Arnica tincture for treating cutaneous leishmaniasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study compares topical arnica tincture to intralesional meglumine antimoniate in patients with parasitologically confirmed localized cutaneous leishmaniasis. Eligible participants are aged 12 and up with up to nine lesions and a total lesion area within the study limit, and they receive assigned local treatment with regular follow-up visits to monitor lesion healing and safety. Outcomes include lesion resolution and treatment tolerability, with clinical and laboratory checks during the follow-up period. The trial is conducted at a clinical research center in Medellín, Colombia and aims to offer a non‑systemic therapeutic option.

Why it matters

Who can join: the full rules

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.

Where it's running

• Grupo de Investigación Clínica PECET (GIC-PECET)
  Medellín, Antioquia, Colombia Recruiting

Study contacts

• Principal investigator: Iván D Velez, PhD — Clinical research group -Program for Research and Control in Tropical Diseases GIC - PECET, Medellín, Antioquia
• Study coordinator: Iván D Velez, PhD
• Email: idvelez@pecet-colombia.org
• Phone: +57(604)42196506

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.