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Leishmaniasis, Cutaneous clinical trials

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NCT ID: NCT03096457 Completed - Clinical trials for Leishmaniasis, Cutaneous

Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

Start date: April 15, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.

NCT ID: NCT03084952 Not yet recruiting - Drug Side Effect Clinical Trials

Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients

Start date: May 2021
Phase: Phase 2
Study type: Interventional

It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.

NCT ID: NCT03023111 Completed - Clinical trials for Cutaneous Leishmaniasis

Miltefosine and GM-CSF in Cutaneous Leishmaniasis

Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

Cutaneous leishmaniasis (CL) standard treatment is done with parenteral pentavalent antimony (Sbv) at the dose of 15-20mg / kg per day for 20 days. However, therapeutic failure has been described in up to 50% of patients, and the long period of 60 to 90 days required for healing of the ulcerated lesion indicate the need for alternative drugs. Currently the alternatives include other parenteral drugs such as pentamidine and amphotericin B, whose use is limited either by toxicity or because, as with Sbv, the parenteral route hinders adherence and regularity of treatment in the rural area. Recent studies by our group indicate that oral miltefosine is the most effective drug for the treatment of patients with CL caused by L. (V.) guyanensis and L. (V.) braziliensis in Brazil, with a cure rate of 71.4% and 75% respectively. CL pathogenesis is associated with intense inflammatory infiltrate and tissue damage. Previous trials associating GM-CSF to Sbv improved the cure rate of CL caused by L. (V.) braziliensis. The objective of this trial is to evaluate the therapeutic response to the use of miltefosine associated to GM-CSF in the treatment of CL caused by L. (V.) braziliensis in an endemic region in Bahia and Ceará, and by L. (V.) guyanensis in the Amazon region.

NCT ID: NCT02979002 Completed - Clinical trials for Cutaneous Leishmaniasis

Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco

Start date: December 2016
Phase: N/A
Study type: Observational

The aim of this study is to estimate the accuracy of CL Detect Rapid Testâ„¢ compared to a composite reference standard test (Direct examination of skin smears + PCR test) in patients with clinically suspected Cutaneous Leishmaniasis disease in Morocco.

NCT ID: NCT02919605 Completed - Clinical trials for Cutaneous Leishmaniases

Efficacy and Safety of Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis

Start date: January 2014
Phase: Phase 2
Study type: Interventional

Introduction: Up to the present, have been few studies with pentamidine in the Americas; and there is no consensus regarding the dose used. Objectives: To evaluate the use of pentamidine in single dose, double and triplo in the treatment of cutaneous leishmaniasis. Methods: Clinical trial of phase II pilot study with 159 patients. Pentamidine will be used at a dose of 7 mg/kg, in three arms: single dose, double dose and triple dose. They will be also assessed the safety and adverse effects. The sic will be reviewed one, two and six months after the end of the treatments.

NCT ID: NCT02894008 Completed - Clinical trials for Leishmaniasis, Cutaneous

A Study of a New Leishmania Vaccine Candidate ChAd63-KH

Leish2a
Start date: November 2016
Phase: Phase 2
Study type: Interventional

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). This is a Phase II trial in patients with PKDL, to assess the safety and compare the humoral and cellular immune responses generated by the candidate vaccine in patients, and observe any clinical changes in the disease over a 42 day period following vaccination. Study design: Eight adult volunteers will receive 1x10(10)vp and the subsequent eight volunteers will receive 7.5 x10(10)vp. Adolescents will be vaccinated with either 1x10(10)vp or 7.5 x10(10)vp, to be determined by evaluation of all available data after DSMB & CTSC review.

NCT ID: NCT02687971 Completed - Clinical trials for Cutaneous Leishmaniasis

Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨

Start date: December 2016
Phase: Phase 2
Study type: Interventional

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 treatment of uncomplicated CL in Peru and Colombia

NCT ID: NCT02656797 Completed - Leishmaniasis Clinical Trials

Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Start date: January 30, 2018
Phase: Phase 2
Study type: Interventional

Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.

NCT ID: NCT02530697 Active, not recruiting - Leishmaniasis Clinical Trials

The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil

Start date: August 2015
Phase: Phase 2
Study type: Interventional

Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.

NCT ID: NCT02281669 Not yet recruiting - Clinical trials for Cutaneous Leishmaniasis

Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients

Start date: November 2014
Phase: N/A
Study type: Observational

Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local treatment available is intralesional (IL) Pentostam injection. During the current study the investigators will monitor the adverse effects of this treatment and will follow up the recovery of the lesions after Pentostam injections.