Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cutaneous Leishmaniasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Imiquimod

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Catherine Royce, Dr

Role: STUDY_CHAIR

Drugs for Neglected Diseases initiative

Locations

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UPCH

Cusco, , Peru

Site Status

IMT Alexander Von Humboldt

Lima, , Peru

Site Status

Countries

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Peru

References

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Miranda-Verastegui C, Tulliano G, Gyorkos TW, Calderon W, Rahme E, Ward B, Cruz M, Llanos-Cuentas A, Matlashewski G. First-line therapy for human cutaneous leishmaniasis in Peru using the TLR7 agonist imiquimod in combination with pentavalent antimony. PLoS Negl Trop Dis. 2009 Jul 28;3(7):e491. doi: 10.1371/journal.pntd.0000491.

Reference Type DERIVED

PMID: 19636365 (View on PubMed)

Other Identifiers

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DNDi-IMQ-05

Identifier Type: -

Identifier Source: org_study_id