Cutaneous Leishmaniasis Clinical Trial
— GTOfficial title:
Therapeutic Gain of Adding the Immunomodulator Pentoxifylline to the Treatment of Cutaneous Leishmaniasis
The purpose of this study is to determine whether adding pentoxifylline to treatment of American cutaneous leishmaniasis with meglumine antimoniate increases the rate and speed of clinical response without diminishing safety, and to identify immune correlates of the healing response.
Status | Completed |
Enrollment | 75 |
Est. completion date | December 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with clinical diagnosis of cutaneous leishmaniasis (parasitologic confirmation or presumptive biopsy plus a positive Montenegro skin test). - Age between 18 and 65 years. - Lesions of a duration equal to or greater than one month - More than one lesion or single lesion greater than 3 cm in diameter. - Willingness to participate in the study after being informed through a consent process approved by the institutional ethical review committee Exclusion Criteria: - Pregnant or lactating women, and women who are planning to conceive during the study or that reject the use of birth control methods. - Medical conditions that compromise the immune system (HIV infection, neoplasias, diabetes mellitus, autoimmune diseases, or use of corticosteroids, immunomodulators or antineoplastic drugs). - Medical conditions that preclude the use of antimonials or pentoxifylline (cardiac, renal, hepatic or pancreatic disease or abnormalities). - Alcohol abuse or use of recreational drugs that interfere with adherence to treatment - Use of drugs with antileishmanial potential during the previous 13 weeks, including pentavalent antimonials, amphotericin B, miltefosine, and pentamidine - Use of Theophylline , anticoagulants or antiarrhythmics. - Diffuse or disseminated leishmaniasis. - Mucosal involvement secondary to Leishmania infection. - Incapacity to attend the study visits or any other condition that according to the investigator could interfere with adherence to study procedures. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Colombia | Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas | Cali | Valle |
Lead Sponsor | Collaborator |
---|---|
Centro Internacional de Entrenamiento e Investigaciones Médicas |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary efficacy outcome: Definitive Cure | Definitive cure, defined as complete re-epithelialization and absence of inflammatory signs in all cutaneous leishmaniasis lesions, and absence of new leishmaniasis lesions | Participants will be followed up to 26 weeks | No |
Primary | Primary safety outcome: Adverse Events | Clinical and laboratory adverse events will be qualified according to the Common Toxicity Criteria for Adverse Effects (CTCAE). All unexpected non serious adverse events will be notified and expected adverse events of moderate or higher category will be reported. All serious adverse events will be reported. | Participants will be followed up to 26 weeks | Yes |
Secondary | In vitro lymphoproliferation | Proliferation of peripheral blood mononuclear cells (PBMCs) after stimulation invitro with L. panamensis antigens will be measured by tritiated thymidine uptake | Participants will be followed for an average of 20 days | No |
Secondary | Cytokine secretion by PBMCs | Secretion of a panel of cytokines relevant to the inflammatory and immune responses will be measured in supernatants from PBMCs cultured with L. panamensis antigens using Luminex technology | Participants will be followed for an average of 20 days | No |
Secondary | Macrophage leishmanicidal capacity | Macrophages will be differentiated from peripheral blood monocytes and their leishmanicidal capacity will be measured by luminometry after infecton with luciferase-transfected promastigotes. | Participants will be followed for an average of 20 days | No |
Secondary | Macrophage inducible nitric oxide synthase (iNOS) expression | Macrophage expression of iNOS after infection will be measured by quantitative real-time Polymerase Chain Reaction (RT-PCR). | Participants will be followed for an average of 20 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01988909 -
WR 279,396 for the Treatment of Cutaneous Leishmaniasis
|
Phase 2 | |
Enrolling by invitation |
NCT00840359 -
Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis
|
Phase 2 | |
Enrolling by invitation |
NCT00737386 -
Frequency of Parasite Infection in Hyraxes and Sandflies During Outbreak of Leishmania Tropica Epidemic in The West Bank
|
N/A | |
Completed |
NCT00233545 -
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
|
Phase 2 | |
Completed |
NCT01462500 -
Pharmacokinetics of Miltefosine in Children and Adults
|
Phase 4 | |
Completed |
NCT01011309 -
A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
|
Phase 2 | |
Completed |
NCT01301924 -
Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT02281669 -
Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients
|
N/A | |
Completed |
NCT01790659 -
Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama
|
Phase 3 | |
Completed |
NCT01050907 -
Miltefosine to Treat Mucocutaneous Leishmaniasis
|
Phase 2 | |
Completed |
NCT04340128 -
Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
|
Phase 3 | |
Completed |
NCT00351520 -
Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica
|
Phase 3 | |
Terminated |
NCT00317629 -
Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis
|
Phase 3 | |
Completed |
NCT01381055 -
Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis
|
Phase 2/Phase 3 | |
Completed |
NCT01050777 -
Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis
|
Phase 0 | |
Completed |
NCT01380314 -
Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis
|
Phase 2 | |
Terminated |
NCT01380301 -
Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony
|
Phase 2 | |
Completed |
NCT00703924 -
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
|
Phase 2 | |
Completed |
NCT00344084 -
Surveillance for Leishmaniasis Skin Lesions in Mali
|
||
Completed |
NCT03023111 -
Miltefosine and GM-CSF in Cutaneous Leishmaniasis
|
Phase 3 |