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

Hospital Universitário Professor Edgard Santos

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cutaneous Leishmaniasis, American

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06000514

SM29CL.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Topical Sm29 and Sbv

Experimental group

Description:

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

Treatment:

Drug: Sm29 Protein, Schistosoma Mansoni

Drug: Pentavalent antimony (Sbv)

Topical Placebo and Sbv

Placebo Comparator group

Description:

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

Treatment:

Drug: Pentavalent antimony (Sbv)