WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study.
PLoS Negl Trop Dis
; 3(5): e432, 2009.
Article
en En
| MEDLINE
| ID: mdl-19415122
ABSTRACT
BACKGROUND:
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.METHODS:
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.RESULTS:
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.CONCLUSION:
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. TRIAL REGISTRATION ClinicalTrials.gov NCT00703924.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Pomadas
/
Tripanocidas
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Leishmaniasis Cutánea
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Leishmania major
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Aminoglicósidos
Tipo de estudio:
Clinical_trials
/
Guideline
Límite:
Adolescent
/
Adult
/
Aged
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Child
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Child, preschool
/
Humans
/
Middle aged
País/Región como asunto:
Africa
/
Europa
Idioma:
En
Revista:
PLoS Negl Trop Dis
Asunto de la revista:
MEDICINA TROPICAL
Año:
2009
Tipo del documento:
Article
País de afiliación:
Túnez