Double blinded randomised placebo controlled phase II trial of Shiunko Ointment local application twice a day for 4 weeks in Ethiopian patients with localized cutaneous Leishmaniasis.

Double blinded randomised placebo controlled phase II trial of Shiunko Ointment local application twice a day for 4 weeks in Ethiopian patients with localized cutaneous Leishmaniasis. - Shiunko Project

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010994

Enrollment

Registered

2013-06-18

Start date

2013-04-10

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Cutaneous Leishmaniasis.

Interventions

Shiunko ointment Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Presence of new , active lesion , localized solid cutaneous leishmaniasis lesion on exposed sites like face, extremities, diagnosed by staining techniques on lesion aspirate or smear from scraping on the index lesion and PCR, with no previous treatment in the past 6 months 2. Age: 18 - 65 years 3. Has an identifiable address and expects to remain in the area for the duration of the study.

Exclusion criteria

Exclusion criteria: 1. Patients with multiple lesions,mucocutaneousand/or diffused Cutaneous Leishmaniasis 2. Abnormal biochemical and/or haematological laboratory values and considered clinically relevant. 3. Any condition which to comply with the study procedures. 4. Known hypersensitivity to any of the trial product components. 5. Pregnancy as confirmed by urine HCG in female of reproductive age

Design outcomes

Primary

Measure	Time frame
Cure rate	—

Secondary

Measure	Time frame
Safety	—

Countries

Africa

Contacts

Public ContactJuntra Karbwang Laothavorn

Nagasaki University Clinical Product Development Department

kawbwangj@nagasaki-u.ac.jp095-819-7558

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026