Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

This study has been completed.

First Received: November 22, 2005 Last Updated: June 11, 2008 History of Changes

Sponsored by:	Drugs for Neglected Diseases
Information provided by:	Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:	NCT00257530

Purpose

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.

Condition	Intervention	Phase
Cutaneous Leishmaniasis	Drug: Imiquimod	Phase III

MedlinePlus related topics: Leishmaniasis

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Double Blind Clinical Trial of Imiquimod (Aldara) Versus Placebo Used in Combination With Pentavalent Antimony (Glucantime) in Peruvian Cutaneous Leishmaniasis Patients

Further study details as provided by Drugs for Neglected Diseases:

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

Estimated Enrollment:	80
Study Start Date:	December 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	5 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257530

Locations

Peru
UPCH
Cusco, Peru
IMT Alexander Von Humboldt
Lima, Peru

Sponsors and Collaborators

Drugs for Neglected Diseases

Investigators

Study Chair:

Catherine Royce, Dr

Drugs for Neglected Diseases initiative

More Information

No publications provided

Study ID Numbers:	DNDi-IMQ-05
Study First Received:	November 22, 2005
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00257530 History of Changes
Health Authority:	Peru: UPHC (Universidad Peruana Cayetano Heredia); Canada: McGill University; Switzerland: Drugs for Neglected Diseases initiative

Study placed in the following topic categories:

Leishmaniasis
Protozoan Infections
Skin Diseases, Infectious
Immunologic Factors
Skin Diseases
Interferons

Meglumine antimoniate
Adjuvants, Immunologic
Imiquimod
Parasitic Diseases
Leishmaniasis, Cutaneous

Additional relevant MeSH terms:

Leishmaniasis
Interferon Inducers
Protozoan Infections
Immunologic Factors
Skin Diseases, Parasitic
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic

Mastigophora Infections
Imiquimod
Leishmaniasis, Cutaneous
Pharmacologic Actions
Skin Diseases, Infectious
Therapeutic Uses
Sarcomastigophora Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 07, 2009