Arnica tincture for treating cutaneous leishmaniasis
Randomized Blinded Clinical Trial to Evaluate the Safety and Efficacy of Arnica Tincture in the Topical Treatment of Cutaneous Leishmaniasis.
This test will see if applying arnica tincture to skin lesions helps heal cutaneous leishmaniasis in people aged 12 and older.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Universidad de Antioquia Academic / other |
| Locations | 1 site (Medellín, Antioquia) |
| Trial ID | NCT06822478 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: People aged 12 years and older with parasitologically confirmed localized cutaneous leishmaniasis who have up to nine lesions with a combined area within the study limit and who can attend scheduled follow-up visits.
Not a fit: Patients with non‑localized (mucosal or disseminated) leishmaniasis, lesions exceeding the study size/number limits, or those unable to attend in‑person follow‑up are unlikely to benefit from this study treatment.
Why it matters
Potential benefit: If successful, a topical arnica tincture could provide an easier, less toxic local treatment option that avoids injections and systemic side effects.
How similar studies have performed: Topical and local treatments for cutaneous leishmaniasis have shown benefit in some prior studies, but using arnica tincture is relatively novel and not yet widely tested in large trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Medellín, Antioquia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.