Evaluation of the Safety and Clinical Activity of Curaleish in the Topical Treatment of Cutaneous Leishmaniasis.
Status:
Suspended
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Cutaneous Leishmaniasis (CL) is a parasitic disease caused by more than 15 different species
of the protozoan parasite Leishmania. The CL usually begins with a papule at the site of the
sandfly bite, increasing in size to form a nodule that ulcerates in a period of 1 to 3
months.
The exact incidence of CL is not known. An estimated 1.2 million cases/year in approximately
102 countries worldwide suffer from different forms of CL. Among the different parasites that
cause CL, L.tropica in the Old World and L.braziliensis in the New World are considered to be
the most important due to the difficulty of healing, the public importance and the severity
of the disease.
Pentavalent antimony remains the first choice drug for the treatment of CL and the evidence
to support its use is sometimes based on qualitative, retrospective and uncontrolled
observations, with only some controlled clinical studies. Antimonials are widely used despite
their toxicity, difficulty in the route of administration, and high cost.
Miltefosine (hexadecylphosphocholine), an oral medication that has proven effective for some
types of Leishmania, is potentially teratogenic, is contraindicated during pregnancy and
requires appropriate counseling for female patients of childbearing age.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Universidad de Antioquia
Collaborators:
Comprehensive Strategy for the Control of Leishmaniasis in Colombia INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)