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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 February 2021 |
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Main ID: |
NCT03096457 |
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Date of registration:
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09/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia
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Scientific title:
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Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study |
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Date of first enrolment:
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April 15, 2017 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03096457 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Bolivia
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Contacts
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Name:
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JAIME SOTO, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundacion Nacional de Dermatologia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Gender: Male or female
- Age: >12 yrs of age
- Presentation: 1-to-2 ulcerative lesions, each < 30 mm in largest diameter and with a
total lesion area <900 mm2.
- Parasitology: Parasitological confirmation of the lesion will be made by visualization
or culture of Leishmania from the biopsy or aspirate of the lesion.
Exclusion Criteria:
- Previous treatment for leishmaniasis with Sb, pentamidine, amphotericin B,
miltefosine, imidazoles, allopurinol in the last 3 months.
- Other diseases that would be likely in the PI's opinion to interact, either positively
or negatively, with treatment.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Leishmania Braziliensis Complex
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Leishmaniasis; American, Cutaneous
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Leishmaniasis, American
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Leishmaniasis, Cutaneous
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Intervention(s)
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Other: Placebo
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Drug: Paromomycin Sulfate
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Drug: Pentamidine Isethionate
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Primary Outcome(s)
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Change of Lesion size
[Time Frame: 6 months]
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Secondary Outcome(s)
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Number of participants with treated-related adverse events
[Time Frame: 1 month]
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Secondary ID(s)
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ABF-BO-2016-102
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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