safety and efficacy comparison trial of topical nano-liposomal form of Amphotericin B with national standard treatment for cutaneous leishmaniasis caused by Leishmania major (Phase 3)

Open safety and efficacy trial of topical nano-liposomal form of Amphotericin B in comparison with national standard treatment for the treatment of cutaneous leishmaniasis caused by Leishmania major (Phase 3)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201612101475N11

Enrollment

150

Registered

2017-02-17

Start date

2016-12-15

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 Amphotericin B 0.4% (SinaAmpholeish) twice a day for 28 days. Intervention 2: Standard treatment of weekly injections of megumine antimonite (Glucantime) plus or

Treatment - Drugs

Topical nano-liposomal Amphotericin B 0.4% (SinaAmpholeish) twice a day for 28 days

Standard treatment of weekly injections of megumine antimonite (Glucantime) plus or without biweekly cryotherapy until cure of the lesion.

Placebo Gel 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 and Signing an ?informed consent voluntarily and knowingly.? Exclusion Criteria: Pregnant or lactating women; Concurrent or chronic illness based on previous history;Duration of lesion more than 3 months;Number of lesions more than 5;Ulcer size greater than 3 cm in their largest diameter; History of full course of standard treatment (antimonials); ?Involvement in any other drug or vaccine trial during the study period.? ?

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Reepithelization of the lesions/Complete cure. Timepoint: Monthly. Method of measurement: lesion measurement/Digital photos.	—

Secondary

Measure	Time frame
Partial cure : Decrease size of the lesions. Timepoint: Monthly. Method of measurement: lesion mesurement /Digital photos.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Fatemeh Sokhanvari MD

Skin Disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences

dr_f_sokhanvari@yahoo.com+98 31 3337 3736

Outcome results

None listed

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