic toxicity.Application of WR279,396 for 20 days was found to be safe and effective in treating L. major CL, and offers great potential as a new, simple, easily applicable, and inexpensive topical therapy for this neglected disease.ClinicalTrials.gov NCT00703924. |
format |
Article in Journal/Newspaper |
author |
Afif Ben Salah Pierre A Buffet Gloria Morizot Nathalie Ben Massoud Amor Zâatour Nissaf Ben Alaya Nabil Bel Haj Hamida Zaher El Ahmadi Matthew T Downs Philip L Smith Koussay Dellagi Max Grögl |
author_facet |
Afif Ben Salah Pierre A Buffet Gloria Morizot Nathalie Ben Massoud Amor Zâatour Nissaf Ben Alaya Nabil Bel Haj Hamida Zaher El Ahmadi Matthew T Downs Philip L Smith Koussay Dellagi Max Grögl |
author_sort |
Afif Ben Salah |
title |
WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. |
title_short |
WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. |
title_full |
WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. |
title_fullStr |
WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. |
title_full_unstemmed |
WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. |
title_sort |
wr279,396, a third generation aminoglycoside ointment for the treatment of leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2009 |
url |
https://doi.org/10.1371/journal.pntd.0000432 https://doaj.org/article/9a7b46e9e7c541809bcf7eb1648c5129 |
long_lat |
ENVELOPE(-61.580,-61.580,-64.864,-64.864) |
geographic |
Arctic Quandary |
geographic_facet |
Arctic Quandary |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 3, Iss 5, p e432 (2009) |
op_relation |
http://europepmc.org/articles/PMC2673687?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0000432 https://doaj.org/article/9a7b46e9e7c541809bcf7eb1648c5129 |
op_doi |
https://doi.org/10.1371/journal.pntd.0000432 |
container_title |
PLoS Neglected Tropical Diseases |
container_volume |
3 |
container_issue |
5 |
container_start_page |
e432 |
_version_ |
1766343646071750656 |