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

NCT06000514 | Completed Phase 1 DMC

• 1 other identifier: SM29CL.1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Leishmaniasis, American

Keywords

Cutaneous Leishmaniasis; Sm29; L. braziliensis

Outcome Measures

Primary Outcomes (1)

• Cure

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

  90 days

Study Arms (2)

Topical Sm29 and Sbv

EXPERIMENTAL

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

Drug: Sm29 Protein, Schistosoma Mansoni; Drug: Pentavalent antimony (Sbv)

Topical Placebo and Sbv

PLACEBO COMPARATOR

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

Drug: Pentavalent antimony (Sbv)

Interventions

Sm29 Protein, Schistosoma Mansoni DRUG

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.

Also known as: Pentavalent antimony (Sbv)

Topical Sm29 and Sbv

Pentavalent antimony (Sbv) DRUG

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.

Also known as: Placebo cream

Topical Placebo and Sbv; Topical Sm29 and Sbv

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Clinical diagnosis of cutaneous leishmaniasis (typical ulcerated lesion); 1 to 2 ulcers; ulcer size ranging from 10-40mm; disease duration between 20-90 days.

You may not qualify if:

• Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of immunosupressive drugs; pregnancy.

Sponsors & Collaborators

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

Study Sites (1)

Corte de Pedra Health Post

Presidente Tancredo Neves, Estado de Bahia, 40000, Brazil

Location

Related Publications (1)

• Lago T, Peixoto F, Mambelli F, Carvalho LP, Guimaraes LH, Carvalho AM, Cardoso L, Machado PRL, Scott P, Lago J, Andrade JM, Fahel JS, Oliveira SC, Carvalho EM. Use of topical rSm29 in combination with intravenous meglumine antimoniate in the treatment of cutaneous leishmaniasis: A randomized controlled trial. Int J Infect Dis. 2024 Oct;147:107206. doi: 10.1016/j.ijid.2024.107206. Epub 2024 Aug 13.

  PMID: 39147194 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Mucocutaneous; Leishmaniasis, Cutaneous

Interventions

Sm29 protein, Schistosoma mansoni

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• SERGIO C OLIVEIRA, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both arms will use the same active standard medication (Sbv) and both arms will use a topical cream (one arm - placebo; the other Sm29).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Immunology Service

Model Details: Randomized and controlled

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 21, 2023
• Study Start: January 17, 2019
• Primary Completion: April 6, 2022
• Study Completion: July 7, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)