Randomized, double-blinded, phase 2 trial of WR 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis in Panama
- PMID: 23857024
- PMCID: PMC3771300
- DOI: 10.4269/ajtmh.12-0736
Randomized, double-blinded, phase 2 trial of WR 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis in Panama
Abstract
In this randomized, double-blinded Phase 2 trial, 30 patients with Leishmania panamensis 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 (P = 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%; P = 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 L. panamensis cutaneous leishmaniasis.
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Comment in
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Topical paromomycin and gentamicin for new world cutaneous leishmaniasis in Panama.Am J Trop Med Hyg. 2014 Jun;90(6):1191. doi: 10.4269/ajtmh.14-0040a. Am J Trop Med Hyg. 2014. PMID: 24898981 Free PMC article. No abstract available.
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In response.Am J Trop Med Hyg. 2014 Jun;90(6):1192. doi: 10.4269/ajtmh.14-0040b. Am J Trop Med Hyg. 2014. PMID: 24898982 Free PMC article. No abstract available.
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