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...
Date First Received: November 22, 2005
Last Updated: June 11, 2008
Verified by: Drugs for Neglected Diseases, June 2008
Clinical Trial Phase: Phase 3 | Start Date: December 2005
Overall Status: Completed
Estimated Enrollment: 80
Brief Summary
Official Title: “Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: June 2006
Intervention(s) in this Clinical Trial
- Drug: Imiquimod
Outcome Measures for this Clinical Trial
Primary Measures
- Time to healing
- Reduction of scaring
Secondary Measures
- Safety (measured by AE reporting) during treatment and follow up to 12 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 5 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Drugs for Neglected Diseases
Overall Clinical Trial Officials and Contacts
Catherine Royce, Dr Study Chair Drugs for Neglected Diseases initiative
Additional Information
Information obtained from ClinicalTrials.gov on October 06, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00257530
Study ID Number: DNDi-IMQ-05
ClinicalTrials.gov Identifier: NCT00257530
Health Authority: Peru: UPHC (Universidad Peruana Cayetano Heredia)
Clinical Trials Authorship and Review
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