Efficacy of topical nano-liposomal Amphotericin B in the treatment of cutaneous leishmaniasis caused by L. major

Double blind, randomized phase 3 efficacy trial of topical nano-liposomal Amphotericin B in the treatment of cutaneous leishmaniasis caused by L. major

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201510161475N10

Enrollment

110

Registered

2016-02-29

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: topical Nano Liposomal form of Amphotericin B twice a day for 28 days. Intervention 2: Placebo ointment without liposomes or Amphotericin B.

Treatment - Drugs

topical Nano Liposomal form of Amphotericin B twice a day for 28 days

Placebo ointment without liposomes or Amphotericin B

Eligibility

Sex/Gender

All

Age

12 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Males & females 12-60 years of age; parasitologically proven CL caused by L. major (identification is done by using PCR); Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test if requested by the physician; Ability to understand the principles of the trial; Signed informed consent voluntarily and knowingly.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Complete reepithelization of the lesions. Timepoint: Monthly. Method of measurement: Digital photos.	—

Secondary

Measure	Time frame
Decrease size of the lesions. Timepoint: Monthly. Method of measurement: Digital photos.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Meshkforoush

Payegah 8th Shekari

khamesipour_ali@yahoo.com+98 31 3577 5037

Outcome results

None listed

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