Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad de Antioquia
• Collaborator: INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)

Criteria

Inclusion Criteria:

• Men or women, of legal age, between 18 and 65 years old.

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

• Subjects with an injury 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 where, in the opinion of the IP, the administration of the product is difficult to apply topically.

• Subjects with a maximum of 4 LC lesions.

• Injury with an evolution of less than 4 months according to the subject's history.

• Subjects who have given their CI in writing.

• At the discretion of the IP, the subject is able to understand and comply with the requirements of the study.

• Subjects who can attend control visits.

Exclusion Criteria:

• Women with a positive pregnancy test during the screening process, or breastfeeding, or women of childbearing potential who do not accept the use of contraceptives during treatment and up to 45 days after treatment.

• History of clinically significant medical problems or treatments that may interact negatively or positively with topical treatment for Leishmaniasis, including any immunocompromising conditions.

• Within 8 weeks (56 days) of starting the study treatment, having received treatment for Leishmaniasis with any type of medication, including Glucantime that probably, in the opinion of the PI, could modify the course of infection with Leishmania.

• Based on physical examinations performed, a diagnosis of CML has been or is suspected.

• Known or suspected history of hypersensitivity or idiosyncratic reactions to study treatment.

• Present the following laboratory alterations:

• Serum creatinine above normal levels

• ALT / AST levels 3 times above the normal value (according to the levels reported by the local laboratory).

• Subjects who do not want to keep study appointments or who cannot keep follow-up visits for up to six months.