Leishmaniasis, CutaneousPhase 3ARNICANCT06822478
Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis II.
A Phase 3 study testing Arnica Tincture and Meglumine antimoniate. in people with Leishmaniasis, Cutaneous, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Leishmaniasis, Cutaneous
- What is being tested?
- Arnica Tincture and Meglumine antimoniate.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteColombia
- Study dates
- 11 Mar 2026to Feb 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- 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.
- Subjects who are unwilling to attend study visits or who are unable to comply with follow-up visits for up to three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Grupo de Investigación Clínica PECET (GIC-PECET)
Medellín, Antioquia, 0004
Liliana López, BSc.MSc, +574 2196506, liliana.lopez@pecet-colombia.org
About this study
Official title: Randomized Blinded Clinical Trial to Evaluate the Safety and Efficacy of Arnica Tincture in the Topical Treatment of Cutaneous Leishmaniasis.
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.
The exact incidence of CL is not known. An estimated 1.2 million cases/year in approximately 100 countries worldwide suffer from different forms of CL. More than 90% of CL cases occur in the Americas and Eastern Mediterranean regions. Afghanistan, Algeria, Brazil, Colombia, Iraq, Pakistan, and Syria report more than 80% of new CL cases worldwide. Since 2010, the World Health Organization has insisted on the need to work on products that become alternatives for the treatment of LC, especially in products that can be applied topically because with them the probability of systemic toxicity is lower, increasing patient safety.
Read more
Currently, it is recommended to apply local treatments for patients with localized LC, either with pentavalent antimonials administered intralesionally or with thermotherapy. Among the options for topical treatment are natural products that have been, are and will be of utmost importance as sources of medicinal agents. In addition to natural products that have found direct medicinal applications as pharmaceutical entities, many others can serve as chemical models or templates for the design, synthesis and semi-synthesis of novel substances for the treatment of human diseases.
Arnica montana L. is a plant with anti-emollient, healing, anti-inflammatory, analgesic and antineuralgic properties; it is included in the Colombian vademecum of medicinal plants.
In a randomized phase Ib/II clinical trial conducted in patients with localized LC in Colombia, 100% (per protocol analysis) and 92% (intention-to-treat analysis) efficacy was demonstrated, with no adverse effects other than those expected such as erythema, burning, pain or itching.
By demonstrating that arnica tincture is effective and safe, and that A. montana flower extracts in different preparations (topical solutions, tinctures, liniments, ointments or gels) are approved by the European Medicines Agency and are included in the vademecum of Colombian plants issued by the Ministry of Social Protection of Colombia in 2008, the present study aims to establish the safety and efficacy of arnica tincture as an alternative for the topical treatment of localized LC compared to a currently available local therapeutic alternative: intralesional pentavalent antimonials.
Read the detailed description
The exact incidence of LC is not known. For nearly 80 years, pentavalent antimony compounds: sodium stibogluconate (Pentostan®, produced by Glaxo-Wellcome) and meglumine antimoniate (Glucantime®, produced by Sanofi-Aventis) have been considered the first choice treatments for this disease despite their toxicity, difficult administration and high cost. A dose of 20 mg Sb5/kg/day for 20 days administered intramuscularly or parenterally is recommended in adult patients diagnosed with LC caused by L. braziliensis, L. panamensis, L. amazonensis, L. peruviana or L. mexicana. Pentavalent antimonials have many disadvantages such as parenteral administration and reversible side effects such as nausea, vomiting, muscle and abdominal pain, cardiac problems, increased hepatic aminotransferase concentration and chemical pancreatitis. In addition, adherence to treatment is affected by its duration (several weeks) and its availability due to restrictions on its distribution.
Since 2005, Miltefosine (hexadecylphosphocholine), an oral drug, has been proposed as the drug of first choice, especially in children diagnosed with LC caused by L. panamensis, L. mexicana, L. guyanensis or L. braziliensis; however, because it is potentially teratogenic, it is contraindicated during pregnancy and requires appropriate counseling of female patients of childbearing age and their partners in order to avoid pregnancies up to two months after the end of treatment. A dose of 50 mg for 28 days is recommended.
It is currently recommended to apply local treatments for patients with localized LC, either with pentavalent antimonials administered intralesionally or with thermotherapy. It is important to note that it is not mandatory to identify the Leishmania species to initiate treatment; however, if the most prevalent species in the region is known, treatment should be initiated according to the clinical condition of the patient, the availability of the drug and the risk-benefit balance.
PAHO recommends the use of local treatments for LC in situations in which the patient presents between 1 to 3 lesions, located in any area (except the head and periarticular areas), each lesion with an area of up to 900 mm2, with the absence of immunosuppression and the possibility of follow-up.
Arnica montana L. is a plant belonging to the Asteraceae family, which is composed of 28 to 32 species. This plant is endemic to central and southern Europe (Pyrenees and Alps), southern Scandinavia and northern Spain. It is a medicinal plant of ancestral use, recognized by several countries to alleviate various ailments. Its variety of indications can be explained by the production of a large amount of secondary metabolites such as sesquiterpene lactones (LST), flavonoids or phenolic acids. It has been demonstrated that arnica LSTs permeate through porcine skin and human skin, most of them (97%) are absorbed after 48 h and are retained in the skin, binding irreversibly to skin proteins, accumulating in the epidermis; suggesting that they do not reach systemic circulation being a safer and more beneficial treatment at local level.
The main indication corresponds to its anti-inflammatory activity. Helenalin-like LST (HL) and 11-α-13 dihydrohelenalin (DHL) are the constituents responsible for this effect, since these molecules decrease inflammation mediated by the transcription factor NF-kB. Additionally, there are other properties demonstrated in the literature such as antioxidant, antimicrobial or insecticidal activities.
Arnica tincture is a topical preparation based on the plant legally authorized in the countries of the European community and is included in the vademecun of medicinal plants in Colombia. The product under investigation is the commercial phytotherapeutic product Arnica Tintura Gehrlicher 100 mL manufactured by Gehrlicher Pharmazeutische Extrakte GmbH. According to the European Pharmacopoeia, the solution is a 70% hydroethanolic tincture prepared from the flowers of Arnica montana L., and compounded with at least 0.04% sesquiterpene lactones.
A randomized phase Ib/II clinical trial conducted in patients with localized LC in Colombia showed an efficacy of 100% (per protocol analysis) and 92% (intention-to-treat analysis), with no adverse effects other than those expected such as erythema, burning, pain or pruritus.
- Main objectives
- To evaluate the safety of arnica tincture in individuals with localized LC, by measuring occurrence and severity analysis of Adverse Effects (AEs), compared to treatment with pentavalent antimonials administered intralesionally.
- To evaluate the efficacy of arnica tincture in individuals with localized LC, according to the percentage of individuals and number of lesions with clinical healing corresponding to day 90 post-treatment, compared to treatment with pentavalent antimonials administered intralesionally.
- Secondary objectives.
- To evaluate the frequency and severity of AEs associated with the use of arnica tincture compared to treatment with intralesionally administered pentavalent antimonials.
- To evaluate the status of lesions over time to evidence of complete epithelialization/flattening of lesions, proportion of individuals with 100% epithelialization/flattening of lesions, and the number of epithelialized/non-indurated lesions in patients treated with tincture of arnica compared to treatment with intralesionally administered pentavalent antimonials.
- To compare the safety and efficacy of arnica tincture with treatment with intralesionally administered pentavalent antimonials.
To evaluate the overall risks and benefits of treatment with arnica tincture compared to treatment with intralesionally administered pentavalent antimonials.
- Conditions
- Leishmaniasis, Cutaneous
- Being tested
- Arnica Tincture, Meglumine antimoniate.
- Keywords
- Leishmaniasis, Cutáneo, Tintura de árnica
- Medical subject headings
- Leishmaniasis, Cutaneous, Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arnica TinctureDrug
Also called topical solution
Arnika tincture is a topical plant-based preparation legally authorized in Colombia and in the countries of the European community, the product of this study is Arnika tinktur Gehrlicher (5249), manufactured by Gehrlicher Pharmazeutische Extrakte GmbH, Germany. According to the European Pharmacopoeia, the solution is a 70% hydroethanolic tincture prepared from the flowers of A. montana L, and composed at least 0.04% of sesquiterpene lactones. Arnica tincture will be applied topically by each participant on all lesions until day 30.
Meglumine antimoniate.Drug
Also called intralesionally, Pentavalent antimonials
Monotherapy with intralesional pentavalent antimonials is one of the treatments of care used for LC in Colombia and will be used as a comparator for safety evaluation.
Pentavalent antimonials: administered intralesionally. At a dose of 0.008 ml X mm of area of each lesion, maximum 15 ml in total, once a week for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Regime 1. arnica tincture | Experimental | Regimen 1: tincture of arnica applied 3 times a day for 30 days. The participant applies the tincture in the morning, afternoon and evening, that is, three times a day. Receives: Drug: Arnica Tincture |
| Regime 2 Pentavalent antimonials intralesionally. | Active comparator | Administered intralesionally. At a dose of 0.008 ml X mm of area of each lesion, maximum 15 ml in total, once a week for 5 weeks. Receives: Drug: Meglumine antimoniate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with healing (scarring) after treatment
Defined as 100% epithelialization of the lesion (s) by day 90 post-treatment.
Measured: day 90
Secondary outcomes (1)
Number of participants with Final post-treatment Healing
initial cure with no recurrence and/or mucosal involvement at 90 days post-treatment evaluation to 105 days.
If the subject is withdrawn from the study because the lesion(s) are not healing, then the subject will also be considered a treatment failure. Any subject who has not had the lesion assessed at the scheduled times up to DPT105 will also be considered a failure in the ITT analysis.
Measured: day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start11 Mar 2026
- Primary completionDec 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Leishmaniasis, CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, single-blind, randomized, comparative study with two arms. After the informed consent process and verification of the eligibility criteria, volunteers will be randomly assigned to one of the interventions: 1: Arnica tincture, topical, with 3 applications per day for 30 days; 2: intralesional pentavalent antimonials for 5 weeks (1 application per week at a dose according to the lesion area). After initiation of treatment, a mid-treatment telephone or face-to-face follow-up will be performed depending on the treatment arm, in addition, follow-up visits will be made at the end of treatment (+ 7 days), day 45 post-treatment (+ 5 days) and day 90 post-treatment (+ 15 days) with an optional visit on day 105 post-treatment (+ 10 days), to evaluate the response to treatment and the safety of the treatment. The participant will keep a record of study medication application to document compliance with treatment and any symptoms experienced during treatment.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)
- Responsible party
- Sponsor
- Investigators
- Iván D Velez, PhD, Principal investigator, Clinical research group -Program for Research and Control in Tropical Diseases GIC - PECET, Medellín, Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822478
- Sponsor's protocol ID
- PEC01_2025
- Acronym
- ARNICA
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jurgens FM, Herrmann FC, Robledo SM, Schmidt TJ. Dermal Absorption of Sesquiterpene Lactones from Arnica Tincture. Pharmaceutics. 2022 Mar 29;14(4):742. doi: 10.3390/pharmaceutics14040742.
PubMed 35456576Guidelines of the International Conference on Harmonization - Good Clinical Practice: Consolidated Guide (ICH E6), E6(R2) Current Step 4 version dated 9 November 2016
Iannitti T, Morales-Medina JC, Bellavite P, Rottigni V, Palmieri B. Effectiveness and Safety of Arnica montana in Post-Surgical Setting, Pain and Inflammation. Am J Ther. 2016 Jan-Feb;23(1):e184-97. doi: 10.1097/MJT.0000000000000036.
PubMed 25171757Wagner S, Suter A, Merfort I. Skin penetration studies of Arnica preparations and of their sesquiterpene lactones. Planta Med. 2004 Oct;70(10):897-903. doi: 10.1055/s-2004-832613.
PubMed 15490315Velasco-Castrejon O, Walton BC, Rivas-Sanchez B, Garcia MF, Lazaro GJ, Hobart O, Roldan S, Floriani-Verdugo J, Munguia-Saldana A, Berzaluce R. Treatment of cutaneous leishmaniasis with localized current field (radio frequency) in Tabasco, Mexico. Am J Trop Med Hyg. 1997 Sep;57(3):309-12. doi: 10.4269/ajtmh.1997.57.309.
PubMed 9311641Lopez L, Robayo M, Vargas M, Velez ID. Thermotherapy. An alternative for the treatment of American cutaneous leishmaniasis. Trials. 2012 May 17;13:58. doi: 10.1186/1745-6215-13-58.
PubMed 22594858Lee SA, Hasbun R. Therapy of cutaneous leishmaniasis. Int J Infect Dis. 2003 Jun;7(2):86-93. doi: 10.1016/s1201-9712(03)90002-6.
PubMed 12839708Reveiz L, Maia-Elkhoury AN, Nicholls RS, Romero GA, Yadon ZE. Interventions for American cutaneous and mucocutaneous leishmaniasis: a systematic review update. PLoS One. 2013 Apr 29;8(4):e61843. doi: 10.1371/journal.pone.0061843. Print 2013.
PubMed 23637917Alvar J, Velez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team. Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671. doi: 10.1371/journal.pone.0035671. Epub 2012 May 31.
PubMed 22693548Votypka J, Kasap OE, Volf P, Kodym P, Alten B. Risk factors for cutaneous leishmaniasis in Cukurova region, Turkey. Trans R Soc Trop Med Hyg. 2012 Mar;106(3):186-90. doi: 10.1016/j.trstmh.2011.12.004. Epub 2012 Jan 26.
PubMed 22284721Croft SL, Seifert K, Yardley V. Current scenario of drug development for leishmaniasis. Indian J Med Res. 2006 Mar;123(3):399-410.
PubMed 16778319Velez I, Lopez L, Sanchez X, Mestra L, Rojas C, Rodriguez E. Efficacy of miltefosine for the treatment of American cutaneous leishmaniasis. Am J Trop Med Hyg. 2010 Aug;83(2):351-6. doi: 10.4269/ajtmh.2010.10-0060.
PubMed 20682881Herwaldt BL. Leishmaniasis. Lancet. 1999 Oct 2;354(9185):1191-9. doi: 10.1016/S0140-6736(98)10178-2.
PubMed 10513726Tiuman TS, Santos AO, Ueda-Nakamura T, Filho BP, Nakamura CV. Recent advances in leishmaniasis treatment. Int J Infect Dis. 2011 Aug;15(8):e525-32. doi: 10.1016/j.ijid.2011.03.021. Epub 2011 May 24.
PubMed 21605997Almeida OL, Santos JB. Advances in the treatment of cutaneous leishmaniasis in the new world in the last ten years: a systematic literature review. An Bras Dermatol. 2011 May-Jun;86(3):497-506. doi: 10.1590/s0365-05962011000300012. English, Portuguese.
PubMed 21738967
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Blinded Clinical Trial to Evaluate the Safety and Efficacy of Arnica Tincture in the Topical Treatment of Cutaneous Leishmaniasis.
- ClinicalTrials.gov ID
- NCT06822478
- Acronym / sponsor ID
- ARNICA / PEC01_2025
- Conditions
- Leishmaniasis, Cutaneous
- Keywords
- Leishmaniasis, Cutáneo, Tintura de árnica
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The exact incidence of CL is not known. An estimated 1.2 million cases/year in approximately 100 countries worldwide suffer from different forms of CL. More than 90% of CL cases occur in the Americas and Eastern Mediterranean regions. Afghanistan, Algeria, Brazil, Colombia, Iraq, Pakistan, and Syria report more than 80% of new CL cases worldwide. Since 2010, the World Health Organization has insisted on the need to work on products that become alternatives for the treatment of LC, especially in products that can be applied topically because with them the probability of systemic toxicity is lower, increasing patient safety.
Currently, it is recommended to apply local treatments for patients with localized LC, either with pentavalent antimonials administered intralesionally or with thermotherapy. Among the options for topical treatment are natural products that have been, are and will be of utmost importance as sources of medicinal agents. In addition to natural products that have found direct medicinal applications as pharmaceutical entities, many others can serve as chemical models or templates for the design, synthesis and semi-synthesis of novel substances for the treatment of human diseases.
Arnica montana L. is a plant with anti-emollient, healing, anti-inflammatory, analgesic and antineuralgic properties; it is included in the Colombian vademecum of medicinal plants.
In a randomized phase Ib/II clinical trial conducted in patients with localized LC in Colombia, 100% (per protocol analysis) and 92% (intention-to-treat analysis) efficacy was demonstrated, with no adverse effects other than those expected such as erythema, burning, pain or itching.
By demonstrating that arnica tincture is effective and safe, and that A. montana flower extracts in different preparations (topical solutions, tinctures, liniments, ointments or gels) are approved by the European Medicines Agency and are included in the vademecum of Colombian plants issued by the Ministry of Social Protection of Colombia in 2008, the present study aims to establish the safety and efficacy of arnica tincture as an alternative for the topical treatment of localized LC compared to a currently available local therapeutic alternative: intralesional pentavalent antimonials.
Detailed description
The exact incidence of LC is not known. For nearly 80 years, pentavalent antimony compounds: sodium stibogluconate (Pentostan®, produced by Glaxo-Wellcome) and meglumine antimoniate (Glucantime®, produced by Sanofi-Aventis) have been considered the first choice treatments for this disease despite their toxicity, difficult administration and high cost. A dose of 20 mg Sb5/kg/day for 20 days administered intramuscularly or parenterally is recommended in adult patients diagnosed with LC caused by L. braziliensis, L. panamensis, L. amazonensis, L. peruviana or L. mexicana. Pentavalent antimonials have many disadvantages such as parenteral administration and reversible side effects such as nausea, vomiting, muscle and abdominal pain, cardiac problems, increased hepatic aminotransferase concentration and chemical pancreatitis. In addition, adherence to treatment is affected by its duration (several weeks) and its availability due to restrictions on its distribution.
Since 2005, Miltefosine (hexadecylphosphocholine), an oral drug, has been proposed as the drug of first choice, especially in children diagnosed with LC caused by L. panamensis, L. mexicana, L. guyanensis or L. braziliensis; however, because it is potentially teratogenic, it is contraindicated during pregnancy and requires appropriate counseling of female patients of childbearing age and their partners in order to avoid pregnancies up to two months after the end of treatment. A dose of 50 mg for 28 days is recommended.
It is currently recommended to apply local treatments for patients with localized LC, either with pentavalent antimonials administered intralesionally or with thermotherapy. It is important to note that it is not mandatory to identify the Leishmania species to initiate treatment; however, if the most prevalent species in the region is known, treatment should be initiated according to the clinical condition of the patient, the availability of the drug and the risk-benefit balance.
PAHO recommends the use of local treatments for LC in situations in which the patient presents between 1 to 3 lesions, located in any area (except the head and periarticular areas), each lesion with an area of up to 900 mm2, with the absence of immunosuppression and the possibility of follow-up.
Arnica montana L. is a plant belonging to the Asteraceae family, which is composed of 28 to 32 species. This plant is endemic to central and southern Europe (Pyrenees and Alps), southern Scandinavia and northern Spain. It is a medicinal plant of ancestral use, recognized by several countries to alleviate various ailments. Its variety of indications can be explained by the production of a large amount of secondary metabolites such as sesquiterpene lactones (LST), flavonoids or phenolic acids. It has been demonstrated that arnica LSTs permeate through porcine skin and human skin, most of them (97%) are absorbed after 48 h and are retained in the skin, binding irreversibly to skin proteins, accumulating in the epidermis; suggesting that they do not reach systemic circulation being a safer and more beneficial treatment at local level.
The main indication corresponds to its anti-inflammatory activity. Helenalin-like LST (HL) and 11-α-13 dihydrohelenalin (DHL) are the constituents responsible for this effect, since these molecules decrease inflammation mediated by the transcription factor NF-kB. Additionally, there are other properties demonstrated in the literature such as antioxidant, antimicrobial or insecticidal activities.
Arnica tincture is a topical preparation based on the plant legally authorized in the countries of the European community and is included in the vademecun of medicinal plants in Colombia. The product under investigation is the commercial phytotherapeutic product Arnica Tintura Gehrlicher 100 mL manufactured by Gehrlicher Pharmazeutische Extrakte GmbH. According to the European Pharmacopoeia, the solution is a 70% hydroethanolic tincture prepared from the flowers of Arnica montana L., and compounded with at least 0.04% sesquiterpene lactones.
A randomized phase Ib/II clinical trial conducted in patients with localized LC in Colombia showed an efficacy of 100% (per protocol analysis) and 92% (intention-to-treat analysis), with no adverse effects other than those expected such as erythema, burning, pain or pruritus.
- Main objectives
- To evaluate the safety of arnica tincture in individuals with localized LC, by measuring occurrence and severity analysis of Adverse Effects (AEs), compared to treatment with pentavalent antimonials administered intralesionally.
- To evaluate the efficacy of arnica tincture in individuals with localized LC, according to the percentage of individuals and number of lesions with clinical healing corresponding to day 90 post-treatment, compared to treatment with pentavalent antimonials administered intralesionally.
- Secondary objectives.
- To evaluate the frequency and severity of AEs associated with the use of arnica tincture compared to treatment with intralesionally administered pentavalent antimonials.
- To evaluate the status of lesions over time to evidence of complete epithelialization/flattening of lesions, proportion of individuals with 100% epithelialization/flattening of lesions, and the number of epithelialized/non-indurated lesions in patients treated with tincture of arnica compared to treatment with intralesionally administered pentavalent antimonials.
- To compare the safety and efficacy of arnica tincture with treatment with intralesionally administered pentavalent antimonials.
To evaluate the overall risks and benefits of treatment with arnica tincture compared to treatment with intralesionally administered pentavalent antimonials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a single-center, single-blind, randomized, comparative study with two arms. After the informed consent process and verification of the eligibility criteria, volunteers will be randomly assigned to one of the interventions: 1: Arnica tincture, topical, with 3 applications per day for 30 days; 2: intralesional pentavalent antimonials for 5 weeks (1 application per week at a dose according to the lesion area). After initiation of treatment, a mid-treatment telephone or face-to-face follow-up will be performed depending on the treatment arm, in addition, follow-up visits will be made at the end of treatment (+ 7 days), day 45 post-treatment (+ 5 days) and day 90 post-treatment (+ 15 days) with an optional visit on day 105 post-treatment (+ 10 days), to evaluate the response to treatment and the safety of the treatment. The participant will keep a record of study medication application to document compliance with treatment and any symptoms experienced during treatment.
| Arm | Type | Receives |
|---|---|---|
| Regime 1. arnica tincture | Experimental | Drug: Arnica TinctureRegimen 1: tincture of arnica applied 3 times a day for 30 days. The participant applies the tincture in the morning, afternoon and evening, that is, three times a day. |
| Regime 2 Pentavalent antimonials intralesionally. | Active comparator | Drug: Meglumine antimoniate.Administered intralesionally. At a dose of 0.008 ml X mm of area of each lesion, maximum 15 ml in total, once a week for 5 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arnica TinctureAlso: topical solutionArnika tincture is a topical plant-based preparation legally authorized in Colombia and in the countries of the European community, the product of this study is Arnika tinktur Gehrlicher (5249), manufactured by Gehrlicher Pharmazeutische Extrakte GmbH, Germany. According to the European Pharmacopoeia, the solution is a 70% hydroethanolic tincture prepared from the flowers of A. montana L, and composed at least 0.04% of sesquiterpene lactones. Arnica tincture will be applied topically by each participant on all lesions until day 30. | Drug | Regime 1. arnica tincture |
| Meglumine antimoniate.Also: intralesionally, Pentavalent antimonialsMonotherapy with intralesional pentavalent antimonials is one of the treatments of care used for LC in Colombia and will be used as a comparator for safety evaluation. Pentavalent antimonials: administered intralesionally. At a dose of 0.008 ml X mm of area of each lesion, maximum 15 ml in total, once a week for 5 weeks. | Drug | Regime 2 Pentavalent antimonials intralesionally. |
Primary outcome
Number of participants with healing (scarring) after treatment
Time frame: day 90
Defined as 100% epithelialization of the lesion (s) by day 90 post-treatment.
1 secondary outcome
Number of participants with Final post-treatment Healing
Time frame: day 105
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 35456576Jurgens FM, Herrmann FC, Robledo SM, Schmidt TJ. Dermal Absorption of Sesquiterpene Lactones from Arnica Tincture. Pharmaceutics. 2022 Mar 29;14(4):742. doi: 10.3390/pharmaceutics14040742.
- BackgroundGuidelines of the International Conference on Harmonization - Good Clinical Practice: Consolidated Guide (ICH E6), E6(R2) Current Step 4 version dated 9 November 2016
- Background: PubMed 25171757Iannitti T, Morales-Medina JC, Bellavite P, Rottigni V, Palmieri B. Effectiveness and Safety of Arnica montana in Post-Surgical Setting, Pain and Inflammation. Am J Ther. 2016 Jan-Feb;23(1):e184-97. doi: 10.1097/MJT.0000000000000036.
- Background: PubMed 15490315Wagner S, Suter A, Merfort I. Skin penetration studies of Arnica preparations and of their sesquiterpene lactones. Planta Med. 2004 Oct;70(10):897-903. doi: 10.1055/s-2004-832613.
- Background: PubMed 9311641Velasco-Castrejon O, Walton BC, Rivas-Sanchez B, Garcia MF, Lazaro GJ, Hobart O, Roldan S, Floriani-Verdugo J, Munguia-Saldana A, Berzaluce R. Treatment of cutaneous leishmaniasis with localized current field (radio frequency) in Tabasco, Mexico. Am J Trop Med Hyg. 1997 Sep;57(3):309-12. doi: 10.4269/ajtmh.1997.57.309.
- Background: PubMed 22594858Lopez L, Robayo M, Vargas M, Velez ID. Thermotherapy. An alternative for the treatment of American cutaneous leishmaniasis. Trials. 2012 May 17;13:58. doi: 10.1186/1745-6215-13-58.
- Background: PubMed 12839708Lee SA, Hasbun R. Therapy of cutaneous leishmaniasis. Int J Infect Dis. 2003 Jun;7(2):86-93. doi: 10.1016/s1201-9712(03)90002-6.
- Background: PubMed 23637917Reveiz L, Maia-Elkhoury AN, Nicholls RS, Romero GA, Yadon ZE. Interventions for American cutaneous and mucocutaneous leishmaniasis: a systematic review update. PLoS One. 2013 Apr 29;8(4):e61843. doi: 10.1371/journal.pone.0061843. Print 2013.
- Background: PubMed 22693548Alvar J, Velez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team. Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671. doi: 10.1371/journal.pone.0035671. Epub 2012 May 31.
- Background: PubMed 22284721Votypka J, Kasap OE, Volf P, Kodym P, Alten B. Risk factors for cutaneous leishmaniasis in Cukurova region, Turkey. Trans R Soc Trop Med Hyg. 2012 Mar;106(3):186-90. doi: 10.1016/j.trstmh.2011.12.004. Epub 2012 Jan 26.
- Background: PubMed 16778319Croft SL, Seifert K, Yardley V. Current scenario of drug development for leishmaniasis. Indian J Med Res. 2006 Mar;123(3):399-410.
- Background: PubMed 20682881Velez I, Lopez L, Sanchez X, Mestra L, Rojas C, Rodriguez E. Efficacy of miltefosine for the treatment of American cutaneous leishmaniasis. Am J Trop Med Hyg. 2010 Aug;83(2):351-6. doi: 10.4269/ajtmh.2010.10-0060.
- Common Terminology Criteria for Adverse Events (CTCAE)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iván D Velez, PhD principal investigator
Clinical research group -Program for Research and Control in Tropical Diseases GIC - PECET, Medellín, Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arnica Tincture and Meglumine antimoniate. in people with Leishmaniasis, Cutaneous, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iván D Velez, PhD (+57(604)42196506, idvelez@pecet-colombia.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with healing (scarring) after treatment (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06822478, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.