Cutaneous leishmaniasis.
Conditions
Interventions
Group 1-Weekly intralesional injection of meglumine antimoniate (Glucantime, Rhodia Laboratories, rhone Polenc, France) up to six consecutive weeks or complete healing of the lesion Group/2-Weekly int
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: a) Parasitollogically proven cases of cutaneous leishmaniasis based on positive smear and/or culture b) Otherwise healthy subjects on the basis of medical history c)Age: 12-60 years d) willing to participate in the study and sign the informed consent (by the patient or his/her/partner/guardian) in case of younger than 18 years Exclusion criteria: a) Pregnant or lactating women b) Duration of lesions more than 3 months c) Number of lesions more than 5 d) Ulcer size greater than 5 cm in the largest diameter e) History of full course of standard treatment (antimonials) f) History of allergy to meglumine antimoniate or silver g) Serious systemic illnesses as judged by the physician h) Participation in any drug trial in the last 60 days i) Indication for administration of systemic treatment with meglumine antimoniate j) Presence of secondary bacterial infection of the lesion according to clinical appearance of the lesion
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete healing. Timepoint: at 6 weeks after initiation of the intrvention(s). Method of measurement: Lesions' assessment of healing by measuring the size of induration and ulcer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete healing. Timepoint: at 6 months after initiation of the intervention(s). Method of measurement: Lesions' assessment of healing by measuring the size of induration and ulcer.;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 ContactAlireza Firooz, MD
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences
Outcome results
None listed