Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

Drugs for Neglected Diseases80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cutaneous Leishmaniasis

Interventions

ImiquimodDRUG

Eligibility

Sex: ALLMin age: 5 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

UPCH

Cusco, Peru

IMT Alexander Von Humboldt

Lima, Peru

Outcomes

Primary Outcomes

Time to healing

Reduction of scaring

Secondary Outcomes

Safety (measured by AE reporting) during treatment and follow up to 12 months

Data from ClinicalTrials.gov

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