Protozoal diseases. Cutaneous leishmaniasis
Conditions
Interventions
Intervention 1: Control:Glucantime (60 mg/kg/day) intramuscularly for 21days together with topical placebo twice daily for 28 days. Intervention 2: Intervention:Glucantime (60 mg/kg/day) intramuscular
Placebo
Treatment - Drugs
Control:Glucantime (60 mg/kg/day) intramuscularly for 21days together with topical placebo twice daily for 28 days
Intervention:Glucantime (60 mg/kg/day) intramuscularly for 21days together with topical Lip-PM twice a day for 28 days
Sponsors
The Eastern Mediterranean Regional Office (EMRO) of the World Health Organization (WHO)
Eligibility
Sex/Gender
All
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: I) Inclusion criteria:a) Parasitologically proven cases* of CL based on positive smear and/or culture; b) Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician); c) Age 12-60 years; d) Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years). * Direct smear, culture and PCR will be done on every sample to identify the causative agent. II) Exclusion criteria: a) Pregnant or lactating women; b) Duration of lesion more than 6 months; c) Number of lesions more than 4; d) Ulcer size greater than 3 cm in their largest diameter; e) History of full course of standard treatment (antimonials); f) History of allergy to Glucantime; g) Serious systemic illnesses (as judged by the physician); h) Participation in any drug trials in the last 60 days.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete re-epithelization of all lesions with disappearance of induration. Timepoint: weekly. Method of measurement: Digital pictures. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in the size of ulcer and induration. Timepoint: weekly. Method of measurement: Digital pictures. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Khamesipour
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences
Outcome results
None listed