Cutaneous leishmaniasis
Conditions
Interventions
Consenting patients will be randomized into three arms in 2: 2: 1 ratio considering the unwanted effects that may arise with 15% hypertonic saline. The first arm (A) will receive intralesional sodium
Sponsors
Teaching Hospital Anuradhapura
Eligibility
Inclusion criteria
Inclusion criteria: All consenting patients presenting to the Skin Clinic, Teaching Hospital, Anuradhapura with a clinical diagnosis of cutaneous leishmaniasis, confirmed by slit-skin smear will be included.
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Breast feeding 3. Known renal impairment 4. Known liver impairment 5. Congestive cardiac failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Status of the skin lesion [• Weekly for the first to third injections • Every two weeks for the fourth and fifth injections • Monthly thereafter until the injections are complete (7 injections for arm A and 10 injections for arms B and C). ] Side effects at the site of the lesion due to the injections [• Weekly for the first to third injections • Every two weeks for the fourth and fifth injections • Monthly thereafter until the injections are complete (7 injections for arm A and 10 injections for arms B and C).] Duration of treatment [• Weekly for the first to third injections • Every two weeks for the fourth and fifth injections • Monthly thereafter until the injections are complete (7 injections for arm A and 10 injections for arms B and C). ] Duration taken for cure [• Weekly for the first to third injections • Every two weeks for the fourth and fifth injections • Monthly thereafter until the injections are complete (7 injections for arm A and 10 injections for arms B and C). ] Clinical response: graded as slight (10% improvement), mild (30%), moderate (50%), marked improvement (70-80%) and total clearance of the lesion. Both marked improvements and total clearance will be considered as cure. [• Weekly for the first to third injections • Every two weeks for the fourth and fifth injections • Monthly thereafter until the injections are complete (7 injections for arm A and 10 injections for arms B and C). ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Parasitological cure (negative slit skin smear) [At the time of clinical cure] | — |
Countries
Sri Lanka
Contacts
Public ContactRanthilaka Ranawaka
Consultant Dermatologist
Outcome results
None listed