Clinical trials: Cutaneous Leishmaniasis
PKDL - Post-Kala-Azar Dermal Leishmanioid
Short Course Regimens for Treatment of PKDL (Sudan)
This is an open label, randomized non comparative phase II clinical trial conducted on parallel groups, to assess the safety and efficacy of the combination of Paromomycin (20 mg/kg/d) IM for 14 days and Miltefosine (allometric…
- Trial name
- NCT03399955
- Testing
- Paromomycin, Ambisome, Miltefosine
- Where
- Sudan
- Volunteers
- 110 people
- Sponsor
- Drugs for Neglected Diseases
Cutaneous Leishmaniasis
Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony…
- Trial name
- GMCSFSbv (NCT00973128)
- Testing
- GMCSF plus Antimony reduced dose, Meglumine antimoniate
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- Hospital Universitário Professor Edgard Santos
Cutaneous Leishmaniasis
Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis
Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable.
- Trial name
- HECT (NCT01277796)
- Testing
- Heat pack conduction-heat therapy
- Sponsor
- Universidad Peruana Cayetano Heredia
Post Kala Azar Dermal Leishmaniasis
Safety and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine With SSG for Patients With PKDL
A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of three injections of 10 µg LEISH-F2 + 25 µg MPL-SE given at 14-day intervals as an adjunct to standard…
- Trial name
- NCT00982774
- Testing
- LEISH-F2 + MPL-SE vaccine
- Where
- Sudan
- Volunteers
- 42 people
- Sponsor
- Access to Advanced Health Institute (AAHI)
Leishmaniasis, Cutaneous
Intralesional Voriconazole, or Intralesional Cryotherapy, or Oral Doxycycline in the Treatment of Cutaneous Leishmaniasis
Leishmaniasis is a vector-borne disease caused by obligate, intracellular protozoa of the genus Leishmania and transmitted by phlebotomine sandflies.
- Trial name
- NCT05708625
- Testing
- Intralesional Sodium stibogluconate, Intralesional Cryotherapy, Intralesional Voriconazole
- Where
- Libya
- Volunteers
- 136 people
- Sponsor
- Zagazig University
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
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
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
Post-kala-azar Dermal Leishmaniasis
A Study to Assess Safety and Efficacy of a Leishmania Vaccine to Prevent Post Kala Azar Dermal Leishmaniasis (PKDL)
The actual format of the anticipated LEISH3 trial is under review.
- Trial name
- LEISH3 (NCT04107961)
- Testing
- Vaccine
- Sponsor
- University of York
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
Cutaneous Leishmaniases
Effectiveness, Safety and Feasibility of HECT-CL, in Quetta, Pakistan
This research studies the effect thermotherapy as treatment of Old World CL which is not invasive, non-toxic, and the short treatment. While the current standard treatment comprise daily painful injections with antimonials,
- Trial name
- HECT-CL (NCT03208543)
- Testing
- HECT-CL
- Where
- Pakistan
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Medecins Sans Frontieres, Netherlands
Cutaneous Leishmaniases
Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium
Cutaneous Leishmaniasis (CL) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries.
- Trial name
- RapidLeish (NCT04001335)
- Testing
- Dental Broach
- Where
- Belgium
- Volunteers
- 6 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Cutaneous Leishmaniasis
Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis.
- Trial name
- Lowdosesb (NCT00317980)
- Testing
- Meglumine antimoniate
- Where
- Brazil
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- University of Brasilia
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
Healthy
Safety/Efficacy Trial of Killed Leishmania Vaccine in Volunteers With no Response to Leishmanin
Development of a safe and effective vaccine against leishmaniasis started more than 10 years ago under WHO/TDR supervision. An autoclaved L. major vaccine (ALM) mixed with BCG has been tested in human in Iran, Pakistan and Sudan.
- Trial name
- NCT00429715
- Testing
- Alum-ALM + BCG
- Where
- Iran
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Tehran University of Medical Sciences
Mucosal Leishmaniasis, Mucocutaneous Leishmaniasis
Low Antimonial Dosage in American Mucosal Leishmaniasis
"Phase III clinical trial for mucosal or mucocutaneous leishmaniasis. Equivalence between the standard and alternative schemes with meglumine antimoniate" has begun in October 2008 at the Laboratory of Leishmaniasis Surveillance…
- Trial name
- NCT01301937
- Testing
- Meglumine antimoniate
- Where
- Brazil
- Volunteers
- 76 people
- Sponsor
- Oswaldo Cruz Foundation
Cutaneous Leishmaniasis
WR 279,396 for the Treatment of Cutaneous Leishmaniasis
The objectives of the study are to evaluate the safety and efficacy of open label treatment with WR 279,396 (topical paromomycin \& gentamicin) in patients with non-complicated, non-severe cutaneous leishmaniasis (CL).
- Trial name
- PAGELEC (NCT01988909)
- Testing
- WR 279,396
- Where
- 2 sites in France
- Volunteers
- 18 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis.
- Trial name
- NCT00257530
- Testing
- Imiquimod
- Where
- 2 sites in Peru
- Volunteers
- 80 people
- Sponsor
- Drugs for Neglected Diseases
Healthy
Safety/Efficacy Trial of Killed Leishmania Vaccine in Volunteers With Positive Response to Leishmanin (LST>0)
Development of a safe and effective vaccine against leishmaniasis started more than 10 years ago under WHO/TDR supervision. An autoclaved L. major vaccine (ALM) mixed with BCG has been tested in human in Iran, Pakistan and Sudan.
- Trial name
- NCT00429780
- Testing
- Alum-ALM + BCG
- Where
- Iran
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Tehran University of Medical Sciences