Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

Kaiser Permanente

Status

Conditions: Leprosy

Treatments: Drug: clofazamine

Study type: Expanded Access

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00852345

IRB 5347

KPSC IRB 5347 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)