Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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.

ID
Name
SM29CL.1
Description
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.
Trial arms
Trial start
2019-01-17
Estimated PCD
2022-04-06
Trial end
2022-07-07
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Topical Sm29 and Sbv
Other names:
Pentavalent antimony (Sbv)
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.
Arms:
Topical Placebo and Sbv, Topical Sm29 and Sbv
Other names:
Placebo cream
Size
20
Primary endpoint
Cure
90 days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized and controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Both arms will use the same active standard medication (Sbv) and both arms will use a topical cream (one arm - placebo; the other Sm29).', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-08-21

1 organization

2 products

2 indications

Organization
Hospital Universitário Professor Edgard Santos
Product
Sm29 Protein
Indication
Cutaneous Leishmaniasis
Indication
Native American myxoid fibrosarcoma
Product
Pentavalent antimony (Sbv)