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Efficacy of topical Miltefosine formulations in an experimental model of cutaneous leishmaniasis

Ma Florencia Peralta1, Nadina A Usseglio1,2, Ma Estefanía Bracamonte3

  • 1Instituto de Investigación Médica Mercedes y Martín Ferreyra, INIMEC- CONICET- UNC, 5016, Córdoba, Argentina.

Drug Delivery and Translational Research
|January 27, 2021
PubMed

Insights

Topical treatment with miltefosine (Milt) in fluid liposomes effectively cured cutaneous leishmaniasis in mice, eliminating parasites and promoting skin healing without relapse. This approach offers a promising alternative to oral therapies with fewer side effects.

Area of Science:

  • Dermatology
  • Parasitology
  • Nanotechnology

Background:

  • Cutaneous leishmaniasis (CL) is a neglected tropical disease with increasing incidence.
  • Current treatments involve toxic systemic drugs like oral miltefosine (Milt), raising safety concerns.
  • A topical formulation could minimize systemic exposure and adverse effects.

Purpose of the Study:

  • To develop and evaluate topical miltefosine (Milt) formulations using liposomes for enhanced trans-epidermal delivery.
  • To assess the in vitro and in vivo efficacy, toxicity, and stability of Milt-loaded liposomes against Leishmania amazonensis.

Main Methods:

  • Preparation of Milt dispersions with liposomes of varying compositions.
  • In vitro and in vivo efficacy testing in BALB/c mice infected with Leishmania amazonensis.
  • Evaluation of drug release, particle size stability, and healing parameters.

Main Results:

  • Topical 0.5% Milt dispersions eliminated 99% of parasites, curing lesions with complete re-epithelization and hair regrowth.
  • Fluid liposomes accelerated lesion healing and parasite clearance.
  • No relapse was observed one month post-treatment.
  • Ultraflexible liposomes showed reduced in vivo efficacy.

Conclusions:

  • Topical miltefosine (Milt) formulated with fluid liposomes is a promising therapeutic strategy for cutaneous leishmaniasis.
  • This approach effectively treats CL with significant improvements in healing and parasite clearance.
  • The topical route minimizes systemic toxicity concerns associated with oral Milt.
Keywords:
Cutaneous leishmaniasisLiposomesMiltefosinePenetration enhancersTopical treatment

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