• 1.

    Sosa N, Capitan Z, Nieto J, Nieto M, Calzada J, Paz H, Spandafora C, Kreisjman-Deitrick M, Kopydlowski K, Ullman D, McCarthy WF, Ranson J, Berman J, Scott C, Grogl M, 2013. Randomized, double-blinded, phase 2 trial of WR 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis in Panama. Am J Trop Med Hyg 89: 557563.

    • Search Google Scholar
    • Export Citation
  • 2.

    Krause G, Kroeger A, 1994. Topical treatment of American cutaneous leishmaniasis with paromomycin and methylbenzethonium chloride: a clinical study under field conditions in Ecuador. Trans R Soc Trop Med Hyg 88: 9294.

    • Search Google Scholar
    • Export Citation
  • 3.

    Armijos RX, Weigel MM, Calvopina M, Mancheno M, Rodriguez R, 2004. Comparison of the effectiveness of two topical paromomycin treatments versus meglumine antimoniate for new world cutaneous leishmaniasis. Acta Trop 91: 153160.

    • Search Google Scholar
    • Export Citation
  • 4.

    Ben Salah A, Ben Messaoud N, Guedri E, Zaatour A, Ben Alaya N, Bettaieb J, Gharbi A, Hamida NB, Boukthir A, Chlif S, Abdelhamid K, El Ahmadi Z, Louzir H, Mokni M, Morizot G, Buffet P, Smith PL, Kopydlowski KM, Kreishman-Deitrick M, Smith SK, Nielsen CJ, Ullman DR, Norwood JA, Thorne GD, McCarthy WF, Adams RC, Rice RM, Tang D, Berman J, Ransom J, Magill AJ, Grogl M, 2013. Topical paromomycin with or without gentamicin for cutaneous leishmaniasis. N Engl J Med 368: 524532.

    • Search Google Scholar
    • Export Citation
  • 5.

    ClinicalTrials.gov, Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama. NCT01790659. Available at: http://clinicaltrials.gov/ct2/show/NCT01790659. Accessed January 16, 2014.

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    • Export Citation
  • 6.

    Blum J, Lockwood DN, Visser L, Harms G, Bailey MS, Caumes E, Clerinx J, van Thiel PP, Morizot G, Hatz C, Buffet P, 2012. Local or systemic treatment for New World cutaneous leishmaniasis? Re-evaluating the evidence for the risk of mucosal leishmaniasis. In Health 4: 153163.

    • Search Google Scholar
    • Export Citation
  • 7.

    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; no. 949. Available at: http://whqlibdoc.who.int/trs/WHO_TRS_949_eng.pdf. Accessed January 16, 2014.

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Topical Paromomycin and Gentamicin for New World Cutaneous Leishmaniasis in Panama

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  • Tropical Medicine & Clinical Parasitology, Infectious Diseases Department, Ramón y Cajal Hospital, Madrid, Spain. E-mails: begomongem@gmail.com and rogelio.lopezvelez@salud.madrid.org

Dear Sir:

We read with interest the clinical trial reported by Sosa and others1 in which topical paromomycin/WR 279,369/gentamicin was compared with paromomycin alone for the treatment of New World cutaneous leishmaniasis (NWCL) caused by Leishmania panamensis. The authors concluded that the combination product may provide greater clinical benefit than paromomycin alone.

The authors stated that paromomycin plus methylbenzethonium chloride (MBCL) ointment has not been evaluated alone against L. panamensis. However, Krause and others2 published a non-randomized study of patients in Ecuador with L. panamensis NWCL, with paromomycin sulphate plus MBCL ointment administrated twice a day for 10 days or once a day for 20 days, compared with untreated patients. Cure rates were 85%, 85%, and 9%, respectively. Moreover Armijos and others3 in 2004 performed a randomized controlled trial in Ecuador in patients with Leishmania guyanensis, Leishmania braziliensis, and Leishmania panamensis NWCL, in which topical paromomycin plus MBCL ointment was compared with topical paromomycin sulphate plus urea, both twice a day for 30 days, compared with meglumine antimoniate for 10 days. The cure rates at 3 months were 79%, 70%, 92%, respectively.

The cure rates in these two studies were similar to those seen by Sosa and others1 with combination therapy (86%). Thus, good cure rates for L. panamensis NWCL can be obtained when paromomycin ointment is combined with other agents. However, this was not shown for Leishmania major old world cutaneous leishmaniasis, where no significant difference in efficacy between paromomycin with or without gentamicin was seen.4

Currently a phase 3, randomized, double-blind trial to determine if WR 279,396 is superior to paromomycin alone for L. panamensis NWCL in Panama is ongoing.5 Taking the previous data into account, probably a third therapeutic regimen based on paromomycin 15% plus MBCL 12% should have been included.

Finally, we would like to mention that Sosa and others1 assert that their entry criteria of < 10 cutaneous lesions and no evidence of systemic dissemination conferred a very low risk for future mucosal infection. However, other authors consider local therapy for NWCL caused by L. braziliensis and L. panamensis unsuitable because of the potential risk of metastasis or secondary mucosal spread, and local therapy is recommended only for patients with ≤ 4–5 lesions.6,7

New clinical trials comparing local treatments for L. panamensis NWCL with long follow-up periods to determine the risk of mucosal dissemination are necessary.

  • 1.

    Sosa N, Capitan Z, Nieto J, Nieto M, Calzada J, Paz H, Spandafora C, Kreisjman-Deitrick M, Kopydlowski K, Ullman D, McCarthy WF, Ranson J, Berman J, Scott C, Grogl M, 2013. Randomized, double-blinded, phase 2 trial of WR 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis in Panama. Am J Trop Med Hyg 89: 557563.

    • Search Google Scholar
    • Export Citation
  • 2.

    Krause G, Kroeger A, 1994. Topical treatment of American cutaneous leishmaniasis with paromomycin and methylbenzethonium chloride: a clinical study under field conditions in Ecuador. Trans R Soc Trop Med Hyg 88: 9294.

    • Search Google Scholar
    • Export Citation
  • 3.

    Armijos RX, Weigel MM, Calvopina M, Mancheno M, Rodriguez R, 2004. Comparison of the effectiveness of two topical paromomycin treatments versus meglumine antimoniate for new world cutaneous leishmaniasis. Acta Trop 91: 153160.

    • Search Google Scholar
    • Export Citation
  • 4.

    Ben Salah A, Ben Messaoud N, Guedri E, Zaatour A, Ben Alaya N, Bettaieb J, Gharbi A, Hamida NB, Boukthir A, Chlif S, Abdelhamid K, El Ahmadi Z, Louzir H, Mokni M, Morizot G, Buffet P, Smith PL, Kopydlowski KM, Kreishman-Deitrick M, Smith SK, Nielsen CJ, Ullman DR, Norwood JA, Thorne GD, McCarthy WF, Adams RC, Rice RM, Tang D, Berman J, Ransom J, Magill AJ, Grogl M, 2013. Topical paromomycin with or without gentamicin for cutaneous leishmaniasis. N Engl J Med 368: 524532.

    • Search Google Scholar
    • Export Citation
  • 5.

    ClinicalTrials.gov, Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama. NCT01790659. Available at: http://clinicaltrials.gov/ct2/show/NCT01790659. Accessed January 16, 2014.

    • Search Google Scholar
    • Export Citation
  • 6.

    Blum J, Lockwood DN, Visser L, Harms G, Bailey MS, Caumes E, Clerinx J, van Thiel PP, Morizot G, Hatz C, Buffet P, 2012. Local or systemic treatment for New World cutaneous leishmaniasis? Re-evaluating the evidence for the risk of mucosal leishmaniasis. In Health 4: 153163.

    • Search Google Scholar
    • Export Citation
  • 7.

    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; no. 949. Available at: http://whqlibdoc.who.int/trs/WHO_TRS_949_eng.pdf. Accessed January 16, 2014.

    • Search Google Scholar
    • Export Citation
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