1921
Volume 89, Issue 3
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract.

In this randomized, double-blinded Phase 2 trial, 30 patients with 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 ( = 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%; = 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 cutaneous leishmaniasis.

[open-access] This is an Open Access article distributed under the terms of the American Society of Tropical Medicine and Hygiene's Re-use License which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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References

  1. WHO, 2010. Control of the leishmaniases. Report of a meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22–26 March 2010. WHO Technical Report Series 949. [Google Scholar]
  2. University of Texas Southwestern Medical Center, 2008. Dermatologists Identify North Texas Leishmaniasis Outbreak. New Release DALLAS—September 14, 2007. Available at: http://www.utsouthwestern.edu/utsw/cda/dept353744/files/411952.html. Accessed 15 August 2012. [Google Scholar]
  3. Pehoushek JE, Quinn DM, Crum WP, , 2004. Cutaneous leishmaniasis in soldiers returning from deployment to Iraq. J Am Acad Dermatol 51: S125S128.[Crossref] [Google Scholar]
  4. Bern C, Maguire JH, Alvar J, , 2008. Complexities of assessing the disease burden attributable to leishmaniasis. PLoS Negl Trop Dis 2: e313.[Crossref] [Google Scholar]
  5. Sundar S, Jha TK, Thakur CP, Sinha PK, Bhattacharya SK, , 2007. Injectable paromomycin for visceral leishmaniasis in India. N Engl J Med 356: 25712581.[Crossref] [Google Scholar]
  6. Murray HW, Berman JD, Davies CR, Saravia NG, , 2005. Advances in leishmaniasis. Lancet 366: 15611577.[Crossref] [Google Scholar]
  7. Gonzalez U, Pinart M, Rengifo-Pardo M, Macaya A, Alvar J, Tweed JA, , 2009. Interventions for American cutaneous and mucocutaneous leishmaniasis. Cochrane Database Syst Rev CD004834. [Google Scholar]
  8. Gonzalez U, Pinart M, Reveiz L, Alvar J, , 2008. Interventions for Old World cutaneous leishmaniasis. Cochrane Database Syst Rev CD005067. [Google Scholar]
  9. Grogl M, Schuster BG, Ellis WY, Berman JD, , 1999. Successful topical treatment of murine cutaneous leishmaniasis with a combination of paromomycin (Aminosidine) and gentamicin. J Parasitol 85: 354359.[Crossref] [Google Scholar]
  10. Ben Salah A, Buffet PA, Morizot G, Ben Massoud N, Zâatour A, Ben Alaya N, Haj Hamida NB, El Ahmadi Z, Downs MT, Smith PL, Dellagi K, Grögl M, , 2009. 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: e432.[Crossref] [Google Scholar]
  11. Ben Salah A, Zakraoui H, Zaatour A, Ftaiti A, Zaafouri B, Garraoui A, Olliaro PL, Dellagi K, Ben Ismail R, , 1995. A randomized, placebo-controlled trial in Tunisia treating cutaneous leishmaniasis with paromomycin ointment. Am J Trop Med Hyg 53: 162166. [Google Scholar]
  12. de Brujin MH, Labrada LA, Smyth AJ, Santrich C, Barker DC, , 1993. A comparative study of diagnosis by the polymerase chain reaction and by current clinical methods using biopsies from Colombian patients with suspected leishmaniasis. Trop Med Parasitol 44: 201207. [Google Scholar]
  13. Vergel C, Walker J, Saravia NG, , 2005. Amplification of human DNA by primers targeted to Leishmania kinetoplast DNA and post-genome considerations in the detection of parasites by a polymerase chain reaction. Am J Trop Med Hyg 72: 423429. [Google Scholar]
  14. Reithinger R, Dujardin JC, , 2007. Molecular diagnosis of leishmaniasis: current status and future applications. J Clin Microbiol 45: 2125.[Crossref] [Google Scholar]
  15. Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC, Jr, 2010. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med 17: 5054.[Crossref] [Google Scholar]
  16. Campbell I, , 2007. Chi-squared and Fisher-Irwin tests of two-by-two tables with small sample recommendations. Stat Med 26: 36613675.[Crossref] [Google Scholar]
  17. Lydersen S, Fagerland MW, Laake P, , 2009. Recommended tests for association in 2 × 2 tables. Stat Med 28: 11591175.[Crossref] [Google Scholar]
  18. Daneshvar H, Burchmore R, Hagan P, Phillips RS, , 2009. Leishmania major H-line attenuated under pressure of gentamicin, induces a Th1 response which protects susceptible BALB/c mice against infection with virulent L. major . Parasitology 136: 12431250.[Crossref] [Google Scholar]
  19. Daneshvar H, Hagan P, Phillips RS, , 2003. Leishmania mexicana H-line attenuated under pressure of gentamicin, potentiates a Th1 response and control of cutaneous leishmaniasis in BALB/c mice. Parasite Immunol 25: 589596.[Crossref] [Google Scholar]
  20. Daneshvar H, Molaei MM, Kamiabi H, Burchmore R, Hagan P, Stephen Phillips R, , 2010. Gentamicin-attenuated Leishmania infantum: cellular immunity production and protection of dogs against experimental canine leishmaniasis. Parasite Immunol 32: 722730.[Crossref] [Google Scholar]
  21. Soto J, Fuya P, Herrera R, Berman J, , 1998. Topical paromomycin/methylbenzethonium chloride plus parenteral meglumine antimonate as treatment for American cutaneous leishmaniasis: controlled study. Clin Infect Dis 26: 5658.[Crossref] [Google Scholar]
  22. Arana BA, Mendoza CE, Rizzo NR, Kroeger A, , 2001. Randomized, controlled, double-blind trial of topical treatment of cutaneous leishmaniasis with paromomycin plus methylbenzethonium chloride ointment in Guatemala. Am J Trop Med Hyg 65: 466470. [Google Scholar]
  23. Soto-Mancipe J, Grogl M, Berman JD, , 1993. Evaluation of pentamidine for the treatment of cutaneous leishmaniasis in Colombia. Clin Infect Dis 16: 417425.[Crossref] [Google Scholar]
  24. Velez I, Agudelo S, Hendrickx E, Puerta J, Grogl M, Modabber F, Berman J, , 1997. Inefficacy of allopurinol as monotherapy for Colombian cutaneous leishmaniasis. A randomized, controlled trial. Ann Intern Med 126: 232236.[Crossref] [Google Scholar]
  25. Martinez S, Marr JJ, , 1992. Allopurinol in the treatment of American cutaneous leishmaniasis. N Engl J Med 326: 741744.[Crossref] [Google Scholar]
  26. Lopez-Jaramillo P, Rincon MY, Garcia RG, Silva SY, Smith E, Kampeerapappun P, García C, Smith DJ, López M, Vélez ID, , 2010. A controlled, randomized-blinded clinical trial to assess the efficacy of a nitric oxide releasing patch in the treatment of cutaneous leishmaniasis by Leishmania (V.) panamensis . Am J Trop Med Hyg 83: 97101.[Crossref] [Google Scholar]
  27. Garnier T, Croft SL, , 2002. Topical treatment for cutaneous leishmaniasis. Curr Opin Investig Drugs 3: 538544. [Google Scholar]
  28. El-Sayed M, Anwar AE, , 2009. Intralesional sodium stibogluconate alone or its combination with either intramuscular sodium stibogluconate or oral ketoconazole in the treatment of localized cutaneous leishmaniasis: a comparative study. J Eur Acad Dermatol Venereol 24: 335340.[Crossref] [Google Scholar]
  29. Willard RJ, Jeffcoat AM, Benson PM, Walsh DS, , 2005. Cutaneous leishmaniasis in soldiers from Fort Campbell, Kentucky returning from Operation Iraqi Freedom highlights diagnostic and therapeutic options. J Am Acad Dermatol 52: 977987.[Crossref] [Google Scholar]
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  • Received : 06 Dec 2012
  • Accepted : 06 Apr 2013
  • Published online : 04 Sep 2013

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