Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06040489

Enrollment

100

Registered

2023-09-15

Start date

2022-06-22

Completion date

2026-06-30

Last updated

2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leishmaniasis; Brazilian, Leishmaniasis, Mucocutaneous

Keywords

Elderly, Miltefosine, Leishmaniasis, Pentoxifylline, Liposomal amphotericin b, Treatment

Brief summary

Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis

Interventions

DRUGMiltefosine 50mg

Oral Miltefosine 50mg bid

DRUGPentoxifylline 400mg

Oral Pentoxifylline 400mg tid

DRUGLiposomal Amphotericin B

Intravenous 25 to 40mg/kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis * Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase * Agree and sing informed consent form

Exclusion criteria

* Previous treatment with leishmanicidal drugs in the last 6 months * Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms) * Serum creatinine or urea 1.5 times the upper limit of normal * Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus * history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline * Pregnant and breastfeeding women * Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency

Design outcomes

Primary

Measure	Time frame	Description
Cure	90 days after the begin of treatment	Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)

Secondary

Measure	Time frame	Description
Adverse effects	30 days after drug interruption	Presence laboratorial or clinica changes during treatment that lead to treatment interruption

Countries

Brazil

Contacts

Primary ContactRaimunda Sampaio, PhD

rnrsampaio@hotmail.com+556120285415

Backup ContactSofia Martins, PhD

sofiasalesm@gmail.com+556120285415

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026