Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis
Status:
Not yet recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Cutaneous Leishmaniasis (CL) is a parasitic disease caused by more than 20 different species
of the protozoan parasite Leishmania. CL generally begins with a papule at the sand fly bite
site, increasing to form a nodule that progresses to ulceration, or a scaly or wart-like
plaque, over a period of 1 to 3 months.
The exact incidence of CL is not known. An estimated 1.2 million cases / year in
approximately 100 countries around the world suffer from different forms of CL. In general,
most lesions become ulcerated during the course of the disease. Among the different species
of the parasite that cause LC, L. tropica from the Old World and L. braziliensis from the New
World are considered the most important due to the severity of the disease they produce and
because they are more difficult to cure with medications currently available.
Since 2010, the World Health Organization has insisted on the need to work on products that
become alternatives for the treatment of CL, especially in products that serve topical
application because with them, the probability of systemic toxicity is lower , increasing
patient safety.
Among the options for topical treatment are natural products that have been, are, and will be
extremely important as sources of medicinal agents. In addition to natural products that have
found direct medicinal application as pharmaceutical entities, many others can serve as
chemical models or templates for the design, synthesis and semi-synthesis of novel substances
for the treatment of human diseases.
Arnica montana L. is a plant with anti-echemotic, healing, anti-inflammatory, analgesic and
antineuralgic properties; It is included in the Colombian vademecum of medicinal plants. In
previous studies it has been observed that the contact of the ulcerated skin with the product
for up to 60 days does not generate toxic effects at the local level (application site) or at
the systemic level, so it can be considered safe for use. To date there are no human studies
with CL.
Therefore, it is intended to evaluate the safety and tolerability of Arnica tincture in
individuals with uncomplicated CL, by measuring the occurrence and severity analysis of local
and systemic adverse events.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Universidad de Antioquia
Collaborator:
INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)