Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy
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|ClinicalTrials.gov Identifier: NCT01290744|
Recruitment Status : Completed
First Posted : February 7, 2011
Last Update Posted : June 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Borderline Lepromatous Leprosy Lepromatous Leprosy||Drug: Clofazimine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Additional Clofazimine on ENL Reactions in Leprosy|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Placebo Comparator: Placebo group
These patients will receive placebo for 12 months after completion of MDT.
Daily for 12 months
Other Name: Vitamin capsule
Experimental: Clofazimine for 12 months after MDT
Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.
Clofazimine 100mg daily for 12 months after completion of MDT.
Other Name: Lamprene
- Incidence of ENL reactions [ Time Frame: 2 years of follow-up ]The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.
- Severity of ENL reactions [ Time Frame: 2 years of follow-up ]The hypothesis is that additional clofazimine will reduce severity of ENL reactions, as well as incidence. Severity will be monitored by three indicators: 1. a rather crude clinical score (mild, moderate or severe), 2. the total dose of prednisolone given to treat ENL reactions, 3. the total duration of ENL symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290744
|Cebu Skin Clinic|
|Cebu, Vesayas, Philippines, 6000|
|Principal Investigator:||Marivic Balagon, MD||LWM|