Clofazamine in the Long Term Treatment of Leprosy, Phase III
| Status: | Available |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Contact: | Arnold M Henson, MD |
| Email: | arnold.m.henson@kp.org |
| Phone: | 949-932-5116 |
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.
Treatment protocol objective is to treat patients with clofazamine who meet inclusion
criteria stated above.
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 (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)
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