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Research Article

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 equal contributor,

    equal contributor Contributed equally to this work with: Afif Ben Salah, Pierre A. Buffet

    Affiliation: Institut Pasteur de Tunis, Tunis, Tunisia

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  • Pierre A. Buffet equal contributor,

    equal contributor Contributed equally to this work with: Afif Ben Salah, Pierre A. Buffet

    Affiliation: Institut Pasteur, Paris, France

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  • Gloria Morizot,

    Affiliation: Institut Pasteur, Paris, France

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  • Nathalie Ben Massoud,

    Affiliation: Institut Pasteur de Tunis, Tunis, Tunisia

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  • Amor Zâatour,

    Affiliation: Institut Pasteur de Tunis, Tunis, Tunisia

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  • Nissaf Ben Alaya,

    Affiliation: Institut Pasteur de Tunis, Tunis, Tunisia

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  • Nabil Bel Haj Hamida,

    Affiliation: Institut Pasteur de Tunis, Tunis, Tunisia

    X
  • Zaher El Ahmadi,

    Affiliation: Direction Régionale de la Santé de Sidi Bouzid, Sidi Bouzid, Tunisia

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  • Matthew T. Downs,

    Affiliation: Statistics Collaborative, Washington, D.C., United States of America

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  • Philip L. Smith,

    Affiliation: United States Army Medical Materiel Development Activity, Fort Detrick, Maryland, United States of America

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  • Koussay Dellagi,

    Affiliation: Institut Pasteur de Tunis, Tunis, Tunisia

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  • Max Grögl mail

    max.grogl1@us.army.mil

    Affiliation: Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America

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  • Published: May 05, 2009
  • DOI: 10.1371/journal.pntd.0000432

About the Authors

Afif Ben Salah, Nathalie Ben Massoud, Amor Zâatour, Nissaf Ben Alaya, Nabil Bel Haj Hamida, Koussay Dellagi
Institut Pasteur de Tunis, Tunis, Tunisia
Pierre A. Buffet, Gloria Morizot
Institut Pasteur, Paris, France
Zaher El Ahmadi
Direction Régionale de la Santé de Sidi Bouzid, Sidi Bouzid, Tunisia
Matthew T. Downs
Statistics Collaborative, Washington, D.C., United States of America
Philip L. Smith
United States Army Medical Materiel Development Activity, Fort Detrick, Maryland, United States of America
Max Grögl
Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America

Corresponding Author

Email: max.grogl1@us.army.mil

Competing Interests

Patent-Actual: As a member of the US Army, MG received $200 when he signed the patent to the US Army. MG has no financial competing interests and would like to see this product approved by the FDA for the good of the soldiers and people in endemic countries.

Author Contributions

Wrote the paper: PAB. Conceived and designed the study: ABS PAB MG. Implemented the study in Paris: PAB GM. Implemented the study in Tunisia: ABS NBM AZ NBHH ZEA. Implemented cGCP at French and Tunisian sites: ABS PAB GM MG. Coordinated the study sites: PAB GM. Analyzed the data: ABS PAB NBA MTD MG. Wrote the paper: ABS PAB PLS MG. Managed the funding and contracts: GM PLS. Facilitated the study and assisted in the design of the study KD. Overall responsibility for the study: MG.