Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

February 1, 2021 updated by: Fundacion Nacional de Dermatologia

Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • La Paz
      • Palos Blancos, La Paz, Bolivia, 00000
        • Hospital Local Palos Blancos
    • SC
      • Jorochito, SC, Bolivia
        • Hospital Dermatologico de Jorochito

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.
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.

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
topical application 2 times a day during 20 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Lesion size
Time Frame: 6 months
change of lesion area at 6 months after treatment compared to baseline
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treated-related adverse events
Time Frame: 1 month
Adverse events will measured according to CTCAE 4.03
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2017

Primary Completion (ACTUAL)

March 18, 2018

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 24, 2017

First Posted (ACTUAL)

March 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leishmaniasis, Cutaneous

Clinical Trials on Paromomycin Sulfate

3
Subscribe