Cutaneous Leishmaniasis, AmericanPhase 1/2NCT06000514
Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.
A Phase 1/2 study testing Sm29 Protein, Schistosoma Mansoni and Pentavalent antimony (Sbv) in people with Cutaneous Leishmaniasis, American, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cutaneous Leishmaniasis, American
- What is being tested?
- Sm29 Protein, Schistosoma Mansoni and Pentavalent antimony (Sbv)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Jan 2019to 7 Jul 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of cutaneous leishmaniasis (typical ulcerated lesion); 1 to 2 ulcers; ulcer size ranging from 10-40mm; disease duration between 20-90 days.
Who cannot join
- Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of immunosupressive drugs; pregnancy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Corte de Pedra Health Post
Presidente Tancredo Neves, Estado de Bahia, 40000
About this study
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.
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.
Read the 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.
- Conditions
- Cutaneous Leishmaniasis, American
- Being tested
- Sm29 Protein, Schistosoma Mansoni, Pentavalent antimony (Sbv)
- Keywords
- Cutaneous Leishmaniasis, Sm29, L. braziliensis
- Medical subject headings
- Leishmaniasis, Mucocutaneous, Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sm29 Protein, Schistosoma MansoniDrug
Also called Pentavalent antimony (Sbv)
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)Drug
Also called Placebo cream
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.
| Study group | Role | What they receive |
|---|---|---|
| Topical Sm29 and Sbv | Experimental | Use of topical Sm29 twice a day during 20 days and systemic Sbv during 20 days Receives: Drug: Sm29 Protein, Schistosoma Mansoni; Drug: Pentavalent antimony (Sbv) |
| Topical Placebo and Sbv | Placebo comparator | Use of topical placebo twice a day during 20 days and systemic Sbv during 20 days Receives: Drug: Pentavalent antimony (Sbv) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure
Complete re epithelization of the ulcer(s), without any area of ulceration and without raised or infiltrated borders.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start17 Jan 2019
- Primary completion6 Apr 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Leishmaniasis, AmericanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized and controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitário Professor Edgard Santos
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Oswaldo Cruz Foundation
- Responsible party
- Principal investigator, Paulo Roberto Lima Machado, Hospital Universitário Professor Edgard Santos
- Investigators
- SERGIO C OLIVEIRA, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000514
- Sponsor's protocol ID
- SM29CL.1
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not to be shared.
Publications
Lago T, Peixoto F, Mambelli F, Carvalho LP, Guimaraes LH, Carvalho AM, Cardoso L, Machado PRL, Scott P, Lago J, Andrade JM, Fahel JS, Oliveira SC, Carvalho EM. Use of topical rSm29 in combination with intravenous meglumine antimoniate in the treatment of cutaneous leishmaniasis: A randomized controlled trial. Int J Infect Dis. 2024 Oct;147:107206. doi: 10.1016/j.ijid.2024.107206. Epub 2024 Aug 13.
PubMed 39147194
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06000514
- Acronym / sponsor ID
- SM29CL.1
- Conditions
- Cutaneous Leishmaniasis, American
- Keywords
- Cutaneous Leishmaniasis, Sm29, L. braziliensis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Universitário Professor Edgard SantosUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Oswaldo Cruz Foundation
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized and controlled
| Arm | Type | Receives |
|---|---|---|
| Topical Sm29 and Sbv | Experimental | Drug: Sm29 Protein, Schistosoma Mansoni, Drug: Pentavalent antimony (Sbv)Use of topical Sm29 twice a day during 20 days and systemic Sbv during 20 days |
| Topical Placebo and Sbv | Placebo comparator | Drug: Pentavalent antimony (Sbv)Use of topical placebo twice a day during 20 days and systemic Sbv during 20 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of cutaneous leishmaniasis (typical ulcerated lesion); 1 to 2 ulcers; ulcer size ranging from 10-40mm; disease duration between 20-90 days.
Key exclusion criteria (1 listed)
- Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of immunosupressive drugs; pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sm29 Protein, Schistosoma MansoniAlso: Pentavalent antimony (Sbv)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. | Drug | Topical Sm29 and Sbv |
| Pentavalent antimony (Sbv)Also: Placebo creamPlacebo cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days. | Drug | Topical Placebo and Sbv, Topical Sm29 and Sbv |
Primary outcome
Cure
Time frame: 90 days
Complete re epithelization of the ulcer(s), without any area of ulceration and without raised or infiltrated borders.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Derived from this study: PubMed 39147194Lago T, Peixoto F, Mambelli F, Carvalho LP, Guimaraes LH, Carvalho AM, Cardoso L, Machado PRL, Scott P, Lago J, Andrade JM, Fahel JS, Oliveira SC, Carvalho EM. Use of topical rSm29 in combination with intravenous meglumine antimoniate in the treatment of cutaneous leishmaniasis: A randomized controlled trial. Int J Infect Dis. 2024 Oct;147:107206. doi: 10.1016/j.ijid.2024.107206. Epub 2024 Aug 13.
- Individual participant dataSharing planned: No. Not to be shared.
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Cutaneous Leishmaniasis, Cutaneous Leishmaniasis, American
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SERGIO C OLIVEIRA, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sm29 Protein, Schistosoma Mansoni and Pentavalent antimony (Sbv) in people with Cutaneous Leishmaniasis, American, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.