Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy (NCT00852345) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy
United States
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.