Actively Recruiting

Phase 3
Age: 12Years +
All Genders
ID06822478

Randomized Blinded Clinical Trial to Evaluate the Safety and Efficacy of Arnica Tincture in the Topical Treatment of Cutaneous Leishmaniasis

Led by Universidad de Antioquia · Updated on 2026-04-02

96

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

Universidad de Antioquia

Lead Sponsor

I

INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of arnica tincture as a topical treatment for localized cutaneous leishmaniasis (CL), a parasitic skin disease caused by Leishmania species. The study compares arnica tincture to the current local treatment with intralesional pentavalent antimonials. This trial builds on prior research showing positive results for arnica tincture in Colombia and aims to offer a potentially safer option with fewer systemic side effects. This is a randomized, single-blind clinical trial including two treatment groups. One group will apply arnica tincture topically three times a day for 30 days, while the other will receive intralesional injections of pentavalent antimonials once weekly for five weeks, dosed by lesion size. Both treatments target localized skin lesions caused by CL, and the study evaluates the safety and healing outcomes of these approaches. Participants will be assessed through clinical examinations of their lesions at regular intervals up to 90 days post-treatment to measure healing rates. Safety will be monitored by recording adverse effects. Follow-up visits will continue for more than three months to observe final healing status and any treatment-related issues. The trial aims to provide data on both effectiveness and side effects to inform future treatment choices for CL patients.

CONDITIONS

Brief Title

Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis II.

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females aged 12 years or older with no upper age limit
  • Confirmed parasitological diagnosis of primary localized cutaneous leishmaniasis in at least one lesion
  • Clinical diagnosis of localized cutaneous leishmaniasis with ulcer, nodule, or plaque type lesions
  • Up to 9 lesions total with a combined area of 1875 mm2 or less
  • Ability to understand and comply with study requirements
  • Willingness and ability to attend all study visits
  • Signed informed consent or assent obtained
Not Eligible

You will not qualify if you...

  • Diagnosis or suspicion of mucosal, diffuse, disseminated leishmaniasis, relapse, or reactivation
  • Lesions located in ear, eye, nose, lip, joint areas, or other sites difficult for topical or intralesional treatment
  • History of significant cardiovascular, renal, hepatic, neurological, or immunological diseases that may affect treatment
  • Prior leishmaniasis treatment or any treatment affecting leishmaniasis within 8 weeks before enrollment
  • Women who are pregnant, breastfeeding, or of childbearing age not agreeing to use contraception during and until 45 days after treatment
  • Known or suspected hypersensitivity to arnica tincture or pentavalent antimonials
  • Unwillingness or inability to attend study visits or comply with follow-up for up to three months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 30 days for arnica tincture or 5 weeks for pentavalent antimonials

Participants apply arnica tincture topically three times a day on all lesions for 30 days, or receive intralesional pentavalent antimonials once a week for 5 weeks.

Weekly visits for up to 5 weeks for those receiving pentavalent antimonials; participants using arnica tincture apply it at home three times daily

Follow-up

Duration - Up to 75 days post-treatment

Participants are monitored for healing and safety outcomes after treatment ends, including assessment of lesion healing at day 90 and day 105 post-treatment.

Approximately 2 follow-up visits after treatment completion

Trial Site Locations

Total: 1 location

1

Grupo de Investigación Clínica PECET (GIC-PECET)

Medellín, Antioquia, Colombia, 0004

Actively Recruiting

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Research Team

I

Iván D Velez, PhD

L

Liliana Lopez, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Interventions for American cutaneous and mucocutaneous leishmaniasis: a systematic review update.

Ludovic Reveiz, Ana Nilce Silveira Maia-Elkhoury, Rubén Santiago Nicholls...

https://pubmed.ncbi.nlm.nih.gov/23637917