Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis II.

Launched by UNIVERSIDAD DE ANTIOQUIA · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Arnica Tincture for the Treatment of Cutaneous Leishmaniasis II," is exploring the effectiveness and safety of arnica tincture as a topical treatment for cutaneous leishmaniasis (CL), a skin disease caused by a parasite. The trial aims to compare arnica tincture to a standard treatment called intralesional pentavalent antimonials. CL typically starts as a small bump at the site of a sandfly bite, which can grow into a sore over time. The trial is open to males and females aged 12 and older who have a confirmed diagnosis of localized CL with specific types of lesions.

Participants in this study can expect to receive either arnica tincture or the standard treatment and will be monitored for any side effects. The study is looking for individuals who have up to nine lesions and can attend follow-up visits over three months. It's important to note that certain individuals, such as those with specific medical histories or who are currently pregnant, will not be eligible to participate. This trial is an exciting opportunity to explore a natural treatment option for CL, which could potentially offer a safer alternative for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants who meet the following inclusion criteria may enter the study and receive arnica tincture or intralesional pentavalent antimonials:
• • 1. Males or females, over 12 years of age and adults without age limit. With a confirmed parasitological diagnosis of a primary infection of LC in at least one lesion, made by one of the following methods: 1) microscopic identification of amastigotes in the lesion tissue; 2) diagnosis of leishmania by PCR; 3) positive culture for promastigotes (Annex 2).
• • 3. With clinical diagnosis of localized LC. 4. Ulcer, nodule or plaque type lesions. Up to 9 lesions in total, and that the total area of all lesions is ≤1875 mm2 6. Subjects who have given written IC/Assent. 7. Subject is able to understand and comply with the requirements of the study. 8. Subjects who are able to attend the control visits.
• Exclusion Criteria:
• Participants presenting one or more of the following criteria should be excluded from the study:
• • 1. Diagnosis or suspicion of mucosal/mucocutaneous, diffuse or disseminated Leishmaniasis or relapse or reactivation of an LC.
• • 2. Subjects with lesions involving the auricular region, orbital region, nasal region and/or labial region of the face, joints or in places that, in the opinion of the investigator, are difficult to apply topically or intralesionally to the study medication.
• • 3. History of clinically significant cardiovascular, renal, hepatic, hepatic, neurological or immunological diseases that may interact positively or negatively with the treatment.
• • 4. Having received treatment for Leishmaniasis or other treatment that, in the judgment of the investigator, may modify the course of infection with Leishmania in the last 8 weeks (56 days) prior to admission.
• • 5. Women with a positive pregnancy test during the screening process, or lactating, or women of childbearing age who do not agree to the use of contraceptives during treatment and until DPT45.
• • 6. Known or suspected history of hypersensitivity or idiosyncratic reactions to the investigational product or pentavalent antimonials in the trial.
• • 7. Subjects who are unwilling to attend study visits or who are unable to comply with follow-up visits for up to three months.