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Leishmaniasis, Cutaneous clinical trials

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NCT ID: NCT00818818 Completed - Clinical trials for Localized Cutaneous Leishmaniasis

Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients

Sbold
Start date: August 2008
Phase: Phase 4
Study type: Interventional

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. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.

NCT ID: NCT00737386 Enrolling by invitation - Clinical trials for Cutaneous Leishmaniasis

Frequency of Parasite Infection in Hyraxes and Sandflies During Outbreak of Leishmania Tropica Epidemic in The West Bank

Start date: September 2009
Phase: N/A
Study type: Observational

The objective of the project is to study the pathogenesis of Leishmania tropica infection in a focus of infection, to learn about relationship of infection in humans with ecological factors such as infection in hyraxes reservoir hosts and vector sandflies

NCT ID: NCT00703924 Completed - Clinical trials for Cutaneous Leishmaniasis

Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World

Start date: March 2003
Phase: Phase 2
Study type: Interventional

The objective of this study is to determine the effectiveness and toxicity of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.

NCT ID: NCT00682656 Terminated - Clinical trials for Cutaneous Leishmaniasis

Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis

PCL01
Start date: June 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The adequate treatment of the American tegumentary leishmaniasis is crucial since the disease, differently from the caused by the Old World species, is painful and not self-healing and may lead to the disfiguring mucosal involvement. So far, pentavalent antimony compounds have been considered the treatment of choice for cutaneous leishmaniasis (CL), however, these drugs present high frequency of side effects and important disadvantages as parenteral administration and need for careful renal and cardiac monitoring. Azithromycin is a macrolide antibiotic, non-expensive, largely commercially available that has shown in-vitro and in vivo activity against different species of Leishmania. The main objective of this study is to evaluate the efficacy and safety of oral azithromycin for the treatment of CL. The efficacy of oral treatment of azithromycin 500 mg/day for 20 days is going to be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (Glucantime®) for 20 days in patients with CL from two endemic regions of Brazil: the metropolitan region of Belo Horizonte and Montes Claros (MG)in the southeast Brazil and in Corte de Pedras (Bahia), Northeastern Brazil. The patients follow up lasts for 12 months.

NCT ID: NCT00657917 Terminated - Clinical trials for Cutaneous Leishmaniasis

Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396

Start date: December 20, 2006
Phase: Phase 2
Study type: Interventional

The primary objective of this protocol is to treat laboratory confirmed cutaneous leishmaniasis with WR 279,396 in military health care beneficiaries. In this study "cutaneous leishmaniasis" is defined as Old World Leishmaniasis if acquired in the Southwest Central Asia/Middle East.

NCT ID: NCT00633009 Completed - Clinical trials for Cutaneous Leishmaniasis

Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen

Start date: August 2008
Phase: Phase 2
Study type: Interventional

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. The measurements of non-specific reactivity due to components of the antigen solution and the product's ability to sensitize lymphocytes of Leishmania naïve persons when administered intradermally. The presence or absence of a local inflammatory response to the first skin test with each of three doses of LtSTA will provide insight on the specificity of the antigen in a naïve population. The local inflammatory response to LtSTA following the first and second repeat skin tests will indicate if the antigen is sensitizing after intradermal administration.

NCT ID: NCT00606580 Completed - Clinical trials for Cutaneous Leishmaniasis

Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)

Start date: January 2008
Phase: Phase 3
Study type: Interventional

This study will test the ability of the topical cream WR 279,396 to treat the skin lesions caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin + gentamicin. This cream will be compared to the effect of a topical cream containing paromomycin alone and to a placebo cream that contains no antibiotics. Therefore, this study will have three groups of patients, and they will be assigned to one of these treatments randomly. The study will be carried out without the patient or the physician knowing which cream is being used for which patient. The goal is to determine if WR 279,396 cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than paromomycin alone.

NCT ID: NCT00600548 Completed - Clinical trials for Treatment of Cutaneous Leishmaniasis in Brazil.

Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

Start date: July 2007
Phase: Phase 2
Study type: Interventional

The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).

NCT ID: NCT00537953 Recruiting - Clinical trials for Cutaneous Leihmaniasis

Short Course of Miltefosine and Antimony to Treat Cutaneous Leishmaniasis in Bolivia

Start date: n/a
Phase: Phase 2
Study type: Interventional

The combination of a half-course of miltefosine and a half-course of antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and antimony is chosen because these are now the two standard agents in Bolivia, and in vitro the combination was additive to mildly synergistic against a standard leishmania strain.

NCT ID: NCT00508963 No longer available - Clinical trials for Leishmaniasis, Cutaneous

Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis

Start date: n/a
Phase:
Study type: Expanded Access

Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be treated with sodium stibogluconate (Pentostam).