A Phase 1/2 interventional study of Liposomal amphotericin B (AmBisome®) in Cutaneous Leishmaniasis, American, sponsored by Hospital Universitário Professor Edgard Santos. Completed at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by Hospital Universitário Professor Edgard Santos · Phase 1/2, Interventional, and Treatment
A randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin B associated with the highest cure rate in Cutaneous Leishmaniasis (CL). We selected 28 patients of both sexes, aged 60 years or older, diagnosed with CL and confirmed by detection of L. braziliensis DNA. The groups were treated with different total doses of medication: G1: 12 mg/kg; G2: 18mg/kg; G3: 24 mg/kg. Clinical and laboratory evaluations were carried out during the period of 180 days (D0, D15, D30, D60, D120, D150 and D180).
The study was carried out through a randomized and double-blind pilot clinical trial, with the inclusion of patients treated at the Corte de Pedra Health Center, endemic region for Cutaneous Leishmaniasis. Twenty-eight patients participated in the study, after accepting and signing the Free and Informed Consent Form they were randomized through the list generated electronically by the website www.randomization.com and allocated into three groups.
The groups were treated with liposomal amphotericin B (AmBisome®) with three different total doses: Group 1 (G1) total dose of 12 mg/kg (10 patients). Group 2 (G2): 18 mg/kg (9 patients). Group 3 (G3): 24 mg/kg (9 patients). The drug was used twice a week in a hospital outpatient setting. Clinical evaluations were performed before starting therapy (D0), and at D15, D30, D60, D120 and D180. Laboratory evaluations (hemogram, BUN, Creatinine, K, ALT, AST) were determined on D0, D15 and D30 or D60.
21 studies on the registry are indexed under Leishmaniasis, Mucocutaneous; 7 are open to participants now.
This study's enrollment of 28 is below the median of 49 across 16 interventional studies indexed under Leishmaniasis, Mucocutaneous.
Browse Leishmaniasis, Mucocutaneous studies →Hospital Universitário Professor Edgard Santos is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 12 mg/kg
Drug: Liposomal amphotericin B (AmBisome®)
Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 18 mg/kg
Drug: Liposomal amphotericin B (AmBisome®)
Liposomal amphotericin B (AmBisome®) - 3mg/kg twice a week; total dose of 24 mg/kg
Drug: Liposomal amphotericin B (AmBisome®)
Liposomal amphotericin B (AmBisome®) - intravenous use, twice a week until total dose is achieved
Total initial cicatrization
Healing of the total ulcer area, without elevation of the ulcer edges upon clinical evaluation
Time frame: 30 to 90 days after the first day of treatment
Total final cicatrization
Healing of the total ulcer area, without elevation of the ulcer edges upon clinical evaluation
Time frame: 30 to 180 days after the first day of treatment
Time to cure
Number of days from the first day of treatment until total ulcer cicatrization
Time frame: 30 to 180 days after the first day of treatment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Liposomal amphotericin B
Leishmaniasis, Mucocutaneous →
Hospital Universitário Professor Edgard Santos