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New treatment option for Leishmaniasis, Cutaneous
Official title Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis II.
ClinicalTrials.gov ID: NCT06822478
What this study is testing
What is Arnica Tincture?
Arnica Tincture is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for leishmaniasis, cutaneous.
Also referred to as topical solution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Cutaneous leishmaniasis (CL) is a parasitic disease caused by more than 20 different species of the protozoan parasite Leishmania. CL usually begins with a papule at the site of the sandfly bite, which enlarges to form a nodule that progresses to an ulceration, or a scaly or warty plaque, over a period of 1 to 3 months.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Participants who meet the following 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...
- 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...
You likely can't join if
- Participants presenting one or more of the following criteria should be excluded from the study:
- Diagnosis or suspicion of mucosal/mucocutaneous, diffuse or disseminated Leishmaniasis or relapse or reactivation of an LC.
- people with lesions involving the auricular region, orbital region, nasal region and/or labial region of the face, joints or in places that, in the...
- History of clinically significant cardiovascular, renal, hepatic, hepatic, neurological or immunological diseases that may interact positively or...
- Having received treatment for Leishmaniasis or other treatment that, in the judgment of the investigator, may modify the course of infection with...
- 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...
See the full eligibility criteria
- Participants who meet the following 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)...
- 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. people who have given written IC/Assent. 7. Subject...
- Participants presenting one or more of the following criteria should be excluded from the study:
- Diagnosis or suspicion of mucosal/mucocutaneous, diffuse or disseminated Leishmaniasis or relapse or reactivation of an LC.
- people 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...
- History of clinically significant cardiovascular, renal, hepatic, hepatic, neurological or immunological diseases that may interact positively or negatively with the treatment.
- 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.
- 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.
- Known or suspected history of hypersensitivity or idiosyncratic reactions to the investigational product or pentavalent antimonials in the trial.
- people who are unwilling to attend study visits or who are unable to comply with follow-up visits for up to three months.
The study team makes the final eligibility decision.
Where it's taking place
- Medellín, Antioquia, Colombia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Medellín, Antioquia, Colombia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.