Clinical trials: Cutaneous Leishmaniases
Post Kala Azar Dermal Leishmaniasis
Miltefosine for Children With PKDL
Hypothesis: Primary hypothesis: 1. Oral treatment with Miltefosine in children with PKDL at allometric daily dose (based on body weight and height) for 12 weeks is safe with a cure rate of ≥95%. Secondary hypothesis: 2.
- Trial name
- NCT02193022
- Testing
- Miltefosine
- Where
- Bangladesh
- Volunteers
- 80 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Cutaneous Leishmaniasis
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L braziliensis in Bolivia and cutaneous leishmaniasis…
- Trial name
- NCT00233545
- Testing
- miltefosine, antimony
- Where
- Bolivia
- Volunteers
- 80 people
- Sponsor
- AB Foundation
Skin Diseases
Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amastigotes in a stained lesion…
- Trial name
- NCT01865032
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- U.S. Army Medical Research and Development Command
Cutaneous Leishmaniasis
Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
"Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis " has begun in October 2008 at the Laboratory of…
- Trial name
- NCT01301924
- Testing
- Meglumine antimoniate
- Where
- Brazil
- Volunteers
- 72 people
- Sponsor
- Oswaldo Cruz Foundation
Localized Cutaneous Leishmaniasis
A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).
The purpose of this clinical trial is to measure efficacy, safety and pharmacokinetics (PK) of two LXE408 oral regimens and oral miltefosine tablets as active control in localized cutaneous leishmaniasis in the region of the…
- Trial name
- NCT06997159
- Testing
- LXE408, Miltefosine 50 MG Oral Capsule [Impavido]
- Where
- 5 sites in Brazil, Panama
- Volunteers
- 250 people
- Sponsor
- Drugs for Neglected Diseases
Leishmaniasis, Cutaneous
Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis
Cutaneous Leishmaniasis (CL) is a parasitic disease caused by more than 20 different species of the protozoan parasite Leishmania.
- Trial name
- ARNICA (NCT05094908)
- Testing
- Arnica Tincture
- Where
- Colombia
- Volunteers
- 16 people
- Sponsor
- Universidad de Antioquia
Cutaneous Leishmaniasis
Epidemiology of Cutaneous Leishmaniasis in Niger, Mali, Togo : Mapping of Clinical Cases, Species, Reservoirs and Vectors of the Disease
Cutaneous leishmaniasis is a neglected tropical disease caused by parasites belonging to the genus Leishmania. This infection can cause skin and sometimes mucous membrane lesions with significant damage.
- Trial name
- LEISHAFRICA (NCT06692985)
- Testing
- Clinical and epidemiological data, Parasitological samples, Assessment of clinical course and response to treatment
- Where
- 3 sites in Mali, Niger and 1 more
- Volunteers
- 270 people
- Sponsor
- Centre Hospitalier de Cayenne
Leishmaniasis, Cutaneous
ASYMPTOMATIC CARRIER OF LEISHMANIA INFANTUM, MEDISERRANEAN VISCERAL LEISHMANIOSIS AGENT: STUDY OF IMMUNE RESPONSE -
Leishmaniasis is considered by the WHO as emerging and uncontrolled diseases. They are the second leading cause of death and the fourth leading cause of morbidity in tropical diseases.
- Trial name
- Asymptoleish (NCT03303898)
- Testing
- Blood sampling
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Nice
Cutaneous Leishmaniasis
Safety Study to Evaluate the Leish-111f + MPL-SE Vaccine in the Prevention of Cutaneous Leishmaniasis in Healthy Subjects Previously Exposed to the Leishmania Parasite
This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with a previous exposure to the Leishmania parasite (but without current or past history of leishmaniasis).
- Trial name
- NCT00121849
- Testing
- Leish-111f + MPL-SE vaccine
- Where
- Colombia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Cutaneous Leishmaniasis
Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
The purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by…
- Trial name
- NCT00487253
- Testing
- Miltefosine, Meglumine antimoniate
- Volunteers
- 150 people
- Sponsor
- Centro Internacional de Entrenamiento e Investigaciones Médicas
Leishmaniasis, Cutaneous
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis
This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with cutaneous leishmaniasis.
- Trial name
- NCT00111553
- Testing
- Leish-111f + MPL-SE vaccine
- Where
- 2 sites in Brazil
- Volunteers
- 45 people
- Sponsor
- Access to Advanced Health Institute (AAHI)
Cutaneous Leishmaniasis
Documentation of Patient Outcomes for SSG/Allopurinol Combination Treatment in Ethiopia
Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is.
- Trial name
- NCT04699383
- Testing
- Sodium Stibogluconate with allopurinol
- Where
- Ethiopia
- Volunteers
- 105 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Cutaneous Leishmaniasis
Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
Anthroponotic Cutaneous Leishmaniasis (ACL) is a parasitic disease caused by Leishmania tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for leishmaniasis…
- Trial name
- NCT04340128
- Testing
- Meglumine antimoniate
- Where
- Iran
- Sponsor
- Tehran University of Medical Sciences
Mucosal Leishmaniasis, Cutaneous Leishmaniasis
Miltefosine to Treat Mucocutaneous Leishmaniasis
The purpose of this Treatment Investigational New Drug application was to make miltefosine available for mucocutaneous leishmaniasis patients presenting in the United States.
- Trial name
- NCT01050907
- Testing
- Miltefosine
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Knight Therapeutics (USA) Inc
Cutaneous Leishmaniases
Spatial Analysis of Host-parasite Interactions in Cutaneous Leishmaniasis in Ethiopia
Cutaneous leishmaniasis manifestations range from self-healing localized skin ulcers/nodules to diffusely spread chronic lesions.
- Trial name
- SpatialCL (NCT05332093)
- Testing
- skin biopsy, venous blood sample (plasma, PBMC, WB), venous blood sample (HLA)
- Where
- Ethiopia
- Volunteers
- 92 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Cutaneous Leishmaniasis, American
Feasibility and Usability of Mobile Applications for Monitoring Cutaneous Leishmaniasis Treatment in Colombia
An effectiveness-implementation sequential explanatory hybrid design type 2 was performed in two rural communities of Colombia. A quasi-experimental study with historical control (standard of care) was designed to estimate the…
- Trial name
- NCT05533736
- Testing
- Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis
- Where
- Colombia
- Volunteers
- 105 people
- Sponsor
- Centro Internacional de Entrenamiento e Investigaciones Médicas
Post Kala Azar Dermal Leishmaniasis
Ivermectin Repurposed for the Treatment of PKDL
Background (brief): 1. Burden: Post-Kala-Azar Dermal Leishmaniasis (PKDL) commonly follows visceral leishmaniasis (VL) caused by Leishmania donovani.
- Trial name
- NCT07286604
- Testing
- Ivermectin 6 MG Oral Tablet (2 tablets)
- Where
- Bangladesh
- Volunteers
- 10 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Cutaneous Leishmaniasis
Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis
Cutaneous leishmaniasis is endemic in the New World from approximately the US-Mexican border through Central America and the Northern part of South America down to the level of Rio de Janeiro.
- Trial name
- NCT01380314
- Testing
- Miltefosine + Imiquimod
- Where
- Bolivia
- Volunteers
- 60 people
- Sponsor
- Foundation Fader
Cutaneous Leishmaniasis, American
Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis
Cure rate for L braziliensis bolivian CL has been 70%-80% for standard systemic and local monotherapies. It would benefit patients if cure rates could be consistently >90%, so testing a combination of two treatments is proposed.
- Trial name
- NCT03829917
- Testing
- Miltefosine and Paromomycin, miltefosine, paromomycin
- Where
- Bolivia
- Volunteers
- 120 people
- Sponsor
- Fundacion Nacional de Dermatologia
Localized Cutaneous Leishmaniasis
Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients
This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years.
- Trial name
- Sbold (NCT00818818)
- Testing
- Meglumine antimoniate
- Where
- Brazil
- Volunteers
- 13 people
- Sponsor
- University of Brasilia