Cutaneous leishmaniasis. Cutaneous leishmaniasis
Conditions
Interventions
Intervention 1: Treatment with multilamellar Large Vesicle (MLV) liposomes containing Azithromycin, prepared by freeze drying method, 40 mg/ml twice-daily, according to the lesion's size for 8 weeks o
Treatment - Drugs
Treatment with multilamellar Large Vesicle (MLV) liposomes containing Azithromycin, prepared by freeze drying method, 40 mg/ml twice-daily, according to the lesion's size for 8 weeks or complete heali
Treatment with interalesional meglumine antimoniate (glucantime) injection (1-2 ml) weekly untill 8 weeks or complete healing of the leishmaniasis
Sponsors
Research Council of Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: cutaneous leishmaniasis with less than 6 months duration approved by either a Giemsa direct skin smear or a positive skin biopsy of lesions, more than 3 month withdrawal from previous history of anti-leishmania therapy. Exclusion criteria: Pregnancy, breast feeding, taking any other specific treatment while participating in the study, past medical history of any systemic disease during the last 2 months, presence of known disease such as cardiac, renal or liver failure.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete healing. Timepoint: Every two weeks up to 8 weeks and then once again after 6 months and 1 year after completing the interventions. Method of measurement: measuring the size of lesion induration diameter with caliper. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: Every two weeks till 8 weeks. Method of measurement: Base on taking history and physical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHadis Yousefzadeh
Research center for skin disease and cutaneous leishmaniasis
Outcome results
None listed