Clinical trials: Cutaneous Leishmaniasis
Cutaneous Leishmaniases
OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
While there are indications that 28 days of miltefosine is not sufficient for treating CL by L. aethiopica, a better understanding of what happens in terms of parasite clearance and drug dosing is lacking.
- Trial name
- OPTIMILEISH (NCT06514560)
- Testing
- Miltefosine
- Where
- Ethiopia
- Volunteers
- 80 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Cutaneous Leishmaniasis
Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨
The purpose of this trial is to determine the efficacy and safety of a combined therapy using thermotherapy (TT) (one session, 50 degrees Celsius for 30") + miltefosine at a standard dose of 2.5 mg/kg/day for 21 days for the…
- Trial name
- NCT02687971
- Testing
- Miltefosine
- Where
- 2 sites in Colombia, Peru
- Volunteers
- 130 people
- Sponsor
- Drugs for Neglected Diseases
Kinetoplastid, Skin Diseases, Parasitic
Diagnosis and Treatment of Leishmania Infections
Patients admitted on this protocol must have an active Leishmania infection. The major objectives of the protocol are to diagnose and classify the Leishmania infection and to provide species-based therapy to study the natural…
- Conditions
- Kinetoplastid, Skin Diseases, Parasitic, Parasitic Diseases, Leishmaniasis
- Trial name
- NCT00344188
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Leishmaniasis, Cutaneous
Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK)
The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).
- Trial name
- NCT01032382
- Testing
- WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream), Paromomycin Alone Cream (15% paromomycin topical cream)
- Where
- Peru
- Volunteers
- 30 people
- Sponsor
- U.S. Army Medical Research and Development Command
Leishmaniasis, Cutaneous
A Study of a New Leishmania Vaccine Candidate ChAd63-KH
This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in patients with persistent post kala azar dermal leishmaniasis (PKDL).
- Trial name
- Leish2a (NCT02894008)
- Testing
- ChAd63-KH
- Where
- Sudan
- Volunteers
- 24 people
- Sponsor
- University of York
Cutaneous Leishmaniases
Complex Cutaneous Leishmaniasis Healing Study in Algeria
This study evaluates the effect of clean wound management and dressing on complex zoonotic cutaneous leishmaniasis caused by L. major in the MENA region (Algeria). The patients will participate in the wound dressing themselves.
- Trial name
- LeiClean (NCT03292835)
- Testing
- LeiProtect®
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- K. W. Stahl
Cutaneous Leishmaniasis
WR 279,396 Open Label Treatment Protocol in Tunisia
The U.S. Army has recently completed a Phase 3 clinical trial in Tunisia. This is an open-label single site trial designed to expand our safety database and capture additional efficacy (final clinical cure rate of an index…
- Trial name
- NCT01494350
- Testing
- WR 279,396 topical cream
- Where
- Tunisia
- Volunteers
- 50 people
- Sponsor
- U.S. Army Medical Research and Development Command
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
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)
Leishmaniasis, Cutaneous, Vector Borne Diseases
Enhancing Protection Against Vector-borne Diseases in Forcibly Displaced Communities: Evaluating the Efficacy of Spatial Repellents for Cutaneous Leishmaniasis Control in North-East Syria
The aim of this study is to determine the efficacy of Mosquito Shield (spatial repellent) in reducing cutaneous leishmaniasis case incidence among internally displaced persons and sandfly density in temporary shelters and camp…
- Trial name
- NCT06917040
- Testing
- Spatial repellant emanator
- Where
- Syria
- Volunteers
- 18,404 people, healthy volunteers welcome
- Sponsor
- The Mentor Initiative
Cutaneous Leishmaniasis
Surveillance for Leishmaniasis Skin Lesions in Mali
This study will examine why some people who become infected with the leishmaniasis parasite develop skin lesions and others do not. The parasite that causes leishmaniasis is transmitted by the bite of a sandfly.
- Trial name
- NCT00344084
- Where
- Mali
- Volunteers
- 1,593 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cutaneous Leishmaniasis
Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis
The aim of the project is to determine whether daylight activated photodynamic therapy is effective in treating cutaneous leishmaniasis caused by L. major and L. tropical.
- Trial name
- NCT00840359
- Testing
- Photodynamic therapy, Cryotherapy
- Where
- Israel
- Volunteers
- 44 people
- Sponsor
- Hadassah Medical Organization
Cutaneous Leishmaniasis
Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.
Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000 new cases of CL were diagnosed in Colombia.
- Trial name
- NCT00471705
- Testing
- Miltefosine, Thermotherapy, Glucantime®
- Where
- Colombia
- Volunteers
- 437 people
- Sponsor
- Universidad de Antioquia
Old World Cutaneous Leishmaniasis
Randomised Clinical Trial in Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan
A four (4) -arm randomised control clinical trial to evaluate miltefosine, thermotherapy and the combination miltefosine-thermotherapy are effective, safe and tolerable alternative treatment options to treat cutaneous…
- Trial name
- NCT04268524
- Testing
- drug: miltefosine with thermotherapy
- Where
- 3 sites in Pakistan
- Volunteers
- 645 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Leishmaniasis
Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis
Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.
- Trial name
- NCT02656797
- Testing
- Topical Amphotericin-B 0.4% liposomal gel
- Where
- Israel
- Volunteers
- 13 people
- Sponsor
- Soroka University Medical Center
Leishmaniasis, Cutaneous
Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru
Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test in Peru, using a test procedure that was modified from that described in the device instructions to optimize these parameters for the detection of…
- Trial name
- NCT03762070
- Testing
- CL Detect™ Rapid Test
- Where
- 2 sites in Peru
- Volunteers
- 200 people
- Sponsor
- Naval Medical Research Center
Cutaneous Leishmaniasis
Topical 3% Amphotericin B Cream for the Treatment of Cutaneous Leishmaniasis in Colombia
The proposed study encompasses a two-step approach. The first aiming to determine the safety of Topical 3% Amphotericin B Cream when applied three or two times per day for 4 weeks in subjects with un-complicated Cutaneous…
- Trial name
- Anfoleish (NCT01845727)
- Testing
- Topical Amphotericin B at 3%
- Where
- Colombia
- Volunteers
- 80 people
- Sponsor
- Drugs for Neglected Diseases
Cutaneous Leishmaniasis, American
Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis
Phase 2/3 randomized and controlled clinical trial, which will evaluate the effectiveness of the association meglumine antimoniate (Glucantime) with tofacitinib in the cure of CL and the capacity of this association to reduce the…
- Trial name
- CLTofa23 (NCT06011343)
- Testing
- Oral tofacitinib, Parenteral meglumine antimoniate
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- Hospital Universitário Professor Edgard Santos
Cutaneous Leishmaniasis
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of LtSTA.
- Trial name
- NCT00633009
- Testing
- Leishmania tropica Skin Test Antigen (LtSTA)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Nielsen BioSciences, Inc.
Wound Healing
Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients
The rationales of a clinical trial comparing intralesional antimonial therapy versus wound care management in patients with old world cutaneous leishmaniasis (OWCL) are the following: 1.
- Trial name
- LEICO (NCT00996463)
- Testing
- Electro-thermo-coagulation, Sodium Stibogluconate, DAC N-055
- Where
- Afghanistan
- Volunteers
- 63 people
- Sponsor
- Waisenmedizin e. V. Promoting Access to Essential Medicine