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WR279,396, a Third Generation Aminoglycoside Ointment for the Treatment of Leishmania major Cutaneous Leishmaniasis: A Phase 2, Randomized, Double Blind, Placebo Controlled Study

By 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 and Max Grögl

Abstract

Cutaneous leishmaniasis is due to a small parasite (Leishmania) that creates disfiguring sores, and affects more than one million persons (mainly children) each year. Treating lesions with a cream—instead of with injections as currently done—would greatly improve the well-being of affected patients. No cream formulation that would be efficient and would not create important skin irritation has been identified yet. Here, we tested a new cream formulation (WR279,396) containing paromomycin and gentamicin, two members of a well-known family of antibacterial antibiotics (aminoglycosides). Injectable paromomycin is efficient in other forms of the disease (visceral leishmaniasis). This was a carefully monitored study (phase 2) involving mainly children in Tunisia and France. The cream was applied twice a day for 20 days. The proportion of patients treated with the paromomycin-containing cream (active formulation) that cured (94%) was higher than that observed (71%) in patients treated with a cream that did not contain the active product (placebo formulation). Local irritation affected less than one-third of the patients and was usually mild. This new cream formulation was safe and effective in treating cutaneous leishmaniasis, thereby providing a new, simple, easily applicable, and inexpensive treatment for this neglected disease

Topics: Research Article
Publisher: Public Library of Science
OAI identifier: oai:pubmedcentral.nih.gov:2673687
Provided by: PubMed Central
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    Citations

    1. (1994). [Treatment of localized cutaneous leishmaniasis].
    2. (1994). A
    3. (1997). A randomized clinical trial of topical paromomycin versus oral ketoconazole for treating cutaneous leishmaniasis in Turkey.
    4. (1995). A randomized, placebo-controlled trial in Tunisia treating cutaneous leishmaniasis with paromomycin ointment.
    5. (1995). A randomized, placebo-controlled trial of a two-week regimen of aminosidine (paromomycin) ointment for treatment of cutaneous leishmaniasis in Iran.
    6. (1999). Access to essential drugs in poor countries: a lost battle?
    7. (2004). Comparison of the effectiveness of two topical paromomycin treatments versus meglumine antimoniate for New World cutaneous leishmaniasis.
    8. (2003). Current treatment approaches to leishmaniasis.
    9. (1998). Cutaneous leishmaniasis in primary school children in the south-eastern Iranian city of Bam,
    10. (2005). Cutaneous leishmaniasis in the returning traveler.
    11. (1984). Development of topical treatment for cutaneous leishmaniasis caused by Leishmania major in experimental animals.
    12. (2002). Drug development for neglected diseases: a deficient market and a public-health policy failure.
    13. (1995). Epidemiology of the leishmaniases. Dermatol Clin 13: 505–523. Topical Treatment of Cutaneous Leishmaniasis
    14. (1986). Failure of meglumine antimoniate to cure cutaneous lesions due to Leishmania major in Algeria [letter].
    15. (2003). Harandi A
    16. (1992). Human leishmaniases: epidemiology and public health aspects.
    17. (2007). Injectable paromomycin for Visceral leishmaniasis in India.
    18. (1991). Intracellular distribution and activity of antibiotics.
    19. (1984). Numerical cladistics of the phylogeny of the genus Leishmania Ross,
    20. (2007). Optimization of Topical Therapy for Leishmania major Localized Cutaneous Leishmaniasis Using a Reliable C57BL/6 Model. PLoS Negl Trop Dis 1:
    21. (2005). Sadeghinia A
    22. (1999). Successful topical treatment of murine cutaneous leishmaniasis with a combination of paromomycin (Aminosidine) and gentamicin.
    23. (1995). The sensitivity of Leishmania species to aminosidine.
    24. (1987). Therapy in man.
    25. (2002). Topical treatment for cutaneous leishmaniasis.
    26. (1986). Topical treatment of cutaneous leishmaniasis.
    27. (1992). Topical treatment of Old World cutaneous leishmaniasis caused by Leishmania major: a double-blind control study.
    28. (2004). Treatment of cutaneous leishmaniasis among travellers.
    29. (2002). Treatment of cutaneous leishmaniasis with a topical antileishmanial drug (WR279396): phase 2 pilot study.
    30. (2002). Visceral leishmaniasis: current status of control, diagnosis, and treatment, and a proposed research and development agenda.

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