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

Cutaneous Leishmaniasis, American Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06000514
• Other study ID #: SM29CL.1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 17, 2019
• Est. completion date: July 7, 2022

Study information

• Verified date: August 2023
• Source: Hospital Universitário Professor Edgard Santos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 7, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis, American
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Corte de Pedra Health Post	Presidente Tancredo Neves	Bahia

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitário Professor Edgard Santos	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Oswaldo Cruz Foundation

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure	Complete re epithelization of the ulcer(s), without any area of ulceration and without raised or infiltrated borders.	90 days