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Treatment for leishmaniasis

Randomized, double blind, controlled study on efficacy and safety of intralesional metronidazole vs intralesional sodium stibogluconate in L. donovani cutaneous leishmaniasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2014/028
Enrollment
Unknown
Registered
2014-10-18
Start date
2014-11-01
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

Consenting participants meeting inclusion/exclusion criteria will be randomized into two arms. Arm 1 (intervention arm) will receive intralesional metronidazole 0.2-4ml per lesion depending on the si

Sponsors

Base Hospital Hambanthota
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. >12 years of age 2. Positive slit skin smear and /or skin biopsy for leishmania parasites

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Breast feeding 3. Known renal impairment 4. Known liver impairment 5. Congestive cardiac failure

Design outcomes

Primary

MeasureTime frame
1. Rate of clinical cure 2. Side effects to drugs – anticipated local side effects are pain, ulceration, scarring, post inflammatpry hyperpigmentation or depigmentation. (Systemic side effects are not anticipated as the drug is given intralesional) [1. At 12 weeks 2. Weekly until end of the intralesional therapy, then every 3 months for a total of 12 months]—

Secondary

MeasureTime frame
1. Recurrence rate 2. Evidence of viceralization [Every 3 months from clinical cure for a total of 12 months]—

Countries

Sri Lanka

Contacts

Public ContactRanthilaka R. Ranawaka

Consultant Dermatologist

ranthilaka37@yahoo.com0112855200

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026