Cutaneous leishmaniasis is caused by an “intracellular parasite” that is transferred to humans by a sand fly bite. It is endemic throughout Asia, Africa, Mediterranean region and America. It is estimated that there are between 0.7 to 1.2 million new cases of CL per year worldwide. It is a neglected third commonest vector borne disease in the world. It is widely spread in different parts of the world including South and Central America, Mediterranean Basin, Middle East and Central Asia.Leishmani
Conditions
Interventions
Intervention group: Confirmed cases of cutaneous leishmaniasis will be divided into 02 groups .Group-A and Group-B. Group-A will receive intralesional meglumine antimoniate weekly and Group-B will rec
Sponsors
Armed forces Hospital PNS Shifa Hospital Karachi, Pakistan
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: ·Patients between 16-60 years of age, patients with positive smear or skin biopsies for amastigotes, lesions four or less in number and no lesion more than 4cm in size.· Either gender· Willing to provide informed consent.
Exclusion criteria
Exclusion criteria: Pregnant or lactating women, sporotrichoid spread, use of any anti-leishmania treatment in the past 3 months, lesions at sites that merit systemic antimonials, allergy to antimonials and patients with history of liver disease,patient having G6PD deficiency will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy will be labeled if patients with CL lesion in either group showed complete response; complete re-epithelialization, disappearance of edema, induration, lesions becoming flatter and turning from erythematous to residual hyperpigmentation in colour assessed on photograph and clinical examination. Timepoint: Patient will be assessed before intervention and 4th ,8th , 12th , 16th weeks after intervention. Method of measurement: Patients having a typical, non-healing, painless, indurated papule, nodule, or plaque with or without crust on clinical assessment will labeled as having cutaneous leishmaniasis and will be confirmed by a direct smear taken from the lesions, which will then be stained with Giemsa stain showing Leishman bodies (amastigotes) on microscopic examination. , Skin biopsy to be done if required to confirm diagnosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects: Monitoring and documenting adverse effects related to the treatment, such as hemolysis, methemoglobinemia, peripheral neuropathy, allergic dermatitis, headache,. Timepoint: 4th, 8th, 12th, 16th weeks. Method of measurement: Patients having a typical, non-healing, painless, indurated papule, nodule, or plaque with or without crust on clinical assessment will labeled as having cutaneous leishmaniasis and will be confirmed by a direct smear taken from the lesions, which will then be stained with Giemsa stain showing Leishman bodies (amastigotes) on microscopic examination. , Skin biopsy to be done if required to confirm diagnosis. | — |
Countries
Pakistan
Contacts
Public ContactDr ATIYA RAHMAN
Armed forces Hospital , PNS SHIFA
Outcome results
None listed