Status:
COMPLETED
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
Lead Sponsor:
Drugs for Neglected Diseases
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
5-65 years
Phase:
PHASE3
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, ...
Eligibility Criteria
Inclusion
- 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
- \>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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00257530
Start Date
December 1 2005
End Date
June 1 2006
Last Update
June 12 2008
Active Locations (2)
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1
UPCH
Cusco, Peru
2
IMT Alexander Von Humboldt
Lima, Peru