Cutaneous Leishmaniasis. Cutaneous leishmaniasis
Conditions
Interventions
Intervention 1: Treatment group: In this group, the skin lesion of patient along with 2 cm border of healthy skin around the lesion will be disinfected with antiseptic, followed by administration of
Sponsors
TDR/EMRO /WHO
Eligibility
Sex/Gender
All
Age
2 Years to 80 Years
Inclusion criteria
Inclusion criteria: Diagnosis of cutaneous leishmaniasis by direct examination under microscopy voluntarily agreeing to participate in the study and complying with study follow-up visits will be considered for enrollment.
Exclusion criteria
Exclusion criteria: • Other forms of Leishmaniasis i.e., mucocutaneous and/or visceral leishmaniasis (clinical exclusion) Patients already receiving treatment for Cutaneous Leishmaniasis• Known hypersensitivity to stibogluconate/meglumine antimoniate Pregnancy/lactation Comorbidities or other illness which may hinder the completion and follow-up of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment of treatment efficacy in terms of treatment response among both study groups, assessed after 4-6 therapy sessions. Timepoint: Week 0, week 4, Week 8, Week 12. Method of measurement: Treatment Response labelled as: Complete response (complete re-epithelialization, disappearance of edema, induration, and other signs of inflammation), Partial response (decrease in lesion size not more than 50%, without appearance of epidermal crease)• Failure to response (no re-epithelialization). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety adverse effects. Timepoint: 0week, 4 weeks, 8 weeks, 12 weeks. Method of measurement: Assessment of treatment safety in terms of occurrence of known/unknown device and drug reactions/side effects at each follow-up visit. Safety assessment is defined as:• Local side effects o Redness, Itching, Burning, Blister formation, Oozing. | — |
Countries
Pakistan
Contacts
Public ContactNafisa Tahir
National University of Medical Sciences
Outcome results
None listed