A Phase 111 Randomized controlled clinical trial to compare the efficacy and safety of intra-lesional sodium stibogluconate with intra-lesional meglumine antimoniate treatment in patients with cutaneous leishmaniasis in Sri Lanka.

A Phase 111 Randomized controlled clinical trial to compare the efficacy and safety of intra-lesional sodium stibogluconate and intra-lesional meglumine antimoniate treatment in patients with cutaneous leishmaniasis in Sri Lanka

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2025/020

Enrollment

Unknown

Registered

2025-04-30

Start date

2025-05-19

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Cutaneous leishmaniasis

Interventions

Study settings: The study will be conducted in 4 hospital-based dermatology clinics situated in 4 CL endemic districts in Sri Lanka where a Consultant Dermatologist is stationed (Polonnaruwa, Hambanto

Eligibility

Inclusion criteria

Inclusion criteria: • Males and females aged 18 years and above. • The patient should have a positive slit skin smear for Leishmania amastigotes before enrolling into the study. Patients should have 4 or less lesions and having the longest diameter of less than or equal to 4 cm.

Exclusion criteria

Exclusion criteria: • Patients having co-morbidities (diabetes mellitus, hypertension, ischemic heart disease, hormonal imbalances, immune system related diseases, allergies and any other chronic disease that could affect wound healing) • Patients having previously treated or infected CL lesion/s • Females who are pregnant, lactating or females of reproductive age (15-49 years) who are planning for a pregnancy • Those who are living in a different endemic area • The following persons will also be excluded: those with lesions > 4cm in diameter, having >4 lesions/person, if the lesion/s are/in the periorbital area, nose, pinna of ear, joints, overlying cartilage that requires treatment with IM-SSG/MA • Any person who has travelled abroad to a leishmaniasis endemic country within the last year.

Design outcomes

Primary

Measure	Time frame
Expected efficacy is 80% clinical cure rates at the end of 12 weeks and the rest to be taken as non-responders Complete clinical cure is defined as: complete re-epithelialization and complete flattening of the edge of the lesion in ulcerated lesions or complete flattening of the lesion (in non-ulcerated lesions). [12 weeks]	—

Secondary

Measure	Time frame
To compare the safety profile of SSG with MA as the secondary endpoint with regards to Adverse events of intra-lesional pentavalent antimonials (for both SSG & MA) include: 1. Local pain 2. Local allergic reaction (dermatosis, eczema) 3. Peri-lesional pruritus 4. Transient peri-lesional erythema 5. Peri-lesional oedema 6. Skin ulceration 7. Secondary bacterial infections during treatment 8. Rarely anaphylaxis [From first day of initiation of treatment to 180 days (6 months)]	—

Measure

Time frame

To compare the safety profile of SSG with MA as the secondary endpoint with regards to Adverse events of intra-lesional pentavalent antimonials (for both SSG & MA) include: 1. Local pain 2. Local allergic reaction (dermatosis, eczema) 3. Peri-lesional pruritus 4. Transient peri-lesional erythema 5. Peri-lesional oedema 6. Skin ulceration 7. Secondary bacterial infections during treatment 8. Rarely anaphylaxis [From first day of initiation of treatment to 180 days (6 months)]

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Countries

Sri Lanka

Contacts

Public ContactShalindra Ranasinghe

Professor in Parasitology

ishalindra@sjp.ac.lk0112801028

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026