Evidence map›Paper›PMID 31048871›Full record

Trial reportPLoS neglected tropical diseases2019

Topical paromomycin for New World cutaneous leishmaniasis.

Néstor Sosa, Juan Miguel Pascale, Ana I Jiménez, Jeanne A Norwood, Mara Kreishman-Detrick, Peter J Weina, Kendra Lawrence, William F McCarthy, Ryan C Adams, Charles Scott and 3 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
10.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 74 citations in OpenAlex.

  1. Pooled it
  2. Interventions for American cutaneous and mucocutaneous leishmaniasis.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Review
  8. Molecular Mechanisms of Drug Resistance inPathogens (Basel, Switzerland) · 2024
    Review
  9. The first evaluation of the in vitro effects of silver(I)-N-heterocyclic carbene complexes on Encephalitozoon intestinalis and Leishmania major promastigotes.Journal of biological inorganic chemistry : JBIC : a publication of the Society of Biological Inorganic Chemistry · 2024
    Article
  10. Article
  11. Rapid detection, quantification and speciation ofbioRxiv : the preprint server for biology · 2024
    Article
  12. Article
  13. Article
  14. Amine-Linked Flavonoids as Agents Against Cutaneous Leishmaniasis.Antimicrobial agents and chemotherapy · 2023
    Article
  15. Article
  16. In vitro Anti-Leishmanial Activities of Methanol Extract ofJournal of experimental pharmacology · 2023
    Article
  17. Review
  18. Article
  19. Article
  20. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 3 countries.

Néstor SosaInstituto Conmemorativo Gorgas de Estudios de la Salud, Avenida Justo Arosemena, Panama City, Panama.ORCID 0000-0002-5244-5437
Juan Miguel PascaleInstituto Conmemorativo Gorgas de Estudios de la Salud, Avenida Justo Arosemena, Panama City, Panama.ORCID 0000-0003-3258-1359
Ana I JiménezInstituto Conmemorativo Gorgas de Estudios de la Salud, Avenida Justo Arosemena, Panama City, Panama.
Jeanne A NorwoodUS Army Medical Materiel Development Activity (USAMMDA), Fort Detrick, MD, United States of America.
Mara Kreishman-DetrickWalter Reed Army Institute of Research, Silver Spring, MD, United States of America.
Peter J WeinaWalter Reed National Military Medical Center, Bethesda, MD, United States of America.
Kendra LawrenceUS Army Medical Materiel Development Activity (USAMMDA), Fort Detrick, MD, United States of America.
William F McCarthyUS Army Medical Materiel Development Activity (USAMMDA), Fort Detrick, MD, United States of America.
Ryan C AdamsUS Army Medical Materiel Development Activity (USAMMDA), Fort Detrick, MD, United States of America.
Charles ScottFast-Track Drugs and Biologics, North Potomac MD, United States of America.
Janet RansomFast-Track Drugs and Biologics, North Potomac MD, United States of America.
Douglas TangFast-Track Drugs and Biologics, North Potomac MD, United States of America.
Max GroglUS Naval Medical Research Unit No. 6, in Lima, Peru.
United States Army Medical Research and Development Command · USFast Track Drugs and Biologics · USInstituto Conmemorativo Gorgas de Estudios de la Salud · PAUnited States Naval Medical Research Unit SOUTH · PEWalter Reed Army Institute of Research · USWalter Reed National Military Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundParomomycin-based topical treatments were shown to be effective in curing cutaneous leishmaniasis (CL) lesions caused by Leishmania major in Tunisia. Cure rates of an index lesion were approximately 80%. As a follow on, we conducted a similar Phase 3 trial in Panama to demonstrate the efficacy of these treatments against New World species. The primary objective was to determine if a combination topical cream (paromomycin-gentamicin) resulted in statistically superior final clinical cure rates of an index lesion compared to a paromomycin alone topical cream for the treatment of CL, primarily caused by Leishmania panamensis.

methodsWe conducted a randomized, double blind, Phase 3 trial of topical creams for the treatment of CL caused by Leishmania spp. Three hundred ninety nine patients with one to ten CL lesions were treated by topical application once daily for 20 days. The primary efficacy endpoint was percentage of subjects with clinical cure of an index lesion confirmed to contain Leishmania with no relapse.

resultsThe clinical cure of the index lesion for paromomycin-gentamicin was 79% (95% CI; 72 to 84) and for paromomycin alone was 78% (95% CI; 74 to 87) (p = 0.84). The most common adverse events considered related to study cream application were mild to moderate dermatitis, pain, and pruritus.

conclusionsSuperiority of paromomycin-gentamicin was not demonstrated. However, the approximately 80% cure rates for both topical creams were similar to those demonstrated in Tunisia and previously reported with parenteral antimonials.

Indexed as

Administration, TopicalAdolescentAdultAgedAntiprotozoal AgentsChildChild, PreschoolDrug Therapy, CombinationFemaleGentamicinsHumansLeishmania majorLeishmaniasis, CutaneousMaleMiddle AgedParomomycinAntiprotozoal AgentsGentamicinsParomomycin

Identifiers

PMID31048871
PMCPMC6497224
OpenAlexW2943731743

What OpenQuestion holds

Textmetadata
LicenceCC0
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.