Imiquimod in Combination With Meglumine Antimoniate for Cutaneous Leishmaniasis: A Randomized Assessor-Blind Controlled Trial
Phase 2
- Conditions
- Cutaneous leishmaniasis.
- Registration Number
- IRCT138706111166N1
- Lead Sponsor
- the Joint World Health Organization Eastern Mediterranean Region Division of Communicable Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
(1) parasitologically proven cases of CL based on positive smear or culture
(2) otherwise healthy subjects
(3) age 12 to 60 years
(4) willingness to participate in the study and sign the informed consent (by the patient or his or her parent or guardian in patients younger than 18 years)
Exclusion criteria:
(1) pregnant or lactating women,
(2) duration of lesions longer than 6 months
(3) number of lesions more than 5
(4) any lesions larger than 5 cm
(5) history of any standard course of treatment with antimonials
(6) history of allergy to antimonials
(7) serious systemic illnesses (as judged by the physician)
(8) participation in any drug trials in the last 60 days.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical cure(more than 75% reduction in the size of lesions compared with baseline). Timepoint: Baseline - Weeks 4 and 8. Method of measurement: Measurement of induration, ulcer and erythema size with a ruler.
- Secondary Outcome Measures
Name Time Method Adverse effects. Timepoint: Baseline - Weeks 4 and 8. Method of measurement: Medical history taking and physical examination.;Clinical improvement (50%-75% reduction in the size of lesions compared with the baseline). Timepoint: Baseline - Weeks 4 and 8. Method of measurement: Measurement of the size of induration, ulecr and erythema of the lesion(s) with a ruler.