Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
Phase 3
Completed
- Conditions
- Cutaneous Leishmaniasis
- Registration Number
- NCT00257530
- Lead Sponsor
- Drugs for Neglected Diseases
- Brief Summary
This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Males/Females between 5 and 65 yrs
- CL diagnosis confirmed
- >4 weeks time disease
- no prior anti-leishmanial therapy for CL
- negative pregnancy test
- informed written consent or parent consent for <18yrs patients
Exclusion Criteria
- >25cm2 lesion(s)
- >6 cutaneous lesions
- mucosal lesion
- previous exposure to Imiquimod or anti-leish treatment
- participation in another protocol within 30 days prior study
- other acute or chronic illness / medication that may interfere
- significant psychiatric illness
- anaphylaxis or severe allergic reaction to proposed drugs
- patients unlikely to cooperate
- concomitant infection
- pregnancy or breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to healing Reduction of scaring
- Secondary Outcome Measures
Name Time Method Safety (measured by AE reporting) during treatment and follow up to 12 months
Trial Locations
- Locations (2)
UPCH
🇵🇪Cusco, Peru
IMT Alexander Von Humboldt
🇵🇪Lima, Peru