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Clinical trial of efficacy of combination of topical liposomal Amphotericin B and meglumine antimoniate (Glucantime) the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica (Phase 3)

Randomized, double blind, clinical trial on efficacy of topical nano-liposomal amphotericin B for the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica (Phase 3)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201504211475N7
Enrollment
120
Registered
2015-11-22
Start date
2015-10-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Cutaneous leishmaniasis. Cutaneous leishmaniasis

Interventions

Intervention 1: Nano Liposome Amphotricin B. Intervention 2: Treatment with topical nano liposomal form of Amphotericin B twice a day for 28 days.
Treatment - Drugs
Nano Liposome Amphotricin B
Treatment with topical nano liposomal form of Amphotericin B twice a day for 28 days

Sponsors

MoH, EMRO/WHO
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Inclusion criteria: Male or female aged between 12 to 60 years. Parasitologically proven CL due to L. tropica. In general good health based on history and physical examination. Number of lesion at most 5. Lesion size less than 3 cm. Signed informed consent voluntarily and knowingly**. ** Guardian’s signature for volunteer less than 18 years old. Exclusion criteria: Pregnancy lactating women Use of other types of treatment for CL. Involvement in any other drug or vaccine trial during the study period. Known heart, kidney, liver diseases based on history and physical exam.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Complete cure. Timepoint: at week 4, 8, and days 90 and 180. Method of measurement: measurement of lesion status.

Secondary

MeasureTime frame
Lesion(s) partial cure. Timepoint: at week 4, 8 and days 90 and 180. Method of measurement: measurement of lesion size.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohammad Hossein Ghoorchi

Mashhad University of Medical Sciences

ali.khamesipour@gmail.com00

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026