The effect of LeishG1 cream on cutaneous leishmaniasis

Comparing the effectiveness of Leish G1 cream with Glucantime and simultaneous use of Glucantime and LeishG1 with Glucantime and placebo on the improvement of cutaneous leishmaniasis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240304061158N1

Enrollment

120

Registered

2024-07-22

Start date

2024-04-20

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

cutaneous leishmaniasis lesion. Cutaneous leishmaniasis

Interventions

Intervention 1: Intervention 1: A number of 30 patients with small skin lesions (=5cm), will be treated with LeishG1 cream produced by Behpad Teb Company, applied twice a day in a fingertip unit as a

Eligibility

Sex/Gender

All

Age

15 Years to 60 Years

Inclusion criteria

Inclusion criteria: Maximum 4 lesions per person

Exclusion criteria

Exclusion criteria: Skin sensitivity and irritation due to drug use Simultaneous use of other drugs immunodeficiency disorders or the use of immunosuppressive drugs Pregnancy and breastfeeding ?Skin disease such as eczema, psoriasis, lupus, pemphigus, fungal lesions, etc. Mental disorders and severe mental illnesses such as depression and madness Lesions on the face or ears Lymphadenitis infection History of any other treatment for the current infection during the past three months

Design outcomes

Primary

Measure	Time frame
Lesion healing. Timepoint: The primary outcome of this study is lesion healing that will be assessed by area measurement index, which will be measured at the beginning of treatment (day zero) and on days 14, 28, 60 and 90 after the intervention. Method of measurement: Lesion healing: an ulcer that is completely re-epithelialized on days 42 to 63 and remains so on (no relapse) on days 90 and 180-360. An ulcer that is less than 50% of the initial size on day 45 and is completely re-epithelialized on both days 90 and 180-360 (no relapse).	—

Measure

Time frame

Lesion healing. Timepoint: The primary outcome of this study is lesion healing that will be assessed by area measurement index, which will be measured at the beginning of treatment (day zero) and on days 14, 28, 60 and 90 after the intervention. Method of measurement: Lesion healing: an ulcer that is completely re-epithelialized on days 42 to 63 and remains so on (no relapse) on days 90 and 180-360. An ulcer that is less than 50% of the initial size on day 45 and is completely re-epithelialized on both days 90 and 180-360 (no relapse).

—

Secondary

Measure	Time frame
Adverse events. Timepoint: Adverse reactions such as itching, redness, and burning are checked on days 14, 28, 60, and 90. Method of measurement: Doctor examination and patient report.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNazli Ansari

Isfahan Skin diseases and Leishmaniasis Research Center

nazli_md@hotmail.com+98 31 3335 9090

Outcome results

None listed

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