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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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)

Criteria

Inclusion Criteria:

• Men and women between 18 - 60 years.

• Patient with confirmed parasitological diagnosis of CL in at least one lesion, performed at least through the following methods: 1) microscopic identification of amastigotes in tissue of the lesion; 2) Leishmania diagnose through PCR; 3) positive culture for promastigotes.

• Patient with a lesion that meets the following criteria:

. Ulcer or nodule with a maximum size of 4 cm (the largest diameter).

• Not located in the ear, face, near mucous membranes, joints, or in places that, in the opinion of the PI, the study medication is difficult to apply topically.

• Patient with a maximum of four CL lesions.

• The duration of the lesion is less than three months according to the patient's history.

• The patient is able to give written informed consent.

• Patients whom the investigator believes are able to understand and are willing to comply with the requirements of the protocol.

Exclusion Criteria:

Patients who meet some of the following criteria must be excluded from the study:

• Women with positive pregnancy test during the screening process, or who are lactating; or women of childbearing age who do not agree to take contraceptives during treatment and until Day 45.

• The subject has a history of significant medical conditions or treatments that may interact negatively or positively with the topical treatment of Leishmaniasis, including any immune compromise condition.

• Within eight weeks (56 days) of beginning the study treatments, having received treatment for Leishmaniasis through any medication, including Glucantime that probably, in the opinion of the principal investigator (PI), might modify the course of the infection by Leishmania.

• Based on physical examinations performed, they have been diagnosed, or a diagnosis of Mucocutaneous Leishmaniasis is suspected.

• Known history or suspected hypersensitivity or idiosyncratic reactions to the study medication.

• Patients who do not wish to attend study appointments or who cannot keep up with follow-up visits for up to 6 months