| Trial name or title | Randomised, double‐blind, controlled study on efficacy and safety of intralesional metronidazole vs intralesional sodium stibogluconate in L donovani cutaneous leishmaniasis |
| Methods | Randomised controlled trial |
| Participants |
Inclusion criteria: > 12 years of age, positive slit skin smear and/or skin biopsy for Leishmania parasites Exclusion criteria: pregnancy, breastfeeding, known renal impairment, known liver impairment, congestive cardiac failure |
| Interventions |
Group 1: intralesional metronidazole 0.2‐4 mL per lesion depending on the size of the lesion, weekly until cure or maximum of 10 injections Group 2: intralesional stibogluconate 0.2‐4 mL per lesion depending on the size of the lesion, weekly until cure or maximum of 10 injections |
| Outcomes |
Rate of clinical cure Adverse effects – anticipated local side effects are pain, ulceration, scarring, postinflammatory hyperpigmentation or depigmentation. Systemic side effects are not anticipated as the drug is given intralesionally. |
| Starting date | November 2014 |
| Contact information | Ranthilaka R Ranawaka 0112855200 ranthilaka37@yahoo.com |
| Notes | — |
CL: cutaneous leishmaniasis; ECG: electrocardiogram; ILMA: intralesional meglumine antimoniate.