"Safety Evaluation of Topical Application of Nano-Liposomal Amphotericin B (Sinaampholeish)"

Safety Evaluation of Topical Application of Nano-Liposomal Form of Amphotericin B (Sinaampholeish) in comparison with placebo on Healthy Volunteers; Phase I Clinical Trial.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20081130001475N12

Enrollment

Registered

2019-02-21

Start date

2012-06-13

Completion date

Unknown

Last updated

2019-02-25

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: Intervention group: Topical Nano-liposomal formulation of 0.4% Amphotericin B was applied on the left or right volar side of forearm twice a day for one week. Intervention 2: Control g

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Healthy volunteer aged between 18-65 willingness to participate in the study and signing the informed consent form

Exclusion criteria

Exclusion criteria: Any disease or illness according to subject history Mentally ill based on physician diagnosis participating in other concurrent trial

Design outcomes

Primary

Measure	Time frame
Erythema. Timepoint: Daily evaluation after the 1st day of intervention to 7th day. Method of measurement: clinical exam.;Pruritus. Timepoint: Daily evaluation after the 1st day of intervention to 7th day. Method of measurement: clinical Exam.	—

Secondary

Measure	Time frame
Any reported adverse events. Timepoint: Daily evaluation after the 1st day of intervention to 7th day. Method of measurement: Participants history.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Firooze

Tehran University of Medical Sciences

firozali@sina.tums.ac.ir+98 21 8897 0657

Outcome results

None listed

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