Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

Cutaneous Leishmaniasis Clinical Trial

Official title:

Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257530
• Other study ID #: DNDi-IMQ-05
• Status: Completed
• Phase: Phase 3
• First received: November 22, 2005
• Last updated: June 11, 2008
• Start date: December 2005
• Est. completion date: June 2006

Study information

• Verified date: June 2008
• Source: Drugs for Neglected Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: UPHC (Universidad Peruana Cayetano Heredia)Canada: McGill UniversitySwitzerland: Drugs for Neglected Diseases initiative
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• Imiquimod

Locations

Country	Name	City	State
Peru	UPCH	Cusco
Peru	IMT Alexander Von Humboldt	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Drugs for Neglected Diseases

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to healing
Primary	Reduction of scaring
Secondary	Safety (measured by AE reporting) during treatment and follow up to 12 months