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Dual-mode Imaging of Cutaneous Tissue Oxygenation and Vascular Function
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Topical paromomycin for New World cutaneous leishmaniasis.

Néstor Sosa1, Juan Miguel Pascale1, Ana I Jiménez1

  • 1Instituto Conmemorativo Gorgas de Estudios de la Salud, Avenida Justo Arosemena, Panama City, Panama.

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Topical paromomycin-gentamicin and paromomycin alone creams showed similar ~80% cure rates for cutaneous leishmaniasis (CL) in Panama. Neither combination cream demonstrated superiority, but results align with previous findings.

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Area of Science:

  • Dermatology
  • Infectious Diseases
  • Parasitology

Background:

  • Cutaneous leishmaniasis (CL) is a parasitic skin disease caused by Leishmania species.
  • Topical paromomycin has shown efficacy against Leishmania major in Tunisia.
  • A Phase 3 trial was conducted in Panama to evaluate topical treatments against New World Leishmania species.

Purpose of the Study:

  • To compare the efficacy of a combination topical cream (paromomycin-gentamicin) versus paromomycin alone for treating CL.
  • To determine if the combination cream offered statistically superior cure rates for CL lesions.
  • To assess the safety and tolerability of the topical treatments.

Main Methods:

  • A randomized, double-blind, Phase 3 clinical trial was performed.
  • 399 patients with CL lesions were randomized to receive either paromomycin-gentamicin or paromomycin alone topical cream.
  • Treatment involved once-daily topical application for 20 days, with clinical cure of an index lesion as the primary endpoint.

Main Results:

  • The clinical cure rate for the paromomycin-gentamicin cream was 79%.
  • The clinical cure rate for the paromomycin alone cream was 78%.
  • No statistically significant difference in cure rates was observed between the two treatment groups (p = 0.84). Mild to moderate dermatitis, pain, and pruritus were the most common adverse events.

Conclusions:

  • The combination topical cream (paromomycin-gentamicin) did not demonstrate superiority over paromomycin alone for CL treatment in Panama.
  • Both topical treatments achieved approximately 80% cure rates, consistent with previous studies in Tunisia and with parenteral antimonials.
  • Topical paromomycin-based treatments remain a viable option for CL, particularly against New World Leishmania species.