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Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00257530
First Posted: November 23, 2005
Last Update Posted: June 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Drugs for Neglected Diseases
  Purpose
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
Cutaneous Leishmaniasis Drug: Imiquimod Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients

Resource links provided by NLM:


Further study details as provided by Drugs for Neglected Diseases:

Primary Outcome Measures:
  • Time to healing
  • Reduction of scaring

Secondary Outcome Measures:
  • Safety (measured by AE reporting) during treatment and follow up to 12 months

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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257530


Locations
Peru
UPCH
Cusco, Peru
IMT Alexander Von Humboldt
Lima, Peru
Sponsors and Collaborators
Drugs for Neglected Diseases
Investigators
Study Chair: Catherine Royce, Dr Drugs for Neglected Diseases initiative
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00257530     History of Changes
Other Study ID Numbers: DNDi-IMQ-05
First Submitted: November 22, 2005
First Posted: November 23, 2005
Last Update Posted: June 12, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers


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