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Am. J. Trop. Med. Hyg. · Sep 2013
Randomized Controlled TrialRandomized, double-blinded, phase 2 trial of WR 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis in Panama.
- Néstor Sosa, Zeuz Capitán, Javier Nieto, Melissa Nieto, José Calzada, Hector Paz, Carmenza Spadafora, Mara Kreishman-Deitrick, Karen Kopydlowski, Diane Ullman, William F McCarthy, Janet Ransom, Jonathan Berman, Charles Scott, and Max Grogl.
- Instituto Conmemorativo Gorgas de Estudios de la Salud, Avenida Justo Arosemena, Panama City, Panama. drnososa@gmail.com
- Am. J. Trop. Med. Hyg. 2013 Sep 1; 89 (3): 557-63.
AbstractIn 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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