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Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

Information source: Drugs for Neglected Diseases
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cutaneous Leishmaniasis

Intervention: Imiquimod (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Drugs for Neglected Diseases

Official(s) and/or principal investigator(s):
Catherine Royce, Dr, Study Chair, Affiliation: Drugs for Neglected Diseases initiative

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.

Clinical Details

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

Primary outcome:

Time to healing

Reduction of scaring

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

Eligibility

Minimum age: 5 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

UPCH, Cusco, Peru

IMT Alexander Von Humboldt, Lima, Peru

Additional Information

Starting date: December 2005
Last updated: June 11, 2008

Page last updated: August 23, 2015

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