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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
History of Changes

November 22, 2005
June 11, 2008
December 2005
June 2006   (final data collection date for primary outcome measure)
  • Time to healing
  • Reduction of scaring
Same as current
Complete list of historical versions of study NCT00257530 on ClinicalTrials.gov Archive Site
Safety (measured by AE reporting) during treatment and follow up to 12 months
Same as current
 
 
 
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
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.
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Cutaneous Leishmaniasis
Drug: Imiquimod
 
Miranda-Verastegui C, Tulliano G, Gyorkos TW, Calderon W, Rahme E, Ward B, Cruz M, Llanos-Cuentas A, Matlashewski G. First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony. PLoS Negl Trop Dis. 2009 Jul 28;3(7):e491.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2006
June 2006   (final data collection date for primary outcome measure)

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
Both
5 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT00257530
DNDi-IMQ-05
 
 
Drugs for Neglected Diseases
 
Study Chair: Catherine Royce, Dr Drugs for Neglected Diseases initiative
Drugs for Neglected Diseases
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP