Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy
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ClinicalTrials.gov Identifier: NCT00852345
Expanded Access Status :
No longer available
First Posted : February 27, 2009
Last Update Posted : April 3, 2015
Health Resources and Services Administration (HRSA)
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.
Condition or disease
Treatment protocol objective is to treat patients with clofazamine who meet inclusion criteria stated above.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
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)
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)