Back to resultsImiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
Primary Purpose
Cutaneous Leishmaniasis
Status
Completed
Phase
Phase 3
Locations
Peru
Study Type
Interventional
Intervention
Imiquimod
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Leishmaniasis
Eligibility 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
Sites / Locations
- UPCH
- IMT Alexander Von Humboldt
Outcomes
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
Full Information
NCT ID
NCT00257530
First Posted
November 22, 2005
Last Updated
June 11, 2008
Sponsor
Drugs for Neglected Diseases
1. Study Identification
Unique Protocol Identification Number
NCT00257530
Brief Title
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
Official Title
Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Drugs for Neglected Diseases
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Leishmaniasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Primary Outcome Measure Information:
Title
Time to healing
Title
Reduction of scaring
Secondary Outcome Measure Information:
Title
Safety (measured by AE reporting) during treatment and follow up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Royce, Dr
Organizational Affiliation
Drugs for Neglected Diseases initiative
Official's Role
Study Chair
Facility Information:
Facility Name
UPCH
City
Cusco
Country
Peru
Facility Name
IMT Alexander Von Humboldt
City
Lima
Country
Peru
12. IPD Sharing Statement
Citations:
PubMed Identifier
19636365
Citation
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. doi: 10.1371/journal.pntd.0000491.
Results Reference
derived
Learn more about this trial
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
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