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Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

Primary Purpose

Leishmaniasis, Cutaneous, Leishmania Braziliensis Complex, Leishmaniasis, American

Status
Completed
Phase
Phase 2
Locations
Bolivia
Study Type
Interventional
Intervention
Paromomycin Sulfate
Pentamidine Isethionate
Placebo
Sponsored by
Fundacion Nacional de Dermatologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leishmaniasis, Cutaneous focused on measuring leishmaniasis, L.braziliensis, paromomycin cream, intralesional pentamidine, leishmaniasis local therapy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Local Palos Blancos
  • Hospital Dermatologico de Jorochito

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Group 1 - Paromomycin cream

Group 2. Local Injectable Pentamidine

Group 3. Vehicle control

Arm Description

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.

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.

10% Urea en parafilm cream will be used in similar ways as paromomycin cream in group 1

Outcomes

Primary Outcome Measures

Change of Lesion size
change of lesion area at 6 months after treatment compared to baseline

Secondary Outcome Measures

Number of participants with treated-related adverse events
Adverse events will measured according to CTCAE 4.03

Full Information

First Posted
March 9, 2017
Last Updated
February 1, 2021
Sponsor
Fundacion Nacional de Dermatologia
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1. Study Identification

Unique Protocol Identification Number
NCT03096457
Brief Title
Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia
Official Title
Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
March 18, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Nacional de Dermatologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis, Cutaneous, Leishmania Braziliensis Complex, Leishmaniasis, American, Leishmaniasis; American, Cutaneous
Keywords
leishmaniasis, L.braziliensis, paromomycin cream, intralesional pentamidine, leishmaniasis local therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Paromomycin cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2. Local Injectable Pentamidine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 3. Vehicle control
Arm Type
Placebo Comparator
Arm Description
10% Urea en parafilm cream will be used in similar ways as paromomycin cream in group 1
Intervention Type
Drug
Intervention Name(s)
Paromomycin Sulfate
Intervention Description
topical application 2 times a day during 20 days
Intervention Type
Drug
Intervention Name(s)
Pentamidine Isethionate
Intervention Description
3 Intralesional injections at days 1,3 and 5
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
topical application 2 times a day during 20 days
Primary Outcome Measure Information:
Title
Change of Lesion size
Description
change of lesion area at 6 months after treatment compared to baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants with treated-related adverse events
Description
Adverse events will measured according to CTCAE 4.03
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JAIME SOTO, MD
Organizational Affiliation
Fundacion Nacional de Dermatologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Local Palos Blancos
City
Palos Blancos
State/Province
La Paz
ZIP/Postal Code
00000
Country
Bolivia
Facility Name
Hospital Dermatologico de Jorochito
City
Jorochito
State/Province
SC
Country
Bolivia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9248897
Citation
Oliveira-Neto MP, Schubach A, Mattos M, da Costa SC, Pirmez C. Intralesional therapy of American cutaneous leishmaniasis with pentavalent antimony in Rio de Janeiro, Brazil--an area of Leishmania (V.) braziliensis transmission. Int J Dermatol. 1997 Jun;36(6):463-8. doi: 10.1046/j.1365-4362.1997.00188.x.
Results Reference
background
PubMed Identifier
22855754
Citation
Vasconcellos Ede C, Pimentel MI, Schubach Ade O, de Oliveira Rde V, Azeredo-Coutinho RB, Silva Fda C, Salgueiro Mde M, Moreira JS, Madeira Mde F, Baptista C, Valete-Rosalino CM. Intralesional meglumine antimoniate for treatment of cutaneous leishmaniasis patients with contraindication to systemic therapy from Rio de Janeiro (2000 to 2006). Am J Trop Med Hyg. 2012 Aug;87(2):257-60. doi: 10.4269/ajtmh.2012.11-0612.
Results Reference
background
PubMed Identifier
23390069
Citation
Soto J, Rojas E, Guzman M, Verduguez A, Nena W, Maldonado M, Cruz M, Gracia L, Villarroel D, Alavi I, Toledo J, Berman J. Intralesional antimony for single lesions of bolivian cutaneous leishmaniasis. Clin Infect Dis. 2013 May;56(9):1255-60. doi: 10.1093/cid/cit049. Epub 2013 Feb 6.
Results Reference
background
PubMed Identifier
26903605
Citation
Soto J, Paz D, Rivero D, Soto P, Quispe J, Toledo J, Berman J. Intralesional Pentamidine: A Novel Therapy for Single Lesions of Bolivian Cutaneous Leishmaniasis. Am J Trop Med Hyg. 2016 Apr;94(4):852-6. doi: 10.4269/ajtmh.15-0640. Epub 2016 Feb 22.
Results Reference
background
PubMed Identifier
23388004
Citation
Ben Salah A, Ben Messaoud N, Guedri E, Zaatour A, Ben Alaya N, Bettaieb J, Gharbi A, Belhadj Hamida N, Boukthir A, Chlif S, Abdelhamid K, El Ahmadi Z, Louzir H, Mokni M, Morizot G, Buffet P, Smith PL, Kopydlowski KM, Kreishman-Deitrick M, Smith KS, Nielsen CJ, Ullman DR, Norwood JA, Thorne GD, McCarthy WF, Adams RC, Rice RM, Tang D, Berman J, Ransom J, Magill AJ, Grogl M. Topical paromomycin with or without gentamicin for cutaneous leishmaniasis. N Engl J Med. 2013 Feb 7;368(6):524-32. doi: 10.1056/NEJMoa1202657.
Results Reference
background
PubMed Identifier
30260376
Citation
Soto J, Soto P, Ajata A, Luque C, Tintaya C, Paz D, Rivero D, Berman J. Topical 15% Paromomycin-Aquaphilic for Bolivian Leishmania braziliensis Cutaneous Leishmaniasis: A Randomized, Placebo-controlled Trial. Clin Infect Dis. 2019 Feb 15;68(5):844-849. doi: 10.1093/cid/ciy619.
Results Reference
derived

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Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

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