Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy
Recruitment status was Recruiting
Clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of WHO-recommended multi-drug therapy (MDT). It is also known to have a beneficial effect in one of the common immunological reactions that occur in leprosy, known as erythema nodosum leprosum, or ENL. When MDT was reduced in length from 24 to 12 months, evidence suggests that ENL became worse. This study is a double-blind, randomized controlled trial examining the effect of giving an additional year of clofazimine after completion of MDT. The endpoints are the incidence and severity of ENL over a period of 3 years in the 2 groups.
Borderline Lepromatous Leprosy
Drug: Vitamin capsule
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effect of Additional Clofazimine on ENL Reactions in Leprosy|
- Incidence of ENL reactions [ Time Frame: 2 years of follow-up ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo group
These patients will receive placebo for 12 months after completion of MDT.
Drug: Vitamin capsule
Daily for 12 months
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.
|Contact: Marivic Balagon, MDfirstname.lastname@example.org|
|Contact: Paul Saunderson, MDemail@example.com|
|Cebu Skin Clinic||Recruiting|
|Cebu, Vesayas, Philippines, 6000|
|Contact: Marivic Balagon, MD firstname.lastname@example.org|
|Principal Investigator: Marivic Balagon, MD|
|Principal Investigator:||Marivic Balagon, MD||LWM|