Double blind, randomized clinical trial on efficacy of combination of Glucantime and topical paromomycin for the treatment of cutaneous leishmaniasis caused by Leishmania tropica
- Conditions
- Protozoal diseases.Cutaneous leishmaniasis
- Registration Number
- IRCT138904241475N5
- Lead Sponsor
- The Eastern Mediterranean Regional Office (EMRO) of the World Health Organization (WHO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 120
I) 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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete re-epithelization of all lesions with disappearance of induration. Timepoint: weekly. Method of measurement: Digital pictures.
- Secondary Outcome Measures
Name Time Method Reduction in the size of ulcer and induration. Timepoint: weekly. Method of measurement: Digital pictures.