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Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

Information source: Kaiser Permanente
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leprosy

Intervention: clofazamine (Drug)

Phase: N/A

Status: No longer available

Sponsored by: Kaiser Permanente

Official(s) and/or principal investigator(s):
Arnold M Henson, MD, Principal Investigator, Affiliation: Kaiser Permanente

Summary

Clofazimine has shown effectiveness in the treatment of leprosy for many years. The World Health Organization and the National Hansen's Disease Program consider clofazamine to be standard therapy for treatment of multibacillary leprosy. In recent years, the availability of the drug has become limited and is currently available only under a research protocol and is considered "investigational." Use of Clofazamine in patients presenting with lepromatous leprosy is necessary for patients exhibiting nerve involvement or lesions resistant to other therapies. This drug will be used prospectively for patients who require treatment of leprosy as deemed appropriate by a Kaiser Permanente Southern California physician.

Clinical Details

Official title: Clofazamine in the Long Term Treatment of Leprosy, Phase III

Study design: N/A

Detailed description: Treatment protocol objective is to treat patients with clofazamine who meet inclusion criteria stated above.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Known or suspected leprosy confirmed by skin biopsy and/or slit skin smears.

- Multibacillary leprosy (lepromatous leprosy or borderline-lepromatous).

- Paucibacillary leprosy (borderline, borderline tuberculoid, or indeterminate) if

there is involvement of the cranial nerves or active acute neuritis.

- Known or suspected ENL(erythema nodosum leprosum) (a specific immune reaction with

painful skin nodules and fever)

- Known or suspected dapsone-resistant leprosy or relapsed leprosy.

- Intolerance of other antileprosy antibiotic (where clofazamine is substituted as

apart of multidrug regimen) Exclusion Criteria:

- Uncomplicated paucibacillary leprosy which would otherwise be treated with dapsone

and rifampin only.

- Known prior intolerance of Clofazamine

- Any minor (even with parental consent)

- Any fertile woman who is pregnant a specific immune reaction with painful skin rash

and fever)

Locations and Contacts

Kaiser Permanente, Irvine, California 92618, United States
Additional Information


Last updated: April 2, 2015

Page last updated: August 23, 2015

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