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Sponsored by: |
Drugs for Neglected Diseases |
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Information provided by: | Drugs for Neglected Diseases |
ClinicalTrials.gov Identifier: | NCT00257530 |
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.
Condition | Intervention | Phase |
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Cutaneous Leishmaniasis |
Drug: Imiquimod |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients |
Estimated Enrollment: | 80 |
Study Start Date: | December 2005 |
Study Completion Date: | June 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 5 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | DNDi-IMQ-05 |
Study First Received: | November 22, 2005 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00257530 History of Changes |
Health Authority: | Peru: UPHC (Universidad Peruana Cayetano Heredia); Canada: McGill University; Switzerland: Drugs for Neglected Diseases initiative |
Leishmaniasis Protozoan Infections Skin Diseases, Infectious Immunologic Factors Skin Diseases Interferons |
Meglumine antimoniate Adjuvants, Immunologic Imiquimod Parasitic Diseases Leishmaniasis, Cutaneous |
Leishmaniasis Interferon Inducers Protozoan Infections Immunologic Factors Skin Diseases, Parasitic Skin Diseases Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic |
Mastigophora Infections Imiquimod Leishmaniasis, Cutaneous Pharmacologic Actions Skin Diseases, Infectious Therapeutic Uses Sarcomastigophora Infections Parasitic Diseases |