A Phase 2/3 interventional study of Paromomycin Sulfate and Pentamidine Isethionate in Leishmaniasis, Cutaneous, Leishmania Braziliensis Complex and Leishmaniasis, American, sponsored by Fundacion Nacional de Dermatologia. Completed at 2 sites in Bolivia. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Fundacion Nacional de Dermatologia · Phase 2/3, Interventional, and Treatment
This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.
Patients will be randomized between Paromomycin cream applied topically once daily for 20 days (group 1--40 patients), pentamidine administered intralesionally at 120 ug/mm2 on days 1, 3, 5 (group 2-20 patients), and cream vehicle applied topically once daily for 20 days (group 3-20 patients).
After treatment, all patients will be followed for 1, 3, and 6 months.
103 studies on the registry are indexed under Leishmaniasis, Cutaneous; 18 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 77 interventional studies indexed under Leishmaniasis, Cutaneous.
Browse Leishmaniasis, Cutaneous studies →Fundacion Nacional de Dermatologia is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
40 subjects will be included to receive 15% paromomycin in aquafilm base twice a day during 20 consecutive days. The lesion will be cleaned , then, a generous amount of the study drug (an amount sufficient to cover the area of the ulcer and the lesion border) will be applied to the lesion and rubbed into the ulcer using a gloved finger by a member of the clinical study staff. After application of the study drug, the patient will be observed for 15 minutes for signs of adverse events. If there are no signs of local toxicity, the area of the ulcer will be covered with extra study drug. For Days 2-20, the study drug will be applied and the lesion covered with a sterile gauze and tape dressing as on Day 1.
Drug: Paromomycin Sulfate
20 subjects will be included to receive IL pentamidine \[Pentacarinat® Sanofi-Aventis: 30 mg/ml\] will administered at a dose of 120 ug (4 ul) per mm2 of lesion area 3 times (on days 1, 3, and 5) as per our previous experience. A small button of Xylocaine® will be applied by means of a thin needle at the four cardinal points of the lesion and then a small gauge (23g) needle will introduce the drug in each cardinal point. The needle will be moved in all directions to infiltrate of whole lesion and surrounding infiltrated area.
Drug: Pentamidine Isethionate
10% Urea en parafilm cream will be used in similar ways as paromomycin cream in group 1
Other: Placebo
topical application 2 times a day during 20 days
3 Intralesional injections at days 1,3 and 5
topical application 2 times a day during 20 days
Change of Lesion size
change of lesion area at 6 months after treatment compared to baseline
Time frame: 6 months
Number of participants with treated-related adverse events
Adverse events will measured according to CTCAE 4.03
Time frame: 1 month
Plan to share: No
Ran from Apr 2017 to primary completion in Mar 2018, 11 months.
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Paromomycin
Fundacion Nacional de Dermatologia