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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201108301475N6
Enrollment
144
Registered
2011-10-05
Start date
2011-09-01
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 otherwise Healthy. minor skin disease

Interventions

Intervention 1: Treatment with topical Nano liposomal form of 10% paromomycin, twice a day for 28 days. Intervention 2: Placebo topically is used twice a day for 28 days.
Treatment - Drugs
Placebo
Treatment with topical Nano liposomal form of 10% paromomycin, twice a day for 28 days
Placebo topically is used twice a day for 28 days

Sponsors

Center for Research & Training in Skin Diseases & Leprosy Tehran University of Medical Sciences; Dis
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:Age 12-60 years; Cutaneous leishmaniasis (CL) lesion induced by L. major; Parasitological proven cases of CL by direct smear, culture or PCR; Healthy individual otherwise of CL; onset less than 3 months; number of lesion 5 at most; ulcer size not more than 30 mm in one size; willing to participate and sign informed consent. Exclusion criteria: pregnant or lactating women; duration of lesion more than 3 months; serious illness such as heart kidney or liver diseases based on physical exam and laboratory tests; CL lesion resistant to treatment or recidivans form of lesion; number of lesions more than 5; ulcer size more than 30 mm in one direction participation in any other clinical trial in last 6 months.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Complete cure. Timepoint: at weeks 4 and 8 and at months 3 and 6. Method of measurement: Measurement of reepithelization.

Secondary

MeasureTime frame
Partial cure. Timepoint: at weeks 4 and 8 and at months 3 and 6. Method of measurement: Measurement of reepithelization.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ali Khamesipour

Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences

khamesipour@tuma.ac.ir+98 21 8897 0657

Outcome results

None listed

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