Leishmaniasis, CutaneousPhase 1ARNICANCT05094908
Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis
A Phase 1 study testing Arnica Tincture 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 generally begins with a papule at the sand fly bite site, increasing to form a nodule that progresses to ulceration, or a scaly or wart-like plaque, over a period of 1 to 3 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leishmaniasis, Cutaneous
- What is being tested?
- Arnica Tincture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteColombia
- Study dates
- 3 May 2023to Aug 2025
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, of legal age, between 18 and 65 years old.
- With a confirmed parasitological diagnosis of CL in at least one lesion, performed at least through the following methods: 1) microscopic identification of amastigotes in the lesion tissue; 2) diagnosis of leishmania through PCR; 3) positive culture for promastigotes.
- Subjects with an injury that meets the following criteria:
- Ulcer or nodule with a maximum size of 4 cm (the largest diameter).
- Not located in the ear, face, near mucous membranes, joints, or in places where, in the opinion of the IP, the administration of the product is difficult to apply topically.
- Subjects with a maximum of 4 LC lesions.
Show all 10Show fewer
- Injury with an evolution of less than 4 months according to the subject's history.
- Subjects who have given their CI in writing.
- At the discretion of the IP, the subject is able to understand and comply with the requirements of the study.
- Subjects who can attend control visits.
Who cannot join
- Women with a positive pregnancy test during the screening process, or breastfeeding, or women of childbearing potential who do not accept the use of contraceptives during treatment and up to 45 days after treatment.
- History of clinically significant medical problems or treatments that may interact negatively or positively with topical treatment for Leishmaniasis, including any immunocompromising conditions.
- Within 8 weeks (56 days) of starting the study treatment, having received treatment for Leishmaniasis with any type of medication, including Glucantime that probably, in the opinion of the PI, could modify the course of infection with Leishmania.
- Based on physical examinations performed, a diagnosis of CML has been or is suspected.
- Known or suspected history of hypersensitivity or idiosyncratic reactions to study treatment.
- Present the following laboratory alterations:
Show all 9Show fewer
- Serum creatinine above normal levels
- ALT / AST levels 3 times above the normal value (according to the levels reported by the local laboratory).
- Subjects who do not want to keep study appointments or who cannot keep follow-up visits for up to six months.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Program for Research and Control in Tropical Diseases - PECET
Medellín, Antioquia, 0004
About this study
Official title: Randomized Clinical Trial to Evaluate the Safety and Therapeutic Response of Two ARNICA TINCTURE Treatment Regimes in the Topical Treatment of Uncomplicated Cutaneous Leishmaniasis in Colombia
Cutaneous Leishmaniasis (CL) is a parasitic disease caused by more than 20 different species of the protozoan parasite Leishmania. CL generally begins with a papule at the sand fly bite site, increasing to form a nodule that progresses to ulceration, or a scaly or wart-like 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 around the world suffer from different forms of CL. In general, most lesions become ulcerated during the course of the disease. Among the different species of the parasite that cause LC, L. tropica from the Old World and L. braziliensis from the New World are considered the most important due to the severity of the disease they produce and because they are more difficult to cure with medications currently available.
Read more
Since 2010, the World Health Organization has insisted on the need to work on products that become alternatives for the treatment of CL, especially in products that serve topical application because with them, the probability of systemic toxicity is lower , increasing patient safety.
Among the options for topical treatment are natural products that have been, are, and will be extremely important as sources of medicinal agents. In addition to natural products that have found direct medicinal application 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-echemotic, healing, anti-inflammatory, analgesic and antineuralgic properties; It is included in the Colombian vademecum of medicinal plants. In previous studies it has been observed that the contact of the ulcerated skin with the product for up to 60 days does not generate toxic effects at the local level (application site) or at the systemic level, so it can be considered safe for use. To date there are no human studies with CL.
Therefore, it is intended to evaluate the safety and tolerability of Arnica tincture in individuals with uncomplicated CL, by measuring the occurrence and severity analysis of local and systemic adverse events.
Read the detailed description
Arnica tincture is a topical preparation based on the plant legally authorized in the countries of the European community, and it is included in the vademecun of medicinal plants in Colombia. The research product is the commercial phytotherapeutic product ARNICA TINTURA Gehrlicher 100 mL manufactured by Gehrlicher Pharmazeutische Extrakte GmbH. (www. https://www.wer-zu-wem.de/firma/gehrlicher-extrakte.html). The product will be imported from Germany through the University of Munster (project co-investigator).
According to the European Pharmacopoeia, the solution is a 70% hydroethanolic tincture prepared from the flowers of Arnica montana L, and composed at least 0.04% of sesquiterpene lactones. Sesquiterpenic lactones (helenalin and 11-α-13 dihydrohelenaline) are the constituents responsible for its anti-inflammatory activity, these molecules decrease inflammation mediated by the transcription factor NF-kB. There are other properties demonstrated in the literature such as antioxidant, antimicrobial or insecticidal activities.
Given the plant's anti-inflammatory, healing, anti-echemotic, analgesic and antineuralgic properties, in a previous study the leishmanicidal activity of arnica tincture was evaluated in vitro for intracellular amastigotes of L. braziliensis and L. tropica. Arnica tincture at a concentration of 4.8 mg / mL produced a decrease in the parasite load (amount of intracellular amastigotes) of 91.9% and 99.6% in cells infected by L. braziliensis and L. tropica, respectively. . The mean maximum Effective Concentrations (EC50) were determined at 2.9 ± 0.13 and 2.7 ± 0.02 respectively, and with selectivity indices> 69 and> 74, for L. braziliensis and L. tropica, respectively. This activity was validated in in vivo studies in hamsters experimentally infected with L. braziliensis. Applying the tincture once a day for 30 days produced a cure of 60 and for the remaining 40% of the hamsters a reduction of more than 80% of the lesions was observed (Robledo et al., 2018). When applied once a day for 60 days, 75% of the hamsters were cured and the remaining 25% showed improvements between 70 and 96% regarding the size of the lesion before treatment. According to the observations made, it is part of the natural evolution of the healing process that, during the first weeks of use of the compound and until the end of the treatment, a flattening of the edges is perceived, with intensification of the erythema, which produces a Optical sensation of enlargement of the lesion, which subsequently (from day 28) gives rise to the re-epithelialization process, which is slightly slower compared to traditional systemic schemes. The percentage of epithelialization of the lesion (s) is calculated by comparing the size of the ulcer at baseline against the size observed at the follow-up visit.
Arnica tincture is not cytotoxic on epithelial cells (Detroit) at any concentrations tested. In liver cells (HepG2) the tincture showed a slight cytotoxicity when evaluated at 100%, with a toxicity percentage of 75%. Weight, clinical appearance, and behavior data, as well as ALT, alkaline phosphatase, creatinine, and urea test results; and the histological studies obtained from the tests in hamsters allowed to conclude that the contact of the ulcerated skin with the product for up to 60 days does not generate toxic effects at the local level (application site) or at the systemic level, so it can be considered as safe for use. Corrosion and irritation tests to evaluate arnica skin tincture according to OECD guidelines suggest that it is neither corrosive nor irritating.
Although it is difficult to calculate accurately, it has been estimated that approximately 2 drops (80uL) of the solution will be used per cm2 in each application. If we consider an average lesion size of 4 cm2, a maximum of 320 uL is used X 3 times a day X 45 or 30 days = 43,200 uL or 28,800uL (equivalent to 43.2 or 28.8 mL) per lesion.
- Main Objectives
- Evaluate the safety and tolerability of Arnica tincture in individuals with uncomplicated CL, by measuring the occurrence and severity analysis of local and systemic ADs.
- Evaluate the therapeutic response of Arnica tincture in individuals with uncomplicated CL, according to the percentage of individuals with initial clinical cure on day 90. Regimen 1: Arnica tincture applied 3 times a day for 30 days (Group 1: 4 weeks) Regimen 2: Arnica tincture applied 3 times a day for 45 days (Group 2: 6 weeks)
- Secondary Objectives
- Evaluate the frequency and severity of AEs associated with the use of the Arnica tincture solution.
- Assess the status of the lesions over time, up to 100% epithelialization of ulcerated lesions and proportion of individuals with 100% epithelialization of non-ulcerated lesions over time.
- Assess the relapse rate.
- Conditions
- Leishmaniasis, Cutaneous
- Being tested
- Arnica Tincture
- Keywords
- Leishmaniasis, Cutaneous, Arnica tincture
- 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 or 45, depending on the regimen to be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Regime 1 (30 days) | Active comparator | Regimen 1: arnica tincture applied 3 times a day for 30 days (group 1). For both regimens, the participant applies the tincture in the morning, afternoon and evening, that is, three times a day. Receives: Drug: Arnica Tincture |
| Regime 2 (45 days) | Active comparator | Regimen 2 arnica tincture applied 3 times a day for 45 days (group 2). For both regimens, the participant applies the tincture in the morning, afternoon and evening, that is, three times a day. Receives: Drug: Arnica Tincture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Initial post-treatment healing
defined as 100% epithelialization of the lesion (s) by day 90 post-treatment.
Measured: day 90
Secondary outcomes (2)
Number of participants with Final post-treatment Healing
initial healing without relapse and / or mucosal compromise at the 180th day post-treatment evaluation
Measured: day 180
Number of participants with lesions that relapse
lesion that achieves 100% epithelialization by Day 90 post-treatment and then returned to show activity by day 180 post-treatment.
Measured: day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start3 May 2023
- Primary completion2 Nov 2024
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open, randomized, non-comparative, exploratory study with two arms. After the informed consent process and the verification of eligibility criteria, the volunteers will be randomly assigned to one of the interventions (30- or 45-day arnica tincture regimen) of the study. All individuals will have a telephone follow-up in the middle of the treatment, in addition, follow-up visits will be made at the end of the therapy, on day 45 post-treatment ± 5 days, on day 60 post-treatment ± 5 days (optional visit), on days 90 post-treatment ± 14 days and 180 days post-treatment-14 + 28 days to evaluate the therapeutic response. The participant will keep a record of the daily application (morning, afternoon and evening) of the study medication to document its application.
- Masking
- None (open label)
- Enrolment
- 16 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
- Ivan D Velez, PhD, Principal investigator, Director PECET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094908
- Sponsor's protocol ID
- PEC02_2021
- Acronym
- ARNICA
- Status last verified
- Feb 2025
- First submitted
- 28 Sep 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robledo SM, Velez ID, Schmidt TJ. Arnica Tincture Cures Cutaneous Leishmaniasis in Golden Hamsters. Molecules. 2018 Jan 12;23(1):150. doi: 10.3390/molecules23010150.
PubMed 29329207Guidelines of the International Conference on Harmonization - Good Clinical Practice: Consolidated Guide (ICH E6), E6(R2) Current Step 4 version dated 9 November 2016
Management of Safety Information from Clinical Trials Report of CIOMS Working Group VI, Geneva 2005, Organizations of Medical Sciences (CIOMS) ISBN 92 9036 079 8
Blum J, Lockwood DN, Visser L, Harms G, Bailey MS, Caumes E, Clerinx J, van Thiel PP, Morizot G, Hatz C, Buffet P. Local or systemic treatment for New World cutaneous leishmaniasis? Re-evaluating the evidence for the risk of mucosal leishmaniasis. Int Health. 2012 Sep;4(3):153-63. doi: 10.1016/j.inhe.2012.06.004.
PubMed 24029394Blum J, Desjeux P, Schwartz E, Beck B, Hatz C. Treatment of cutaneous leishmaniasis among travellers. J Antimicrob Chemother. 2004 Feb;53(2):158-66. doi: 10.1093/jac/dkh058. Epub 2004 Jan 16.
PubMed 14729756Soto J, Rea J, Balderrama M, Toledo J, Soto P, Valda L, Berman JD. Efficacy of miltefosine for Bolivian cutaneous leishmaniasis. Am J Trop Med Hyg. 2008 Feb;78(2):210-1.
PubMed 18256415WHO technical report series; no. 949. Control of the leishmaniasis: report of a meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22-26 March 2010
Silva NS, Muniz VD. [Epidemiology of American tegumentary leishmaniasis in the State of Acre, Brazilian Amazon]. Cad Saude Publica. 2009 Jun;25(6):1325-36. doi: 10.1590/s0102-311x2009000600015. Portuguese.
PubMed 19503963Almeida 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 21738967Tiuman 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 21605997Herwaldt BL. Leishmaniasis. Lancet. 1999 Oct 2;354(9185):1191-9. doi: 10.1016/S0140-6736(98)10178-2.
PubMed 10513726Velez 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 20682881Croft SL, Seifert K, Yardley V. Current scenario of drug development for leishmaniasis. Indian J Med Res. 2006 Mar;123(3):399-410.
PubMed 16778319Pearson, R. D., A. De Queiroz Sousa, and S. M. B. Jeronimo. 2001. Leishmania species: visceral (kala-azar), cutaneous and mucosal leishmaniasis, p. 2831-2845. In G. L. Mandell, J. E. Bennett, and R. Dolin (ed.), Principles and practice of infectious diseases. Churchill Livingstone, New York, N.Y
Votypka 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 22284721
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Safety and Therapeutic Response of Two ARNICA TINCTURE Treatment Regimes in the Topical Treatment of Uncomplicated Cutaneous Leishmaniasis in Colombia
- ClinicalTrials.gov ID
- NCT05094908
- Acronym / sponsor ID
- ARNICA / PEC02_2021
- Conditions
- Leishmaniasis, Cutaneous
- Keywords
- Leishmaniasis, Cutaneous, Arnica tincture
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- INNOVATION CORPORATION FOR THE DEVELOPMENT OF PRODUCTS FOR TROPICAL DISEASES (CIDEPRO)
- Study start
- 3 May 2023 (actual)
- Primary completion
- 2 Nov 2024 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 26 Oct 2021 (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 generally begins with a papule at the sand fly bite site, increasing to form a nodule that progresses to ulceration, or a scaly or wart-like 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 around the world suffer from different forms of CL. In general, most lesions become ulcerated during the course of the disease. Among the different species of the parasite that cause LC, L. tropica from the Old World and L. braziliensis from the New World are considered the most important due to the severity of the disease they produce and because they are more difficult to cure with medications currently available.
Since 2010, the World Health Organization has insisted on the need to work on products that become alternatives for the treatment of CL, especially in products that serve topical application because with them, the probability of systemic toxicity is lower , increasing patient safety.
Among the options for topical treatment are natural products that have been, are, and will be extremely important as sources of medicinal agents. In addition to natural products that have found direct medicinal application 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-echemotic, healing, anti-inflammatory, analgesic and antineuralgic properties; It is included in the Colombian vademecum of medicinal plants. In previous studies it has been observed that the contact of the ulcerated skin with the product for up to 60 days does not generate toxic effects at the local level (application site) or at the systemic level, so it can be considered safe for use. To date there are no human studies with CL.
Therefore, it is intended to evaluate the safety and tolerability of Arnica tincture in individuals with uncomplicated CL, by measuring the occurrence and severity analysis of local and systemic adverse events.
Detailed description
Arnica tincture is a topical preparation based on the plant legally authorized in the countries of the European community, and it is included in the vademecun of medicinal plants in Colombia. The research product is the commercial phytotherapeutic product ARNICA TINTURA Gehrlicher 100 mL manufactured by Gehrlicher Pharmazeutische Extrakte GmbH. (www. https://www.wer-zu-wem.de/firma/gehrlicher-extrakte.html). The product will be imported from Germany through the University of Munster (project co-investigator).
According to the European Pharmacopoeia, the solution is a 70% hydroethanolic tincture prepared from the flowers of Arnica montana L, and composed at least 0.04% of sesquiterpene lactones. Sesquiterpenic lactones (helenalin and 11-α-13 dihydrohelenaline) are the constituents responsible for its anti-inflammatory activity, these molecules decrease inflammation mediated by the transcription factor NF-kB. There are other properties demonstrated in the literature such as antioxidant, antimicrobial or insecticidal activities.
Given the plant's anti-inflammatory, healing, anti-echemotic, analgesic and antineuralgic properties, in a previous study the leishmanicidal activity of arnica tincture was evaluated in vitro for intracellular amastigotes of L. braziliensis and L. tropica. Arnica tincture at a concentration of 4.8 mg / mL produced a decrease in the parasite load (amount of intracellular amastigotes) of 91.9% and 99.6% in cells infected by L. braziliensis and L. tropica, respectively. . The mean maximum Effective Concentrations (EC50) were determined at 2.9 ± 0.13 and 2.7 ± 0.02 respectively, and with selectivity indices> 69 and> 74, for L. braziliensis and L. tropica, respectively. This activity was validated in in vivo studies in hamsters experimentally infected with L. braziliensis. Applying the tincture once a day for 30 days produced a cure of 60 and for the remaining 40% of the hamsters a reduction of more than 80% of the lesions was observed (Robledo et al., 2018). When applied once a day for 60 days, 75% of the hamsters were cured and the remaining 25% showed improvements between 70 and 96% regarding the size of the lesion before treatment. According to the observations made, it is part of the natural evolution of the healing process that, during the first weeks of use of the compound and until the end of the treatment, a flattening of the edges is perceived, with intensification of the erythema, which produces a Optical sensation of enlargement of the lesion, which subsequently (from day 28) gives rise to the re-epithelialization process, which is slightly slower compared to traditional systemic schemes. The percentage of epithelialization of the lesion (s) is calculated by comparing the size of the ulcer at baseline against the size observed at the follow-up visit.
Arnica tincture is not cytotoxic on epithelial cells (Detroit) at any concentrations tested. In liver cells (HepG2) the tincture showed a slight cytotoxicity when evaluated at 100%, with a toxicity percentage of 75%. Weight, clinical appearance, and behavior data, as well as ALT, alkaline phosphatase, creatinine, and urea test results; and the histological studies obtained from the tests in hamsters allowed to conclude that the contact of the ulcerated skin with the product for up to 60 days does not generate toxic effects at the local level (application site) or at the systemic level, so it can be considered as safe for use. Corrosion and irritation tests to evaluate arnica skin tincture according to OECD guidelines suggest that it is neither corrosive nor irritating.
Although it is difficult to calculate accurately, it has been estimated that approximately 2 drops (80uL) of the solution will be used per cm2 in each application. If we consider an average lesion size of 4 cm2, a maximum of 320 uL is used X 3 times a day X 45 or 30 days = 43,200 uL or 28,800uL (equivalent to 43.2 or 28.8 mL) per lesion.
- Main Objectives
- Evaluate the safety and tolerability of Arnica tincture in individuals with uncomplicated CL, by measuring the occurrence and severity analysis of local and systemic ADs.
- Evaluate the therapeutic response of Arnica tincture in individuals with uncomplicated CL, according to the percentage of individuals with initial clinical cure on day 90. Regimen 1: Arnica tincture applied 3 times a day for 30 days (Group 1: 4 weeks) Regimen 2: Arnica tincture applied 3 times a day for 45 days (Group 2: 6 weeks)
- Secondary Objectives
- Evaluate the frequency and severity of AEs associated with the use of the Arnica tincture solution.
- Assess the status of the lesions over time, up to 100% epithelialization of ulcerated lesions and proportion of individuals with 100% epithelialization of non-ulcerated lesions over time.
- Assess the relapse rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open, randomized, non-comparative, exploratory study with two arms. After the informed consent process and the verification of eligibility criteria, the volunteers will be randomly assigned to one of the interventions (30- or 45-day arnica tincture regimen) of the study. All individuals will have a telephone follow-up in the middle of the treatment, in addition, follow-up visits will be made at the end of the therapy, on day 45 post-treatment ± 5 days, on day 60 post-treatment ± 5 days (optional visit), on days 90 post-treatment ± 14 days and 180 days post-treatment-14 + 28 days to evaluate the therapeutic response. The participant will keep a record of the daily application (morning, afternoon and evening) of the study medication to document its application.
| Arm | Type | Receives |
|---|---|---|
| Regime 1 (30 days) | Active comparator | Drug: Arnica TinctureRegimen 1: arnica tincture applied 3 times a day for 30 days (group 1). For both regimens, the participant applies the tincture in the morning, afternoon and evening, that is, three times a day. |
| Regime 2 (45 days) | Active comparator | Drug: Arnica TinctureRegimen 2 arnica tincture applied 3 times a day for 45 days (group 2). For both regimens, the participant applies the tincture in the morning, afternoon and evening, that is, three times a day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or women, of legal age, between 18 and 65 years old.
- With a confirmed parasitological diagnosis of CL in at least one lesion, performed at least through the following methods: 1) microscopic identification of amastigotes in the lesion tissue; 2) diagnosis of leishmania through PCR; 3) positive culture for promastigotes.
- Subjects with an injury that meets the following criteria:
- Subjects with a maximum of 4 LC lesions.
- Injury with an evolution of less than 4 months according to the subject's history.
Key exclusion criteria (9 listed)
- Women with a positive pregnancy test during the screening process, or breastfeeding, or women of childbearing potential who do not accept the use of contraceptives during treatment and up to 45 days after treatment.
- History of clinically significant medical problems or treatments that may interact negatively or positively with topical treatment for Leishmaniasis, including any immunocompromising conditions.
- Within 8 weeks (56 days) of starting the study treatment, having received treatment for Leishmaniasis with any type of medication, including Glucantime that probably, in the opinion of the PI, could modify the course of infection with Leishmania.
- Based on physical examinations performed, a diagnosis of CML has been or is suspected.
- Known or suspected history of hypersensitivity or idiosyncratic reactions to study treatment.
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 or 45, depending on the regimen to be evaluated. | Drug | Regime 1 (30 days), Regime 2 (45 days) |
Primary outcome
Number of participants with Initial post-treatment healing
Time frame: day 90
defined as 100% epithelialization of the lesion (s) by day 90 post-treatment.
2 secondary outcomes
Number of participants with Final post-treatment Healing
Time frame: day 180
Number of participants with lesions that relapse
Time frame: day 180
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 10 Feb 2025.
- Background: PubMed 29329207Robledo SM, Velez ID, Schmidt TJ. Arnica Tincture Cures Cutaneous Leishmaniasis in Golden Hamsters. Molecules. 2018 Jan 12;23(1):150. doi: 10.3390/molecules23010150.
- BackgroundGuidelines of the International Conference on Harmonization - Good Clinical Practice: Consolidated Guide (ICH E6), E6(R2) Current Step 4 version dated 9 November 2016
- BackgroundManagement of Safety Information from Clinical Trials Report of CIOMS Working Group VI, Geneva 2005, Organizations of Medical Sciences (CIOMS) ISBN 92 9036 079 8
- Background: PubMed 24029394Blum J, Lockwood DN, Visser L, Harms G, Bailey MS, Caumes E, Clerinx J, van Thiel PP, Morizot G, Hatz C, Buffet P. Local or systemic treatment for New World cutaneous leishmaniasis? Re-evaluating the evidence for the risk of mucosal leishmaniasis. Int Health. 2012 Sep;4(3):153-63. doi: 10.1016/j.inhe.2012.06.004.
- Background: PubMed 14729756Blum J, Desjeux P, Schwartz E, Beck B, Hatz C. Treatment of cutaneous leishmaniasis among travellers. J Antimicrob Chemother. 2004 Feb;53(2):158-66. doi: 10.1093/jac/dkh058. Epub 2004 Jan 16.
- Background: PubMed 18256415Soto J, Rea J, Balderrama M, Toledo J, Soto P, Valda L, Berman JD. Efficacy of miltefosine for Bolivian cutaneous leishmaniasis. Am J Trop Med Hyg. 2008 Feb;78(2):210-1.
- BackgroundWHO technical report series; no. 949. Control of the leishmaniasis: report of a meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22-26 March 2010
- Background: PubMed 19503963Silva NS, Muniz VD. [Epidemiology of American tegumentary leishmaniasis in the State of Acre, Brazilian Amazon]. Cad Saude Publica. 2009 Jun;25(6):1325-36. doi: 10.1590/s0102-311x2009000600015. Portuguese.
- Background: PubMed 21738967Almeida 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.
- Background: PubMed 21605997Tiuman 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.
- Background: PubMed 10513726Herwaldt BL. Leishmaniasis. Lancet. 1999 Oct 2;354(9185):1191-9. doi: 10.1016/S0140-6736(98)10178-2.
- 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.
- Ministry of Social Protection, 2008. Colombian Vademecum of Medicinal PlantsLink provided by the sponsor.
- Common Terminology Criteria for Adverse Events (CTCAE)Link provided by the sponsor.
- Pan American Health Organization, PAHO. Leishmaniasis in the Americas: Recommendations for treatment. 2013Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Leishmaniasis, Cutaneous
RecruitingObservational study
Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
Recruiting
Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup
Cutaneous Leishmaniasis
Not yet recruiting
Immersive Technology Headsets to Reduce Procedural Pain and Anxiety: Feasibility and Effects in Cutaneous Leishmaniasis Patients in Pakistan
Cutaneous Leishmaniasis, Pain
RecruitingObservational study
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
Leishmaniasis, Cutaneous, Leishmaniasis
Not yet recruitingPhase 2
Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
Cutaneous Leishminiasis
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. This study is not recruiting at the moment.
Ivan D Velez, PhD principal investigator
Director PECET
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Arnica Tincture 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 10 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Initial post-treatment healing (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 NCT05094908, which also lists 24 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 10 Feb 2025.