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Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

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ClinicalTrials.gov Identifier: NCT03096457
Recruitment Status : Completed
First Posted : March 30, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Fundacion Nacional de Dermatologia

Brief Summary:
This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.

Condition or disease Intervention/treatment Phase
Leishmaniasis, Cutaneous Leishmania Braziliensis Complex Leishmaniasis, American Leishmaniasis; American, Cutaneous Drug: Paromomycin Sulfate Drug: Pentamidine Isethionate Other: Placebo Phase 2 Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Double (Participant, Investigator)
Masking Description: Group 1 (Paromomycin cream) will be compared to Group 3 (Vehicle cream). Both creams will have very similar physical characteristics and package. Group 2 (intralesional injection of pentamidine) will not be masked.
Primary Purpose: Treatment
Official Title: Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study
Actual Study Start Date : April 15, 2017
Actual Primary Completion Date : March 18, 2018
Actual Study Completion Date : April 1, 2018


Arm Intervention/treatment
Experimental: Group 1 - Paromomycin cream
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
topical application 2 times a day during 20 days

Active Comparator: Group 2. Local Injectable Pentamidine

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
3 Intralesional injections at days 1,3 and 5

Placebo Comparator: Group 3. Vehicle control
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




Primary Outcome Measures :
  1. Change of Lesion size [ Time Frame: 6 months ]
    change of lesion area at 6 months after treatment compared to baseline


Secondary Outcome Measures :
  1. Number of participants with treated-related adverse events [ Time Frame: 1 month ]
    Adverse events will measured according to CTCAE 4.03



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096457


Locations
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Bolivia
Hospital Local Palos Blancos
Palos Blancos, La Paz, Bolivia, 00000
Hospital Dermatologico de Jorochito
Jorochito, SC, Bolivia
Sponsors and Collaborators
Fundacion Nacional de Dermatologia
Investigators
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Principal Investigator: JAIME SOTO, MD Fundacion Nacional de Dermatologia

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundacion Nacional de Dermatologia
ClinicalTrials.gov Identifier: NCT03096457     History of Changes
Other Study ID Numbers: ABF-BO-2016-102
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion Nacional de Dermatologia:
leishmaniasis
L.braziliensis
paromomycin cream
intralesional pentamidine
leishmaniasis local therapy
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Paromomycin
Pentamidine
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents
Trypanocidal Agents