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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2022-07-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cutaneous Leishmaniasis, American

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized and controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Both arms will use the same active standard medication (Sbv) and both arms will use a topical cream (one arm - placebo; the other Sm29).

Study Groups

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Topical Sm29 and Sbv

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

Group Type EXPERIMENTAL

Sm29 Protein, Schistosoma Mansoni

Intervention Type 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.

Pentavalent antimony (Sbv)

Intervention Type 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.

Topical Placebo and Sbv

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

Group Type PLACEBO_COMPARATOR

Pentavalent antimony (Sbv)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Pentavalent antimony (Sbv) Placebo cream

Eligibility Criteria

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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.