Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

This study has been completed.
Sponsor:
Information provided by:
Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:
NCT00257530
First received: November 22, 2005
Last updated: June 11, 2008
Last verified: June 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Drugs for Neglected Diseases

Additional 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
Study First Received: November 22, 2005
Last Updated: June 11, 2008
Health Authority: Peru: UPHC (Universidad Peruana Cayetano Heredia)
Canada: McGill University
Switzerland: Drugs for Neglected Diseases initiative

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on July 20, 2014