None listed
Conditions
Interventions
Group 1 Type of group
Paromomycin Alone Cream (15% paromomycin topical cream) topical application to CL lesions once daily for 20 days
Group name:Group 2 Type of group
WR 279396 (15% paromomycin + 0.5% gentamicin topical cream) topical application to CL lesions once daily for 20 days
Sponsors
Oficina del Cirujano General, Departamento del Ejercito de Estados Unidos,
Eligibility
Sex/Gender
All
Age
5 Years to 65 Years
Inclusion criteria
Inclusion criteria: • The patient is male or female older than or equal to 5 years of age • The patient or legal guardian is in a position to give informed consent or written consent, as appropriate • The patient has a diagnosis of LC in at least one lesion detected by one of the following methods: I) positive culture of promastigotes or 2) microscopic identification of amastigotes in the smear of the lesion • The patient has at least one ulcer lesion> I cm and <5 cm, which meets the criteria of an index lesion • The patient is willing to undergo other forms of treatment for LC, including other investigative treatments during the study • In the opinion of the investigator, the patient (or his legal guardian) is able to understand and comply with the protocol • If she is a woman of reproductive age, the patient presented a negative serum pregnancy test during the selection and agreed to use an acceptable method of birth control during the treatment phase and for one month after the end of the treatment. • The patient has adequate venous access for blood draws
Exclusion criteria
Exclusion criteria: • The patient has only one lesion whose characteristics include any of the following: warty or nodular lesion (non-ulcer) lesion 10 lesions • The patient is a woman who is breastfeeding • The patient has an active neoplasm or has a history of removal of a solid, metastatic or hematologic tumor with the exception of basal cell carcinoma or squamous cell skin • The patient has a significant organic abnormality, a chronic disease such as diabetes, severe hearing loss, evidence of liver or kidney dysfunction, or levels of creatinine, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) beyond 15% above of the Upper Normal Limit (LSN) according to the definition of the normal ranges of the clinical laboratory • The patient was treated for leishmaniasis with a medication with pentavalent antimony, such as sodium stibogluconate (Pemostam): meglumine antimony agent (Glucantime); amphotericin B (includes amphotericin B Uposomal and amphotericin B deoxycholate); WR 279396: or other medications containing paromomycin (administered parenterally or topically) or methylbenzethonium chloride (MBCL); gentamicin: fluconazole; ketoconazole; pentarrudina; miltefosinc: azithromycin or allopurinol within 8 weeks prior to beginning study treatments • The patient has a history of confirmed diagnosis or suspected hypersensitivity or idiosyncratic reactions to the amynoglycosides • The patient has another topical disease / condition that could interfere with the objectives of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Final clinical cure was defined as follows: - Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR, - Subject has initial clinical improvement (> 50% re-epithelialization of index lesion by nominal Day 63 followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND, - Subject has no relapse of index lesion by Day 168. Relapse was defined as an index lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or an index lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168. Measure:Final Clinical Cure for Index Lesions Timepoints:Initial clinical cure by day 63 and no relapse by day 168 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults Measure:Detectable Paromomycin Plasma Levels Timepoints:Day 4, 7, 12, 17, 20, 28 ; Outcome name:Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279396 in children Measure:Paromomycin Plasma Concentrations in Children Timepoints:0 and 4 hours on days 1 and 20 ; Outcome name:Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults Measure:Pharmacokinetic Parameter: Cmax Timepoints:0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 ; Outcome name:Pharmacokinetic Parameter: Tmax Measure:Pharmacokinetic Parameter: Tmax Timepoints:0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 ; Outcome name:Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults Measure:Pharmacokinetic Parameter: Area Under the Curve (AUC) Timepoints:0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 ; Outcome name:t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults Measure:Pharmacokinetic Parameter: t(1/2) Timepoints:0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 ; Outcome name:Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults Measure:Pharmacokinetic Parameter: Cmax/D Timepoints:0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 ; Outcome name:Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults Measure:Pharmacokinetic Parameter: AUC/D Timepoints:Days 1 and 20 ; | — |
Countries
Peru
Contacts
Public ContactAlejandro Llanos
INSTITUTO DE MEDICINA TROPICAL ALEXANDER VON HUMBOLDT - UPCH
Outcome results
None listed