Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

Drugs for Neglected Diseases

Status and phase: Completed; Phase 3

Conditions: Cutaneous Leishmaniasis

Treatments: Drug: Imiquimod

Study type: Interventional

Funder types: Other

Identifiers

NCT00257530

DNDi-IMQ-05

Details and patient eligibility

About

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.

Sex: All

Ages: 5 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind