A Phase 1/2 interventional study of Sm29 Protein, Schistosoma Mansoni and Pentavalent antimony (Sbv) in Cutaneous Leishmaniasis, American, sponsored by Hospital Universitário Professor Edgard Santos. Completed at 1 site in Brazil. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Hospital Universitário Professor Edgard Santos · Phase 1/2, Interventional, and Treatment
This project is composed of a phase I study with the purpose of evaluating adverse reactions and the best dose to be used of Sm29 and a phase II randomized controlled study with 3 arms with the purpose of comparing the efficacy of meglumine antimoniate associated with Sm29, with meglumine antimoniate plus placebo and meglumine antimoniate alone in the treatment of cutaneous leishmaniasis.
The phase I study was performed in 10 healthy subjects and 10 patients with CL. In healthy individuals (N=5) Sm29 was applied to healthy skin at a concentration of 5ug and in another 5 Sm29 was used at a dose of 10ug applied twice a day for 20 days. A phase I study was also carried out in 10 patients with CL to assess the occurrence of adverse reactions to Sm29 applied to the ulcerated lesion and to compare the use of two doses of Sm29. In 5 patients, Sm29 was used at a dose of 5ug and applied twice a day, and in 10 patients, a dose of 10ug of Sm29 was used, also applied twice a day. The 10 patients were also treated with glucantime at a dose of 20mg/kg/weight with a maximum dose of 1200mg/day intravenously for 20 days. Patients were evaluated on days 10, 20 and 30 for adverse reactions.
21 studies on the registry are indexed under Leishmaniasis, Mucocutaneous; 7 are open to participants now.
This study's enrollment of 20 is below the median of 49 across 16 interventional studies indexed under Leishmaniasis, Mucocutaneous.
Browse Leishmaniasis, Mucocutaneous studies →Hospital Universitário Professor Edgard Santos is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of topical Sm29 twice a day during 20 days and systemic Sbv during 20 days
Drug: Sm29 Protein, Schistosoma Mansoni · Drug: Pentavalent antimony (Sbv)
Use of topical placebo twice a day during 20 days and systemic Sbv during 20 days
Drug: Pentavalent antimony (Sbv)
Sm29 cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.
Also known as: Pentavalent antimony (Sbv)
Placebo cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.
Also known as: Placebo cream
Cure
Complete re epithelization of the ulcer(s), without any area of ulceration and without raised or infiltrated borders.
Time frame: 90 days
Plan to share: No — Not to be shared.
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Apr 2022, 38 months.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Leishmaniasis, Mucocutaneous →
Hospital Universitário Professor Edgard Santos