- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00257530
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
June 11, 2008 updated by: Drugs for Neglected Diseases
Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients
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 Overview
Study Type
Interventional
Enrollment
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cusco, Peru
- UPCH
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Lima, Peru
- IMT Alexander Von Humboldt
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Time to healing
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Reduction of scaring
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Secondary Outcome Measures
Outcome Measure |
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Safety (measured by AE reporting) during treatment and follow up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Catherine Royce, Dr, Drugs for Neglected Diseases initiative
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
November 22, 2005
First Submitted That Met QC Criteria
November 22, 2005
First Posted (Estimate)
November 23, 2005
Study Record Updates
Last Update Posted (Estimate)
June 12, 2008
Last Update Submitted That Met QC Criteria
June 11, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Euglenozoa Infections
- Leishmaniasis
- Leishmaniasis, Cutaneous
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferon Inducers
- Imiquimod
Other Study ID Numbers
- DNDi-IMQ-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cutaneous Leishmaniasis
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Medecins Sans Frontieres, NetherlandsUnknownOld World Cutaneous Leishmaniasis
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Drugs for Neglected DiseasesWellcome Trust grant 212346/Z/18/Z - 21st Century Treatments for Sustainable...CompletedVisceral Leishmaniasis | Cutaneous LeishmaniasesUnited Kingdom
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Hospital Universitário Professor Edgard SantosOswaldo Cruz Foundation; Conselho Nacional de Desenvolvimento Científico e...CompletedCutaneous Leishmaniasis, AmericanBrazil
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Fundacion Nacional de DermatologiaHospital Dermatologico de Jorochito; Ministerio de Salud de Bolivia, Programa... and other collaboratorsCompletedCutaneous Leishmaniasis, AmericanBolivia
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Centro Internacional de Entrenamiento e Investigaciones...University of TexasCompletedCutaneous Leishmaniasis (Diagnosis)Colombia
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Knight Therapeutics (USA) IncCompletedCutaneous Leishmaniasis | Mucosal LeishmaniasisUnited States
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Hospital Universitário Professor Edgard SantosInstituto Gonçalo Muniz FIOCRUZ BANot yet recruitingCutaneous Leishmaniasis, AmericanBrazil
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Centro Internacional de Entrenamiento e Investigaciones...Universidad IcesiCompletedCutaneous Leishmaniasis, AmericanColombia
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University of BrasiliaCompletedLocalized Cutaneous LeishmaniasisBrazil
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U.S. Army Medical Research and Development CommandCompletedOld World Cutaneous LeishmaniasisTunisia
Clinical Trials on Imiquimod
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Graceway Pharmaceuticals, LLCCompletedGenital WartsUnited States
-
Taro Pharmaceuticals USACompleted
-
Graceway Pharmaceuticals, LLCCompletedGenital WartsUnited States
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Graceway Pharmaceuticals, LLCCompletedKeratosisUnited States
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The University of Hong KongCompleted
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Graceway Pharmaceuticals, LLCCompletedSuperficial Basal Cell CarcinomaAustralia, New Zealand
-
Graceway Pharmaceuticals, LLCCompletedActinic KeratosisUnited States
-
Teva Pharmaceuticals USACompletedActinic KeratosisUnited States
-
Taro Pharmaceuticals USACompleted