- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06000514
Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.
August 17, 2023 updated by: Paulo Roberto Lima Machado, Hospital Universitário Professor Edgard Santos
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bahia
-
Presidente Tancredo Neves, Bahia, Brazil, 40000
- Corte de Pedra Health Post
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Topical Sm29 and Sbv
Use of topical Sm29 twice a day during 20 days and systemic Sbv during 20 days
|
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.
Other Names:
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.
Other Names:
|
Placebo Comparator: Topical Placebo and Sbv
Use of topical placebo twice a day during 20 days and systemic Sbv during 20 days
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cure
Time Frame: 90 days
|
Complete re epithelization of the ulcer(s), without any area of ulceration and without raised or infiltrated borders.
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: SERGIO C OLIVEIRA, PhD, Federal University of Minas Gerais
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2019
Primary Completion (Actual)
April 6, 2022
Study Completion (Actual)
July 7, 2022
Study Registration Dates
First Submitted
July 19, 2023
First Submitted That Met QC Criteria
August 17, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 17, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SM29CL.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not to be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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