Cutaneous leishmaniasis. Cutaneous Leishmaniasis
Conditions
Interventions
Intervention 1: Multilamellar Large Vesicle (MLV) liposomes containing Amphotricin B, prepared by freeze drying method, 3-7 drops twice-daily, according to the lesion's size for 8 weeks or complete he
Treatment - Drugs
Multilamellar Large Vesicle (MLV) liposomes containing Amphotricin B, prepared by freeze drying method, 3-7 drops twice-daily, according to the lesion's size for 8 weeks or complete healing of the les
Intralesional glucantime (Specia®, France) once a week, to the point when the lesion’s surface became fully infiltrated, up to a maximum dose of 2 ml for 8 weeks
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: Presence of cutaneous leishmaniasis approved by either a direct smear stained with Giemsa or a positive skin biopsy of lesions with less than 6 months duration, in cases of previous history of anti-leishmania therapy, a 3 month treatment free interval from the last treatment course Exclusion criteria: Pregnancy, breast feeding, taking any other specific treatment while participating in the study, past medical history of any local or systemic disease during the last 2 months, presence of significant underlying disease such as cardiac, renal or liver dysfunction
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete healing. Timepoint: First time within 8 weeks after beginning of treatment and second one after 6 months after initiation of the intervention(s). Method of measurement: Measuring the size of induration and ulcer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Effects. Timepoint: Recorded at each follow-up visit. Method of measurement: Taking medical history and performing physical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Pouran Layegh
Department of Dermatology, Qaem Hospital, Mashad University of Medical Sciences
Outcome results
None listed