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Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.

Sponsor
Hospital Universitário Professor Edgard Santos (Other)
Overall Status
Completed
CT.gov ID
NCT06000514
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Oswaldo Cruz Foundation (Other)
20
Enrollment
1
Location
2
Arms
41.6
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project is composed of a phase I study with the purpose of evaluating adverse reactions and the best dose to be used of Sm29 and a phase II randomized controlled study with 3 arms with the purpose of comparing the efficacy of meglumine antimoniate associated with Sm29, with meglumine antimoniate plus placebo and meglumine antimoniate alone in the treatment of cutaneous leishmaniasis.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sm29 Protein, Schistosoma Mansoni
  • Drug: Pentavalent antimony (Sbv)
 Phase 1/Phase 2

Detailed Description

The phase I study was performed in 10 healthy subjects and 10 patients with CL. In healthy individuals (N=5) Sm29 was applied to healthy skin at a concentration of 5ug and in another 5 Sm29 was used at a dose of 10ug applied twice a day for 20 days. A phase I study was also carried out in 10 patients with CL to assess the occurrence of adverse reactions to Sm29 applied to the ulcerated lesion and to compare the use of two doses of Sm29. In 5 patients, Sm29 was used at a dose of 5ug and applied twice a day, and in 10 patients, a dose of 10ug of Sm29 was used, also applied twice a day. The 10 patients were also treated with glucantime at a dose of 20mg/kg/weight with a maximum dose of 1200mg/day intravenously for 20 days. Patients were evaluated on days 10, 20 and 30 for adverse reactions.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized and controlledRandomized and controlled
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Both arms will use the same active standard medication (Sbv) and both arms will use a topical cream (one arm - placebo; the other Sm29).
Primary Purpose:
Treatment
Official Title:
Association of Topical Sm29 in Gold Nanoparticles With Intravenous Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania Braziliensis: A Randomized Controlled Trial.
Actual Study Start Date :
Jan 17, 2019
Actual Primary Completion Date :
Apr 6, 2022
Actual Study Completion Date :
Jul 7, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Topical Sm29 and Sbv

Use of topical Sm29 twice a day during 20 days and systemic Sbv during 20 days

Drug: Sm29 Protein, Schistosoma Mansoni
Sm29 cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.
Other Names:
  • Pentavalent antimony (Sbv)

    • Drug: Pentavalent antimony (Sbv)
    Placebo cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.
    Other Names:
  • Placebo cream

    		•
    Placebo Comparator: Topical Placebo and Sbv

    Use of topical placebo twice a day during 20 days and systemic Sbv during 20 days

    Drug: Pentavalent antimony (Sbv)
    Placebo cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.
    Other Names:
  • Placebo cream

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cure [90 days]

      Complete re epithelization of the ulcer(s), without any area of ulceration and without raised or infiltrated borders.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical diagnosis of cutaneous leishmaniasis (typical ulcerated lesion); 1 to 2 ulcers; ulcer size ranging from 10-40mm; disease duration between 20-90 days.
    Exclusion Criteria:
    • Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of immunosupressive drugs; pregnancy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Corte de Pedra Health Post Presidente Tancredo Neves Bahia Brazil 40000

    Sponsors and Collaborators

    • Hospital Universitário Professor Edgard Santos
    • Conselho Nacional de Desenvolvimento Científico e Tecnológico
    • Oswaldo Cruz Foundation

    Investigators

    • Principal Investigator: SERGIO C OLIVEIRA, PhD, Federal University of Minas Gerais

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paulo Roberto Lima Machado, Head of Immunology Service, Hospital Universitário Professor Edgard Santos
    ClinicalTrials.gov Identifier:
    NCT06000514
    Other Study ID Numbers:
    • SM29CL.1
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Paulo Roberto Lima Machado, Head of Immunology Service, Hospital Universitário Professor Edgard Santos
    Cutaneous Leishmaniasis
    Sm29
    L. braziliensis
    Additional relevant MeSH terms:
    Leishmaniasis
    Leishmaniasis, Cutaneous

    Study Results

    No Results Posted as of Aug 21, 2023