Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis
NCT ID: NCT02656797
Last Updated: 2022-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2018-01-30
2021-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Liposomal Amphotericin in Disseminated Leishmaniasis
NCT02025491
Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
NCT00628719
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children
NCT01032187
Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil
NCT01310738
Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis
NCT01050777
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Cure rate will be compared between patients treated with Amphotericin-B 0.4% Liposomal Gel and patients treated with placebo gel preparation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AM-B
Topical Amphotericin-B 0.4% liposomal gel
Topical Amphotericin-B 0.4% liposomal gel
Topical Amphotericin-B 0.4% liposomal gel
Placebo
Placebo gel preparation
Topical Amphotericin-B 0.4% liposomal gel
Topical Amphotericin-B 0.4% liposomal gel
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Topical Amphotericin-B 0.4% liposomal gel
Topical Amphotericin-B 0.4% liposomal gel
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 1 to 5 lesions
* Signed informed consent
Exclusion Criteria
* Significant co-morbidity
* Pregnancy or breast-feeding at enrollment
* Previous treatment for leishmaniasis
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Soroka University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AMIR HOREV
Head, Pediatric dermatology Service, Soroka University Medical Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amir Horev, MD
Role: PRINCIPAL_INVESTIGATOR
Soroka University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Soroka University Medical Center
Beersheba, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
sor017715ctil
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.