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Leishmaniasis, CutaneousPhase 2/3NCT03096457

Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

A Phase 2/3 study testing Paromomycin Sulfate and Pentamidine Isethionate in people with Leishmaniasis, Cutaneous and Leishmania Braziliensis Complex, run by Fundacion Nacional de Dermatologia at 2 sites in Bolivia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 12 years and older
What is being tested?
Paromomycin Sulfate and Pentamidine Isethionate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesBolivia
Study dates
15 Apr 2017to 1 Apr 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Bolivia2 sites

  • Hospital Dermatologico de Jorochito

    Jorochito, SC

  • Hospital Local Palos Blancos

    Palos Blancos, La Paz Department, 00000

Other trials in Bolivia

About this study

Official title: 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.

Read the 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.

Being tested
Paromomycin Sulfate, Pentamidine Isethionate, Placebo
Keywords
leishmaniasis, L.braziliensis, paromomycin cream, intralesional pentamidine, leishmaniasis local therapy
Medical subject headings
Leishmaniasis, Cutaneous, Leishmaniasis, Mucocutaneous, Leishmaniasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paromomycin SulfateDrug

    topical application 2 times a day during 20 days

  • Pentamidine IsethionateDrug

    3 Intralesional injections at days 1,3 and 5

  • PlaceboOther

    topical application 2 times a day during 20 days

Study groups in NCT03096457
Study groupRoleWhat they receive
Group 1 - Paromomycin creamExperimental40 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.
Receives: Drug: Paromomycin Sulfate
Group 2. Local Injectable PentamidineActive comparator20 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.
Receives: Drug: Pentamidine Isethionate
Group 3. Vehicle controlPlacebo comparator10% Urea en parafilm cream will be used in similar ways as paromomycin cream in group 1
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Lesion size

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

    Measured: 6 months

Secondary outcomes (1)

  1. Number of participants with treated-related adverse events

    Adverse events will measured according to CTCAE 4.03

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2017
  2. Study start15 Apr 2017
  3. Primary completion18 Mar 2018
  4. Study completion1 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03096457
Sponsor's protocol ID
ABF-BO-2016-102
Status last verified
Jul 2018
First submitted
9 Mar 2017
Last updated
2 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9248897

  • 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.

    PubMed 22855754

  • 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.

    PubMed 23390069

  • 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.

    PubMed 26903605

  • 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.

    PubMed 23388004

  • 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.

    PubMed 30260376

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Paromomycin Sulfate and Pentamidine Isethionate in people with Leishmaniasis, Cutaneous and Leishmania Braziliensis Complex, run by Fundacion Nacional de Dermatologia at 2 sites in Bolivia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Bolivia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Lesion size (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03096457, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.

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